Clinical Trial Results:
A Phase 3, Randomized, ActiveControlled, DoubleBlind Trial Evaluating the Safety, Tolerability, and Immunogenicity of 3 Lots of 13valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Summary


EudraCT number 
200800368838 
Trial protocol 
Outside EU/EEA 
Global end of trial date 
09 Jun 2008

Results information


Results version number 
v1(current) 
This version publication date 
29 Jun 2016

First version publication date 
06 Aug 2015

Other versions 
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information


Trial identification


Sponsor protocol code 
6096A13005


Additional study identifiers


ISRCTN number 
  
US NCT number 
NCT00444457  
WHO universal trial number (UTN) 
  
Sponsors


Sponsor organisation name 
Pfizer, Inc


Sponsor organisation address 
235 E 42nd Street, New York, United States, NY 10017


Public contact 
Clinical Trials.gov Call Center, Pfizer Inc, 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com


Scientific contact 
Clinical Trials.gov Call Center, Pfizer Inc, 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com


Paediatric regulatory details


Is trial part of an agreed paediatric investigation plan (PIP) 
No


Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Results analysis stage


Analysis stage 
Final


Date of interim/final analysis 
06 Nov 2009


Is this the analysis of the primary completion data? 
No


Global end of trial reached? 
Yes


Global end of trial date 
09 Jun 2008


Was the trial ended prematurely? 
No


General information about the trial


Main objective of the trial 
To demonstrate that the immune responses induced by 3 lots of13 valent pneumococcal conjugate vaccine (13vPnC) are equivalent when measured 1 month after the infant series.
To demonstrate that the immune responses induced by Pediarix given with 13vPnC are noninferior to the immune responses induced by Pediarix given with 7 valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the infant series.Responses to the following antigens in.Pediarix will be assessed: tetanus; poliovirus types 1, 2, and 3; and hepatitis B.
To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).


Protection of trial subjects 
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.


Background therapy 
  
Evidence for comparator 
  
Actual start date of recruitment 
15 Aug 2007


Long term followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
No


Population of trial subjects


Number of subjects enrolled per country 

Country: Number of subjects enrolled 
United States: 1712


Worldwide total number of subjects 
1712


EEA total number of subjects 
0


Number of subjects enrolled per age group 

In utero 
0


Preterm newborn  gestational age < 37 wk 
0


Newborns (027 days) 
0


Infants and toddlers (28 days23 months) 
1712


Children (211 years) 
0


Adolescents (1217 years) 
0


Adults (1864 years) 
0


From 65 to 84 years 
0


85 years and over 
0



Recruitment


Recruitment details 
  
Preassignment


Screening details 
A total of 1712 subjects from United States were enrolled in the study. The study started on 15 Aug 2007 and completed on 09 Jun 2008.  
Period 1


Period 1 title 
Infant Series


Is this the baseline period? 
Yes  
Allocation method 
Randomised  controlled


Blinding used 
Double blind  
Roles blinded 
Subject, Investigator, Carer, Assessor  
Arms


Are arms mutually exclusive 
Yes


Arm title

13vPnC (Pilot Lot 1) Infant Series  
Arm description 
Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available (Haemophilus influenzae type b) Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
Experimental  
Investigational medicinal product name 
13vPnC


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
13vPnC was administered at a dose of 0.5 (milliliter) mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Pediarix


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Hib


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Hib was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).


Arm title

13vPnC (Pilot Lot 2) Infant Series  
Arm description 
Subjects received 1 single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
Experimental  
Investigational medicinal product name 
13vPnC Pilot lot 2


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
13vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Pediarix


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Hib


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Hib was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).


Arm title

13vPnC (Manufacturing lot) Infant series  
Arm description 
Subjects received 1 single 0.5 mL dose of 13vPnC manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series; coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
Experimental  
Investigational medicinal product name 
13vPnC (Manu lot)


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
13vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Pediarix


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Pediarix


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).


Arm title

7vPnC Infant series  
Arm description 
Subjects received 1 single 0.5 mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
Active comparator  
Investigational medicinal product name 
7vPnC Infant series


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
7vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Pediarix


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
Hib


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
Hib was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).




Period 2


Period 2 title 
After Infant Series


Is this the baseline period? 
No  
Allocation method 
Randomised  controlled


Blinding used 
Double blind  
Roles blinded 
Investigator, Carer, Assessor, Subject  
Arms


Are arms mutually exclusive 
Yes


Arm title

13vPnC (Pilot Lot 1) After Infant Series  
Arm description 
Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (in infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
No intervention  
Investigational medicinal product name 
No investigational medicinal product assigned in this arm


Arm title

13vPnC (Pilot Lot 2) After Infant Series  
Arm description 
Subjects received single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (in infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
No intervention  
Investigational medicinal product name 
No investigational medicinal product assigned in this arm


Arm title

13vPnC (Manufacturing lot) After Infant series  
Arm description 
Subjects received single dose of 13vPnC manu lot at 2, 4, and 6 months of age (in infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
No intervention  
Investigational medicinal product name 
No investigational medicinal product assigned in this arm


Arm title

7vPnC After Infant series  
Arm description 
Subjects received 1 single 0.5 mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Arm type 
No intervention  
Investigational medicinal product name 
No investigational medicinal product assigned in this arm




Notes [1]  The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: The subjects in this group received only the toddler dose. 

Period 3


Period 3 title 
Toddler Dose


Is this the baseline period? 
No  
Allocation method 
Randomised  controlled


Blinding used 
Double blind  
Roles blinded 
Subject, Investigator, Carer, Assessor  
Arms


Are arms mutually exclusive 
Yes


Arm title

13vPnC (Pilot Lot 1) Toddler Dose  
Arm description 
Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1 at 12 months of age (toddler dose); a commercially available (Measles, Mumps, and Rubellavaricella vaccine) MMRvaricella, or if not available, a commercially available MMR at 12 months of age and a commercially available varicella vaccine administered in separate injections; and a commercially available (hepatitis A vaccine) HAV administered at 12 months of age.  
Arm type 
Experimental  
Investigational medicinal product name 
13vPnC


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
13vPnC was administered at a dose of 0.5 (milliliter) mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).


Investigational medicinal product name 
MMRvaricella


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
MMRvaricella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.


Investigational medicinal product name 
HAV


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.


Arm title

13vPnC (Pilot Lot 2) Toddler dose  
Arm description 
Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 2 at 12 months of age (toddler dose); a commercially available MMRvaricella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.  
Arm type 
Experimental  
Investigational medicinal product name 
13vPnC


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
113vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 12 months of age (toddler dose).


Investigational medicinal product name 
MMRvaricella


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
MMRvaricella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.


Investigational medicinal product name 
HAV


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.


Arm title

13vPnC (Manufacturing lot) Toddler dose  
Arm description 
Subjects received 1 single 0.5 mL dose of 13vPnC manu lot at 12 months of age (toddler dose); a commercially available MMRvaricella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.  
Arm type 
Experimental  
Investigational medicinal product name 
13vPnC


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
13vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 12 months of age (toddler dose).


Investigational medicinal product name 
MMRvaricella


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
MMRvaricella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.


Investigational medicinal product name 
HAV


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.


Arm title

7vPnC Toddler Dose  
Arm description 
Subjects received 1 single 0.5 mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose); a commercially available MMRvaricella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.  
Arm type 
Active comparator  
Investigational medicinal product name 
7vPnC


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
7vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 12 months of age (toddler dose).


Investigational medicinal product name 
MMRvaricella


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
MMRvaricella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.


Investigational medicinal product name 
HAV


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Intramuscular use


Dosage and administration details 
HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.





Baseline characteristics reporting groups


Reporting group title 
13vPnC (Pilot Lot 1) Infant Series


Reporting group description 
Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available (Haemophilus influenzae type b) Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Pilot Lot 2) Infant Series


Reporting group description 
Subjects received 1 single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Manufacturing lot) Infant series


Reporting group description 
Subjects received 1 single 0.5 mL dose of 13vPnC manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series; coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
7vPnC Infant series


Reporting group description 
Subjects received 1 single 0.5 mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  



End points reporting groups


Reporting group title 
13vPnC (Pilot Lot 1) Infant Series


Reporting group description 
Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available (Haemophilus influenzae type b) Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Pilot Lot 2) Infant Series


Reporting group description 
Subjects received 1 single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Manufacturing lot) Infant series


Reporting group description 
Subjects received 1 single 0.5 mL dose of 13vPnC manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series; coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
7vPnC Infant series


Reporting group description 
Subjects received 1 single 0.5 mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Pilot Lot 1) After Infant Series


Reporting group description 
Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (in infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Pilot Lot 2) After Infant Series


Reporting group description 
Subjects received single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (in infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Manufacturing lot) After Infant series


Reporting group description 
Subjects received single dose of 13vPnC manu lot at 2, 4, and 6 months of age (in infant series) coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
7vPnC After Infant series


Reporting group description 
Subjects received 1 single 0.5 mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); coadministered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.  
Reporting group title 
13vPnC (Pilot Lot 1) Toddler Dose


Reporting group description 
Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1 at 12 months of age (toddler dose); a commercially available (Measles, Mumps, and Rubellavaricella vaccine) MMRvaricella, or if not available, a commercially available MMR at 12 months of age and a commercially available varicella vaccine administered in separate injections; and a commercially available (hepatitis A vaccine) HAV administered at 12 months of age.  
Reporting group title 
13vPnC (Pilot Lot 2) Toddler dose


Reporting group description 
Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 2 at 12 months of age (toddler dose); a commercially available MMRvaricella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.  
Reporting group title 
13vPnC (Manufacturing lot) Toddler dose


Reporting group description 
Subjects received 1 single 0.5 mL dose of 13vPnC manu lot at 12 months of age (toddler dose); a commercially available MMRvaricella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.  
Reporting group title 
7vPnC Toddler Dose


Reporting group description 
Subjects received 1 single 0.5 mL dose of 7valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose); a commercially available MMRvaricella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.  
Subject analysis set title 
Combined 13vPnC


Subject analysis set type 
Safety analysis  
Subject analysis set description 
Subjects received 1 single 0.5 milliliter (mL) dose of 13valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubellavaricella vaccine (MMRvaricella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.


Subject analysis set title 
13vPnC (Pilot lot 2) Toddler dose


Subject analysis set type 
Safety analysis  
Subject analysis set description 
Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 2 at 12 months of age (toddler dose); a commercially available MMRvaricella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.



End point title 
Geometric Mean Concentration (GMC) for Serotypespecific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series  
End point description 
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes (S) 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw.Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. n=number of subjects with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.


End point type 
Primary


End point timeframe 
1 Month after the infant series (7 Months of age)




Statistical analysis title 
S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
difference in logtransformed GM  
Point estimate 
0.01


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.11  
upper limit 
0.09  
Statistical analysis title 
S4:13vPnC (Pilot Lot 1) vs 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.27


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.38  
upper limit 
0.17  
Statistical analysis title 
S4:13vPnC (Pilot Lot 2) vs.13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.27


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.37  
upper limit 
0.16  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.13  
upper limit 
0.46  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.13


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.04  
upper limit 
0.29  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.17


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.33  
upper limit 
0.01  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.16  
upper limit 
0.04  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.16  
upper limit 
0.04  
Statistical analysis title 
S9v:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
0.1  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.15  
upper limit 
0.09  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.04


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.16  
upper limit 
0.08  
Statistical analysis title 
S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.01


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.13  
upper limit 
0.11  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.13  
upper limit 
0.07  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.13


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.23  
upper limit 
0.03  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
0  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.11


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.22  
upper limit 
0.01  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.22


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.33  
upper limit 
0.11  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.16  
upper limit 
0.11  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.18


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.04  
upper limit 
0.31  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.07  
upper limit 
0.34  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.11


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.23  
upper limit 
0.01  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.16


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.28  
upper limit 
0.04  
Statistical analysis title 
S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.05


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.17  
upper limit 
0.06  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.09


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.19  
upper limit 
0.02  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.18


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.28  
upper limit 
0.07  
Statistical analysis title 
S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.09


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.19  
upper limit 
0.02  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.25


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.13  
upper limit 
0.37  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.12  
upper limit 
0.12  
Statistical analysis title 
S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.25


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.37  
upper limit 
0.13  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.14


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.02  
upper limit 
0.25  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.12


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.01  
upper limit 
0.24  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.01


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.13  
upper limit 
0.11  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.01


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.09  
upper limit 
0.1  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.05


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.14  
upper limit 
0.04  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.15  
upper limit 
0.04  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.08


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.19  
upper limit 
0.03  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.12  
upper limit 
0.09  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.05  
upper limit 
0.17  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than 0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.16  
upper limit 
0.11 


End point title 
Percentage of Subjects Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series  
End point description 
Percentage of subjects achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2sided CI was based on the observed proportion of subjects. Combined 13vPnC group includes subjects randomized to pilot lot 1, pilot lot 2, or the manu lot. Evaluable immunogenicity population. Combined 13vPnC group includes subjects who received pilot lot 1, pilot lot 2, or manu lot.


End point type 
Primary


End point timeframe 
1 month after the infant series (7 months of age)




Statistical analysis title 
Tetanus toxoid  
Statistical analysis description 
Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), noninferiority was shown if the lower limit of the 2sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than 10%.


Comparison groups 
7vPnC After Infant series v Combined 13vPnC


Number of subjects included in analysis 
380


Analysis specification 
Prespecified


Analysis type 
noninferiority  
Method 

Parameter type 
Difference  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.3  
upper limit 
3 


End point title 
Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series  
End point description 
Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2sided CI was based on the observed proportion of subjects. Combined 13vPnC group includes subjects randomized to pilot lot 1, pilot lot 2, or the manufacturing lot. Evaluable immunogenicity population; N=number of subjects analyzed with a determinate postthird dose IgG antibody concentration to the given concomitant vaccine component; n)=number of subjects with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.


End point type 
Primary


End point timeframe 
1 month after the infant series (7 months of age)




Statistical analysis title 
Poliovirus type 1  
Statistical analysis description 
Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), noninferiority was shown if the lower limit of the 2sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than 10%. Exact 2sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.


Comparison groups 
7vPnC After Infant series v Combined 13vPnC


Number of subjects included in analysis 
370


Analysis specification 
Prespecified


Analysis type 
noninferiority  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.1  
upper limit 
2  
Statistical analysis title 
Poliovirus type 2  
Statistical analysis description 
Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), noninferiority was shown if the lower limit of the 2sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than 10%. Exact 2sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.


Comparison groups 
7vPnC After Infant series v Combined 13vPnC


Number of subjects included in analysis 
370


Analysis specification 
Prespecified


Analysis type 
noninferiority  
Method 

Parameter type 
Difference  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.4  
upper limit 
2  
Statistical analysis title 
Poliovirus type 3  
Statistical analysis description 
Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), noninferiority was shown if the lower limit of the 2sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than 10%. Exact 2sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.


Comparison groups 
7vPnC After Infant series v Combined 13vPnC


Number of subjects included in analysis 
370


Analysis specification 
Prespecified


Analysis type 
noninferiority  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.5  
upper limit 
3 


End point title 
Percentage of Subjects Achieving Predefined Antibody Level ≥10.0 MilliInternational Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series  
End point description 
Percentage of subjects achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2sided CI was based on the observed proportion of subjects. Combined 13vPnC group includes subjects randomized to pilot lot 1, pilot lot 2, or the manufacturing lot. Evaluable immunogenicity population; N=number of subjects analyzed with a determinate postthird dose IgG antibody concentration to the given concomitant vaccine component.


End point type 
Primary


End point timeframe 
1 month after the infant series (7 months of age)




Statistical analysis title 
Hepatitis B  
Statistical analysis description 
Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), noninferiority was shown if the lower limit of the 2sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than 10%.Exact 2sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.


Comparison groups 
7vPnC After Infant series v Combined 13vPnC


Number of subjects included in analysis 
326


Analysis specification 
Prespecified


Analysis type 
noninferiority  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.4  
upper limit 
2.2 


End point title 
Percentage of Subjects Achieving Serotypespecific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series  
End point description 
Percentage of subjects achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2sided CI based on the observed proportion of subjects.Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.


End point type 
Secondary


End point timeframe 
1 month after the infant series (7 months of age)




Statistical analysis title 
S4: 13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Pilot Lot 1) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.09  
upper limit 
1.1  
Statistical analysis title 
S4:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.58  
upper limit 
0.58  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
5.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.55  
upper limit 
9.19  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.77  
upper limit 
3.66  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Mau Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
4.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8.82  
upper limit 
1.1  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.13  
upper limit 
2.83  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.97  
upper limit 
1.73  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.81  
upper limit 
1.88  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.27  
upper limit 
1.95  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.6  
upper limit 
3.01  
Statistical analysis title 
S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.04  
upper limit 
2.76  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.38  
upper limit 
4.74  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
1216


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.33  
upper limit 
1.99  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.89  
upper limit 
0.23  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.93  
upper limit 
2.6  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.46  
upper limit 
0.28  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.87  
upper limit 
0.02  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
3.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.03  
upper limit 
7.46  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.27  
upper limit 
8.39  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.75  
upper limit 
5.46  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.48  
upper limit 
3.18  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.78  
upper limit 
1.34  
Statistical analysis title 
S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.77  
upper limit 
0.67  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
3.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.27  
upper limit 
2.45  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
10.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16.8  
upper limit 
4.57  
Statistical analysis title 
S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
6.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.76  
upper limit 
0.74  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
3.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.15  
upper limit 
7.69  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.52  
upper limit 
3.09  
Statistical analysis title 
S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
4.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.92  
upper limit 
0.36  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.12  
upper limit 
5.23  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.22  
upper limit 
1.86  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.39  
upper limit 
0.27  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
1216


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.47  
upper limit 
2.3  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.12  
upper limit 
1.18  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.3  
upper limit 
0.52  
Statistical analysis title 
S19A: 13PnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.91  
upper limit 
0.8  
Statistical analysis title 
S19A: 13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.69  
upper limit 
1.19  
Statistical analysis title 
S19A: 13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
Exact, unconditional 2sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.


Comparison groups 
13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.4  
upper limit 
2.04 


End point title 
Percentage of Subjects Achieving Serotypespecific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose  
End point description 
Percentage of Subjects achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2sided CI based on the observed proportion of Subjects.Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.


End point type 
Secondary


End point timeframe 
1 month after the toddler dose (13 months of age)




Statistical analysis title 
S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots. Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.61  
upper limit 
1.81  
Statistical analysis title 
S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.39  
upper limit 
0.23  
Statistical analysis title 
S4:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.54  
upper limit 
0.2  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.02  
upper limit 
1.11  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.13  
upper limit 
1.06  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.25  
upper limit 
1.37  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.76  
upper limit 
2.18  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.87  
upper limit 
2.18  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.74  
upper limit 
1.62  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.03  
upper limit 
1.04  
Statistical analysis title 
S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.61  
upper limit 
0.76  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.52  
upper limit 
2.39  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.3  
upper limit 
1.04  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.87  
upper limit 
0.74  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.55  
upper limit 
1.5  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.06  
upper limit 
0.57  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.21  
upper limit 
2.05  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.52  
upper limit 
3.16  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.05  
upper limit 
2.87  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.17  
upper limit 
2.53  
Statistical analysis title 
S1:3vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.79  
upper limit 
1.66  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.85  
upper limit 
8.55  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
4.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.99  
upper limit 
0.21  
Statistical analysis title 
S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
7.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.14  
upper limit 
2.37  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1  
upper limit 
1.84  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.27  
upper limit 
1.3  
Statistical analysis title 
S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.84  
upper limit 
1.02  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.04  
upper limit 
1.08  
Statistical analysis title 
S6A13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.76  
upper limit 
1.56  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.83  
upper limit 
1.56  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.47  
upper limit 
2.09  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.48  
upper limit 
2  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.59  
upper limit 
1.49  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
712


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.04  
upper limit 
1.09  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.05  
upper limit 
1.04  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.09  
upper limit 
1.07  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.03  
upper limit 
1.04  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
726


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
2.44  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
702


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.44  
upper limit 
1 


End point title 
Percentage of Subjects Achieving Serotypespecific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series  
End point description 
Percentage of subjects achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2sided CI based on the observed proportion of subjects.Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.


End point type 
Secondary


End point timeframe 
1 month after the infant series (7 months of age)




No statistical analyses for this end point 


End point title 
Percentage of Subjects Achieving Serotypespecific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose  
End point description 
Percentage of subjects achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2sided CI based on the observed proportion of subjects. Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.


End point type 
Secondary


End point timeframe 
1 month after the toddler dose (13 months of age)




Statistical analysis title 
S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.52  
upper limit 
3.63  
Statistical analysis title 
S4: 13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
6.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.3  
upper limit 
2.15  
Statistical analysis title 
S4: 13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
5.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.85  
upper limit 
0.79  
Statistical analysis title 
S6B: 13vPnC (Pilot Lot 2) vs. 13vPnC (Pilot Lot 1)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.19  
upper limit 
2.07  
Statistical analysis title 
S6B: 13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.69  
upper limit 
1.06  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.27  
upper limit 
0.75  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
3.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.46  
upper limit 
1.82  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
4.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.24  
upper limit 
0.76  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.3  
upper limit 
4.41  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.14  
upper limit 
1.73  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.69  
upper limit 
2.39  
Statistical analysis title 
S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.46  
upper limit 
2.59  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
5.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.17  
upper limit 
0.2  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
10


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
15.31  
upper limit 
4.7  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
4.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.55  
upper limit 
0.46  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.23  
upper limit 
2.52  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
3.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.35  
upper limit 
0.4  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.44  
upper limit 
0.33  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.67  
upper limit 
4.8  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.38  
upper limit 
6.28  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.06  
upper limit 
5.82  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.34  
upper limit 
5.08  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.39  
upper limit 
1.18  
Statistical analysis title 
S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
3.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.45  
upper limit 
0.46  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.2  
upper limit 
8.55  
Statistical analysis title 
S3:113vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
4.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.79  
upper limit 
2.16  
Statistical analysis title 
S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
6.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.51  
upper limit 
0.54  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
3.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.84  
upper limit 
7.13  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.14  
upper limit 
4.11  
Statistical analysis title 
S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.72  
upper limit 
1.4  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.87  
upper limit 
3.02  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.62  
upper limit 
1.71  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
0.92  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.62  
upper limit 
4.67  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.67  
upper limit 
1.55  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
2.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.11  
upper limit 
0.01  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.45  
upper limit 
2.1  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
823


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.75  
upper limit 
1.58  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2sided 95% CI on the pairwise difference in proportions; expressed as a percentage.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.86  
upper limit 
1.05 


End point title 
Geometric Mean Concentration (GMC) for Serotypespecific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose  
End point description 
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.


End point type 
Secondary


End point timeframe 
1 month after the toddler dose (13 months of age)




Statistical analysis title 
S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
0.13  
Statistical analysis title 
S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.29


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.41  
upper limit 
0.17  
Statistical analysis title 
S4:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.18  
upper limit 
0.06  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.31


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.41  
upper limit 
0.19  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.18


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.06  
upper limit 
0.3  
Statistical analysis title 
S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.12


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0  
upper limit 
0.23  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.13  
upper limit 
0.09  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.04


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.15  
upper limit 
0.07  
Statistical analysis title 
S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.13  
upper limit 
0.09  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.04


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.17  
upper limit 
0.08  
Statistical analysis title 
S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.11  
upper limit 
0.15  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.12


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.25  
upper limit 
0  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.12


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.25  
upper limit 
0.01  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.18  
upper limit 
0.11  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.37


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.51  
upper limit 
0.22  
Statistical analysis title 
S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.33


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.47  
upper limit 
0.2  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.17  
upper limit 
0.11  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.08


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.07  
upper limit 
0.22  
Statistical analysis title 
S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.11


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.03  
upper limit 
0.25  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.07


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
0.06  
Statistical analysis title 
S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.09


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.21  
upper limit 
0.03  
Statistical analysis title 
S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.15  
upper limit 
0.11  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.06  
upper limit 
0.18  
Statistical analysis title 
S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.07


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.18  
upper limit 
0.04  
Statistical analysis title 
S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.13


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.25  
upper limit 
0.01  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.17


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.05  
upper limit 
0.28  
Statistical analysis title 
S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0  
upper limit 
0.21  
Statistical analysis title 
S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.17  
upper limit 
0.05  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.08


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.04  
upper limit 
0.19  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.02  
upper limit 
0.21  
Statistical analysis title 
S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
0.14  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
0.15  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.05


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.17  
upper limit 
0.07  
Statistical analysis title 
S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.08


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
0.05  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.01


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.11  
upper limit 
0.13  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.14  
upper limit 
0.1  
Statistical analysis title 
S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
803


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.15  
upper limit 
0.08  
Statistical analysis title 
S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose


Number of subjects included in analysis 
817


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.06


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.19  
upper limit 
0.06  
Statistical analysis title 
S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)  
Statistical analysis description 
The 2sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.


Comparison groups 
13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose


Number of subjects included in analysis 
812


Analysis specification 
Prespecified


Analysis type 
equivalence  
Method 

Parameter type 
Difference in logtransformed GM  
Point estimate 
0.24


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.37  
upper limit 
0.12 


End point title 
Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)  
End point description 
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of Subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.


End point type 
Other prespecified


End point timeframe 
Within 7 days after dose 1 (2 months of age)




No statistical analyses for this end point 


End point title 
Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)  
End point description 
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.


End point type 
Other prespecified


End point timeframe 
Within 7 days after dose 2 (4 months of age)




No statistical analyses for this end point 


End point title 
Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)  
End point description 
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.


End point type 
Other prespecified


End point timeframe 
Within 7 days after dose 3 (6 months of age)




No statistical analyses for this end point 


End point title 
Percentage of Subjects Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)  
End point description 
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.


End point type 
Other prespecified


End point timeframe 
Within 7 days after dose (12 months of age)




No statistical analyses for this end point 


End point title 
Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)  
End point description 
Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.


End point type 
Other prespecified


End point timeframe 
Within 7 days after dose 1 (2 months of age)




No statistical analyses for this end point 


End point title 
Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)  
End point description 
Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.


End point type 
Other prespecified


End point timeframe 
Within 7 days after dose 2 (4 months of age)


