Clinical Trial Results:
A Phase II, DoubleBlind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
Summary


EudraCT number 
201600111725 
Trial protocol 
DK ES FI 
Global end of trial date 

Results information


Results version number 
v2(current) 
This version publication date 
16 Feb 2020

First version publication date 
13 Jun 2019

Other versions 
v1 
Version creation reason 
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 
V114008


Additional study identifiers


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


Sponsor organisation name 
Merck Sharp & Dohme Corp.


Sponsor organisation address 
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033


Public contact 
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com


Scientific contact 
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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 
Interim


Date of interim/final analysis 
04 Oct 2018


Is this the analysis of the primary completion data? 
Yes


Primary completion date 
04 Oct 2018


Global end of trial reached? 
No


General information about the trial


Main objective of the trial 
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks ≥42 days to ≤90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific immunoglobulin G (IgG) ≥0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is noninferior to that for recipients of Prevnar 13™.


Protection of trial subjects 
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.


Background therapy 
  
Evidence for comparator 
  
Actual start date of recruitment 
21 Mar 2017


Long term followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
Yes


Population of trial subjects


Number of subjects enrolled per country 

Country: Number of subjects enrolled 
Spain: 68


Country: Number of subjects enrolled 
United States: 689


Country: Number of subjects enrolled 
Canada: 95


Country: Number of subjects enrolled 
Denmark: 55


Country: Number of subjects enrolled 
Finland: 95


Country: Number of subjects enrolled 
Israel: 49


Worldwide total number of subjects 
1051


EEA total number of subjects 
218


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) 
1051


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 
Healthy male and female infants approximately 2 months of age (between 42 and 90 days old) (inclusive) were enrolled in this study other inclusion/exclusion criteria applied.  
Period 1


Period 1 title 
Overall (overall period)


Is this the baseline period? 
Yes  
Allocation method 
Randomised  controlled


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


Are arms mutually exclusive 
Yes


Arm title

V114 Lot 1  
Arm description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Arm type 
Experimental  
Investigational medicinal product name 
V114


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Suspension for injection


Routes of administration 
Intramuscular use


Dosage and administration details 
0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)


Arm title

V114 Lot 2  
Arm description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Arm type 
Experimental  
Investigational medicinal product name 
V114


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Suspension for injection


Routes of administration 
Intramuscular use


Dosage and administration details 
0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)


Arm title

Prevnar 13™  
Arm description 
Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Arm type 
Active comparator  
Investigational medicinal product name 
Prevnar 13™


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Suspension for injection


Routes of administration 
Intramuscular use


Dosage and administration details 
0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)





Baseline characteristics reporting groups


Reporting group title 
V114 Lot 1


Reporting group description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Reporting group title 
V114 Lot 2


Reporting group description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Reporting group title 
Prevnar 13™


Reporting group description 
Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  



End points reporting groups


Reporting group title 
V114 Lot 1


Reporting group description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Reporting group title 
V114 Lot 2


Reporting group description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Reporting group title 
Prevnar 13™


Reporting group description 
Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Subject analysis set title 
V114 Lot 1Immunogenicity


Subject analysis set type 
Per protocol  
Subject analysis set description 
All participants who were not considered as protocol violators and had data available for the endpoint. Violations include but are not limited to: failure to receive the scheduled doses (at least 28 days between doses 1 and 2 and between doses 2 and 3, and dose 4 at 12 months to 15 months of age) of correct clinical material, and lack of valid serology results available from 28 to 42 days following the dose being analyzed.


Subject analysis set title 
V114 Lot 2Immunogenicity


Subject analysis set type 
Per protocol  
Subject analysis set description 
All participants who were not considered as protocol violators and had data available for the endpoint. Violations include but are not limited to: failure to receive the scheduled doses (at least 28 days between doses 1 and 2 and between doses 2 and 3, and dose 4 at 12 months to 15 months of age) of correct clinical material, and lack of valid serology results available from 28 to 42 days following the dose being analyzed.


Subject analysis set title 
Prevnar 13™Immunogenicity


Subject analysis set type 
Per protocol  
Subject analysis set description 
All participants who were not considered as protocol violators and had data available for the endpoint. Violations include but are not limited to: failure to receive the scheduled doses (at least 28 days between doses 1 and 2 and between doses 2 and 3, and dose 4 at 12 months to 15 months of age) of correct clinical material, and lack of valid serology results available from 28 to 42 days following the dose being analyzed.


Subject analysis set title 
V114 Lot 1Safety


Subject analysis set type 
Safety analysis  
Subject analysis set description 
All participants that received at least 1 vaccination and had data available for endpoint.


Subject analysis set title 
V114 Lot 2Safety


Subject analysis set type 
Safety analysis  
Subject analysis set description 
All participants that received at least 1 vaccination and had data available for endpoint.


Subject analysis set title 
Prevnar 13™Safety


Subject analysis set type 
Safety analysis  
Subject analysis set description 
All participants that received at least 1 vaccination and had data available for endpoint.



End point title 
Percentage of Participants Achieving the Serotypespecific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3  
End point description 
Serotypespecific pneumococcal IgG antibody was measured using the MesoScale Discovery (MSD) Pnelectrochemiluminescence assay (Pn ECL). The percentage of participants with serotypespecific IgG ≥0.35 µg/mL was summarized for each serotype.


End point type 
Primary


End point timeframe 
1 month post vaccination 3 (Month 5)




Notes [1]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [2]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [3]  Includes Perprotocol participants with data for endpoint; n's vary with serotype 

Statistical analysis title 
Type 1: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[4]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.3  
upper limit 
3  
Notes [4]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 3: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[5]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
24.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.7  
upper limit 
30  
Notes [5]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 4: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[6]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0  
upper limit 
6.4  
Notes [6]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 5: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[7]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.9  
upper limit 
2.8  
Notes [7]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 6A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[8]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
5.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10  
upper limit 
1.6  
Notes [8]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 6B: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[9]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.7  
upper limit 
4  
Notes [9]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 7F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[10]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Differences in percentages  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.1  
upper limit 
2.7  
Notes [10]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 9V: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[11]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
1.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.9  
upper limit 
4.6  
Notes [11]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 14: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[12]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
4.7  
Notes [12]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 18C: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[13]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
1.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.1  
upper limit 
4.7  
Notes [13]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 19A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[14]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.9  
upper limit 
2.6  
Notes [14]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 19F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[15]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1  
upper limit 
1.9  
Notes [15]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 23F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[16]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
1.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.9  
upper limit 
6.5  
Notes [16]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 1: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[17]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2  
upper limit 
3.9  
Notes [17]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 3: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[18]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
22.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16.5  
upper limit 
28.3  
Notes [18]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 4: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[19]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.4  
upper limit 
5.4  
Notes [19]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 5: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[20]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.1  
upper limit 
2.7  
Notes [20]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 6A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[21]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.2  
upper limit 
2.8  
Notes [21]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 6B: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[22]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.7  
upper limit 
5.6  
Notes [22]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 7F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[23]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.7  
upper limit 
2.4  
Notes [23]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 9V: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[24]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.1  
upper limit 
5.2  
Notes [24]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 14: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[25]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.8  
upper limit 
3.1  
Notes [25]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 18C: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[26]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
2.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.3  
upper limit 
5.9  
Notes [26]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 19A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[27]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.5  
upper limit 
2.2  
Notes [27]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 19F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[28]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.9  
upper limit 
0.9  
Notes [28]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 

Statistical analysis title 
Type 23F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[29]}  
Pvalue 
< 0.001  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
4.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
8.7  
Notes [29]  Statistical criterion for noninferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than 0.15 for each of the 13 shared serotypes. 


End point title 
Geometric Mean Concentration of Serotypespecific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3  
End point description 
Serotypespecific pneumococcal IgG antibody will be assayed using the MesoScale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration of serotypespecific IgG will be assessed.


End point type 
Primary


End point timeframe 
1 month post Vaccination 3 (Month 5)




Notes [30]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [31]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [32]  Includes Perprotocol participants with data for endpoint; n's vary with serotype 

Statistical analysis title 
GMC RatioType 1: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.72


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.64  
upper limit 
0.81  
Statistical analysis title 
GMC RatioType 3: Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.98


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.75  
upper limit 
2.23  
Statistical analysis title 
GMC RatioType 4: Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.04


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.92  
upper limit 
1.16  
Statistical analysis title 
GMC RatioType 5: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.78


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.68  
upper limit 
0.89  
Statistical analysis title 
GMC RatioType 6A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.54


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.47  
upper limit 
0.63  
Statistical analysis title 
GMC Ratio Type 6B: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.03


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.84  
upper limit 
1.26  
Statistical analysis title 
GMC RatioType 7F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.82


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.73  
upper limit 
0.92  
Statistical analysis title 
GMC RatioType 9V: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.88


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.77  
upper limit 
1  
Statistical analysis title 
GMC RatioType 14: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.88


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.75  
upper limit 
1.03  
Statistical analysis title 
GMC RatioType 18C: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.75


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.66  
upper limit 
0.84  
Statistical analysis title 
GMC RatioType 23F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.98


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.84  
upper limit 
1.13  
Statistical analysis title 
GMC RatioType 22F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
92.05


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
80.84  
upper limit 
104.81  
Statistical analysis title 
GMC RatioType 33F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
34.41


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
28.5  
upper limit 
41.54  
Statistical analysis title 
GMC RatioType 1: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.83


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.74  
upper limit 
0.94  
Statistical analysis title 
GMC RatioType 3: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.93


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.71  
upper limit 
2.18  
Statistical analysis title 
GMC RatioType 4: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.01


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.9  
upper limit 
1.14  
Statistical analysis title 
GMC RatioType 5: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.83


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.72  
upper limit 
0.94  
Statistical analysis title 
GMC RatioType 6A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.57


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.49  
upper limit 
0.66  
Statistical analysis title 
GMC RatioType 6B: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.74  
upper limit 
1.1  
Statistical analysis title 
GMC RatioType 7F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.81


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.72  
upper limit 
0.91  
Statistical analysis title 
GMC RatioType 9V: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.07


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.94  
upper limit 
1.22  
Statistical analysis title 
GMC RatioType 14: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.83


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.71  
upper limit 
0.97  
Statistical analysis title 
GMC RatioType 18C: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.99


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.88  
upper limit 
1.12  
Statistical analysis title 
GMC RatioType 23F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.18


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.01  
upper limit 
1.37  
Statistical analysis title 
GMC RatioType 19F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.91


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.81  
upper limit 
1.01  
Statistical analysis title 
GMC RatioType 22F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
80.09


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
70.3  
upper limit 
91.24  
Statistical analysis title 
GMC RatioType 33F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
32.92


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
27.25  
upper limit 
39.78  
Statistical analysis title 
GMC RatioType 19F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.88


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.79  
upper limit 
0.98  
Statistical analysis title 
GMC RatioType 19A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
569


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.82


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.73  
upper limit 
0.92  
Statistical analysis title 
GMC RatioType 19A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
564


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.82


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.73  
upper limit 
0.92 


End point title 
Percentage of Participants Who Experience at Least 1 Adverse Event  
End point description 
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocolspecified procedure, whether or not considered related to the medicinal product or protocolspecified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The percentage of participants with one or more AEs was assessed.


End point type 
Primary


End point timeframe 
Up to 1 month post Vaccination 4 (up to 14 months)




Statistical analysis title 
V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 1Safety v Prevnar 13™Safety


Number of subjects included in analysis 
697


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference in Percentages  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.1  
upper limit 
3.2  
Statistical analysis title 
V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 2Safety v Prevnar 13™Safety


Number of subjects included in analysis 
694


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference in Percentages  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.7  
upper limit 
5 


End point title 
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event  
End point description 
The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.


End point type 
Primary


End point timeframe 
Up to 1 month post Vaccination 4 (up to 14 months)




Statistical analysis title 
V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 2Safety v Prevnar 13™Safety


Number of subjects included in analysis 
694


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference in Percentages  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.8  
upper limit 
1.6  
Statistical analysis title 
V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 1Safety v Prevnar 13™Safety


Number of subjects included in analysis 
697


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
Difference in Perentages  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.8  
upper limit 
1.6 


End point title 
Percentage of Participants with a Solicited Injectionsite Adverse Event  
End point description 
Injectionsite AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injectionsite AEs was assessed


End point type 
Primary


End point timeframe 
Up to 14 days post any vaccination




Statistical analysis title 
V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 1Safety v Prevnar 13™Safety


Number of subjects included in analysis 
697


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
= 0.062  
Method 
Miettinen & Nurminen  
Parameter type 
Difference in percentages  
Point estimate 
6.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.3  
upper limit 
12.8  
Statistical analysis title 
V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 2Safety v Prevnar 13™Safety


Number of subjects included in analysis 
694


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
= 0.059  
Method 
Miettinen & Nurminen  
Parameter type 
Difference in percentages  
Point estimate 
6.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
12.9 


End point title 
Percentage of Participants with a Solicited Systemic Adverse Event  
End point description 
Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.


End point type 
Primary


End point timeframe 
Up to 14 days post any vaccination




Statistical analysis title 
V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 1Safety v Prevnar 13™Safety


Number of subjects included in analysis 
697


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
= 0.772  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.9  
upper limit 
5.2  
Statistical analysis title 
V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.


Comparison groups 
V114 Lot 2Safety v Prevnar 13™Safety


Number of subjects included in analysis 
694


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
= 0.235  
Method 
Miettinen and Nurminen  
Parameter type 
Difference in Percentages  
Point estimate 
2.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.7  
upper limit 
7 


End point title 
Geometric Mean Concentration of Serotypespecific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4  
End point description 
Serotypespecific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.


End point type 
Secondary


End point timeframe 
1 month post vaccination 4 (Month 1114)




Notes [33]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [34]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [35]  Includes Perprotocol participants with data for endpoint; n's vary with serotype 

Statistical analysis title 
GMC RatioType 1: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
Prevnar 13™Immunogenicity v V114 Lot 1Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.71


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.62  
upper limit 
0.81  
Statistical analysis title 
GMC RatioType 3: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.44


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.27  
upper limit 
1.63  
Statistical analysis title 
GMC RatioType 4: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.88


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.76  
upper limit 
1.02  
Statistical analysis title 
GMC RatioType 5: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.73


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.63  
upper limit 
0.84  
Statistical analysis title 
GMC RatioType 6A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.72


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.62  
upper limit 
0.82  
Statistical analysis title 
GMC RatioType 6B: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.07


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.93  
upper limit 
1.22  
Statistical analysis title 
GMC RatioType 7F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.67


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.59  
upper limit 
0.77  
Statistical analysis title 
GMC RatioType 9V: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.69


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.6  
upper limit 
0.79  
Statistical analysis title 
GMC RatioType 14: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.88


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.76  
upper limit 
1.02  
Statistical analysis title 
GMC RatioType 18C: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.93


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.81  
upper limit 
1.08  
Statistical analysis title 
GMC RatioType 19F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.97


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.85  
upper limit 
1.1  
Statistical analysis title 
GMC RatioType 19A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.89


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.78  
upper limit 
1.01  
Statistical analysis title 
GMC RatioType 23F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.75


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.64  
upper limit 
0.87  
Statistical analysis title 
GMC RatioType 22F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
149.69


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
130.23  
upper limit 
172.06  
Statistical analysis title 
GMC RatioType 33F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
550


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
90.35


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
79.93  
upper limit 
102.12  
Statistical analysis title 
GMC RatioType 1: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.81


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.71  
upper limit 
0.93  
Statistical analysis title 
GMC RatioType 3: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.48


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.31  
upper limit 
1.68  
Statistical analysis title 
GMC RatioType 4: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.81


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.7  
upper limit 
0.94  
Statistical analysis title 
GMC RatioType 5: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.69


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.6  
upper limit 
0.79  
Statistical analysis title 
GMC RatioType 6A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.66


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.58  
upper limit 
0.76  
Statistical analysis title 
GMC RatioType 6B: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.83


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.72  
upper limit 
0.95  
Statistical analysis title 
GMC RatioType 9V: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.77


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.67  
upper limit 
0.88  
Statistical analysis title 
GMC RatioType 7F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.71


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.62  
upper limit 
0.81  
Statistical analysis title 
GMC RatioType 18C: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.07


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.93  
upper limit 
1.24  
Statistical analysis title 
GMC RatioType 14: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.85


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.73  
upper limit 
0.98  
Statistical analysis title 
GMC RatioType 19A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.82


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.72  
upper limit 
0.93  
Statistical analysis title 
GMC RatioType 19F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.79  
upper limit 
1.03  
Statistical analysis title 
GMC RatioType 22F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
131.23


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
114.05  
upper limit 
151  
Statistical analysis title 
GMC RatioType 23F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.92


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.79  
upper limit 
1.08  
Statistical analysis title 
GMC RatioType 33F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
542


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
78.99


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
69.82  
upper limit 
89.36 


End point title 
Geometric Mean Concentration of Serotypespecific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Prevaccination 4  
End point description 
Serotypespecific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.


End point type 
Secondary


End point timeframe 
Before Vaccination 4 (Month 10 to 13)




Notes [36]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [37]  Includes Perprotocol participants with data for endpoint; n's vary with serotype [38]  Includes Perprotocol participants with data for endpoint; n's vary with serotype 

Statistical analysis title 
GMC RatioType 1: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.69


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.62  
upper limit 
0.76  
Statistical analysis title 
GMC RatioType 3: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.75  
upper limit 
2.28  
Statistical analysis title 
GMC RatioType 4: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.96


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.86  
upper limit 
1.07  
Statistical analysis title 
GMC RatioType 5: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.87


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.78  
upper limit 
0.96  
Statistical analysis title 
GMC RatioType 6A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.57


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.5  
upper limit 
0.65  
Statistical analysis title 
GMC RatioType 6B: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.21


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.06  
upper limit 
1.39  
Statistical analysis title 
GMC RatioType 7F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.74


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.67  
upper limit 
0.82  
Statistical analysis title 
GMC RatioType 9V: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.84


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.74  
upper limit 
0.95  
Statistical analysis title 
GMC RatioType 14: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.66


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.58  
upper limit 
0.76  
Statistical analysis title 
GMC RatioType 18C: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.72  
upper limit 
0.9  
Statistical analysis title 
GMC RatioType 19A: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.79


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.69  
upper limit 
0.91  
Statistical analysis title 
GMC RatioType 19F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.74


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.65  
upper limit 
0.85  
Statistical analysis title 
GMC RatioType 23F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.92


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.79  
upper limit 
1.07  
Statistical analysis title 
GMC RatioType 22F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
27.82


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.64  
upper limit 
31.4  
Statistical analysis title 
GMC RatioType 33F: V114 Lot 1 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 1Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
567


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
25.57


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
22.61  
upper limit 
28.92  
Statistical analysis title 
GMC RatioType 1: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC ratio  
Point estimate 
0.77


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.69  
upper limit 
0.85  
Statistical analysis title 
GMC RatioType 3: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
2.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.84  
upper limit 
2.39  
Statistical analysis title 
GMC RatioType 4: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.94


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.85  
upper limit 
1.05  
Statistical analysis title 
GMC RatioType 5: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.86


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.77  
upper limit 
0.95  
Statistical analysis title 
GMC RatioType 6A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.65


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.57  
upper limit 
0.74  
Statistical analysis title 
GMC RatioType 6B: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.12


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.97  
upper limit 
1.28  
Statistical analysis title 
GMC RatioType 7F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.78


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.7  
upper limit 
0.86  
Statistical analysis title 
GMC RatioType 9V: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.86


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.76  
upper limit 
0.97  
Statistical analysis title 
GMC RatioType 18C: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.07  
upper limit 
1.34  
Statistical analysis title 
GMC RatioType 14: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.61


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.53  
upper limit 
0.7  
Statistical analysis title 
GMC RatioType 19A: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.82


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.71  
upper limit 
0.94  
Statistical analysis title 
GMC RatioType 19F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
0.83


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.73  
upper limit 
0.94  
Statistical analysis title 
GMC RatioType 22F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
26.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.31  
upper limit 
29.68  
Statistical analysis title 
GMC RatioType 23F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
1.16


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.99  
upper limit 
1.35  
Statistical analysis title 
GMC RatioType 33F: V114 Lot 2 versus Prevnar 13â„¢  
Statistical analysis description 
IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with logtransformed IgG antibody responses as response variable and vaccination group as covariate.


Comparison groups 
V114 Lot 2Immunogenicity v Prevnar 13™Immunogenicity


Number of subjects included in analysis 
570


Analysis specification 
Prespecified


Analysis type 
other  
Method 

Parameter type 
GMC Ratio  
Point estimate 
24.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
21.32  
upper limit 
27.25 


Adverse events information


Timeframe for reporting adverse events 
Up to approximately 1month (28 to 42 days) post Vaccination 4 (up to 15 months)


Adverse event reporting additional description 
All enrolled participants that received at least 1 vaccination


Assessment type 
Systematic  
Dictionary used for adverse event reporting


Dictionary name 
MedDRA  
Dictionary version 
22.0


Reporting groups


Reporting group title 
V114 Lot 1


Reporting group description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Reporting group title 
V114 Lot 2


Reporting group description 
Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  
Reporting group title 
Prevnar 13™


Reporting group description 
Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 1215 months of age (Study Day 1, Month 2, Month 4, and Month 1013)  


Frequency threshold for reporting nonserious adverse events: 5%  



Substantial protocol amendments (globally) 

Were there any global substantial amendments to the protocol? Yes  
Date 
Amendment 

24 May 2018 
Amendment 1: Primary reason for the amendment was to remove the exploratory biomarker section. Other changes included removing 2 nonpertinent immunogenicity outcomes. 

Interruptions (globally) 

Were there any global interruptions to the trial? No  
Limitations and caveats 

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.  
None reported 