Clinical Trial Results:
A phase III, randomized, multinational study, double-blinded for the immunogenicity and consistency evaluation of 3 Hib-MenCY-TT vaccine lots and single-blinded and controlled for the evaluation of safety and immunogenicity of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (Hib-MenCY-TT) compared to monovalent Hib vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age.
Summary
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EudraCT number |
2005-002352-18 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
26 Feb 2008
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Results information
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Results version number |
v2 |
This version publication date |
06 Aug 2016
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First version publication date |
02 Jul 2015
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Other versions |
v1 , v3 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
103813,105067
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00289783 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Apr 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Aug 2007
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Feb 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate: the lot-to-lot consistency of 3 lots of Hib-MenCY-TT co-administered with DTPa-HBV-IPV following 3 doses, in terms of PRP, MenC and MenY; the immune response to PRP in the group that received 3 doses of Hib-MenCY-TT and a 4th dose of Hib-MenCY-TT was non-inferior to the group that received Hib and Hib-OMP. To evaluate the immunogenicity of a 4th dose of Hib-MenCY-TT co-administered with DTPa-HBV-IPV, MMR and Var. To evaluate the effect of a 4th dose of Hib-MenCY-TT co-administered with MMR and Var, in terms of a vaccine response; the non-inferiority of Hib-MenCY-TT compared to Hib, co-administered with DTPa-HBV-IPV, in terms of PRP; the non-inferiority of MMR when co-administered with a 4th dose of Hib-MenCY-TT compared to MMR co-administered with a 4th dose of Hib-OMP, co-administered with Var; the non-inferiority of Var co-administered with a 4th dose of Hib-MenCY-TT compared to Var co-administered with a 4th dose of Hib-OMP, co-administered with MMR.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Feb 2006
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 3037
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Country: Number of subjects enrolled |
Australia: 604
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Country: Number of subjects enrolled |
Mexico: 800
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Worldwide total number of subjects |
4441
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
4441
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were randomized at the beginning of the primary phase and kept their group assignment during the fourth dose vaccination phase. The study protocol identified 3 different study cohorts : United States (US) Safety and Immunogenicity (Cohort 1), Safety Only (Cohort 2: from all investigation sites), Non-US Safety and Immunogenicity (Cohort 3). | |||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
The data for 261 subjects from one study center in the US were not included in the analyses as vaccine accountability could not be fully reconciled (i.e. treatment group assignment for the different subjects could not be verified). | |||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer | |||||||||||||||||||||||||||||||||
Blinding implementation details |
Double-blind for the immunogenicity and consistency evaluation of the 3 Hib-MenCY-TT vaccine lots and single-blind and controlled for the evaluation of safety and immunogenicity of Hib-MenCY-TT compared to monovalent Hib vaccine, randomized study with 4 parallel treatment groups (1:1:1:1).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Menhibrix Group | |||||||||||||||||||||||||||||||||
Arm description |
Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GSK Biologicals’ Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3-doses administered at 2, 4 and 6 months of age, and 1 booster dose at 12 to 15 months of age.The vaccines were administered intramuscularly in the right upper thigh.
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Investigational medicinal product name |
Pediarix
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Investigational medicinal product code |
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Other name |
Infanrix penta
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
A 3-dose injection at 2, 4 and 6 months of age, administered intramuscularly in the left upper thigh.
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Investigational medicinal product name |
Prevnar
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
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Investigational medicinal product name |
M-M-R II
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
1 booster dose by subcutaneous injection at 12 to 15 months of age.
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Investigational medicinal product name |
Varivax
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
1 booster dose by subcutaneous injection at 12 to 15 months of age
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Arm title
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ActHIB Group | |||||||||||||||||||||||||||||||||
Arm description |
Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | |||||||||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
ActHIB
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3-dose injection administered at 2, 4 and 6 months of age, intramuscularly in the right upper thigh.
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Investigational medicinal product name |
PedvaxHIB
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
1 booster dose by intramuscular injection at 12 to 15 months of age, administered in the left lower deltoid or tight
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The data for 261 subjects from one study center in the US were not included in the analyses as vaccine accountability could not be fully reconciled (i.e. treatment group assignment for the different subjects could not be verified). |
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Baseline characteristics reporting groups
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Reporting group title |
Menhibrix Group
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Reporting group description |
Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ActHIB Group
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Reporting group description |
Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Menhibrix Group
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Reporting group description |
Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | ||
Reporting group title |
ActHIB Group
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Reporting group description |
Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | ||
Subject analysis set title |
Menhibrix A Group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
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Subject analysis set title |
Menhibrix B Group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
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Subject analysis set title |
Menhibrix C Group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
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End point title |
Anti-Polyribosyl Ribitol Phosphate (PRP) antibody concentrations | ||||||||||||||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
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End point type |
Primary
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End point timeframe |
One month after primary vaccination
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Statistical analysis title |
GMC ratio anti-PRP LotB / LotA | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.
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Comparison groups |
Menhibrix A Group v Menhibrix B Group
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Number of subjects included in analysis |
342
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||||||||||||||||||||
Method |
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Parameter type |
GMC ratio | ||||||||||||||||||||||||||||||
Point estimate |
1.12
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.89 | ||||||||||||||||||||||||||||||
upper limit |
1.42 | ||||||||||||||||||||||||||||||
Notes [1] - Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the [0.5; 2.0] interval. |
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Statistical analysis title |
GMC ratio anti-PRP LotC / LotA | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.
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Comparison groups |
Menhibrix A Group v Menhibrix C Group
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Number of subjects included in analysis |
338
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||||||||||||||||||||
Method |
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Parameter type |
GMC ratio | ||||||||||||||||||||||||||||||
Point estimate |
1.12
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.89 | ||||||||||||||||||||||||||||||
upper limit |
1.42 | ||||||||||||||||||||||||||||||
Notes [2] - Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the [0.5; 2.0] interval. |
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Statistical analysis title |
GMC ratio anti-PRP LotC / LotB | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.
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Comparison groups |
Menhibrix B Group v Menhibrix C Group
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Number of subjects included in analysis |
356
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||||||||||||||||||||
Method |
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Parameter type |
GMC ratio | ||||||||||||||||||||||||||||||
Point estimate |
1
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.8 | ||||||||||||||||||||||||||||||
upper limit |
1.26 | ||||||||||||||||||||||||||||||
Notes [3] - Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the [0.5; 2.0] interval. |
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End point title |
Neisseria meningitidis serogroup C (MenC) serum bactericidal assay using human complement (hSBA) antibody titers | ||||||||||||||||||||||||||||||
End point description |
Titers were expressed as Geometric Mean Titers (GMTs). This analysis occured on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
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End point type |
Primary
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End point timeframe |
One month after primary vaccination
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Statistical analysis title |
GMT ratio hSBA-MenC Lot B/Lot A | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).
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Comparison groups |
Menhibrix A Group v Menhibrix B Group
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Number of subjects included in analysis |
326
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Analysis specification |
Pre-specified
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Analysis type |
other [4] | ||||||||||||||||||||||||||||||
Method |
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Parameter type |
GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
1.23
|
||||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||||
lower limit |
0.93 | ||||||||||||||||||||||||||||||
upper limit |
1.62 | ||||||||||||||||||||||||||||||
Notes [4] - For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval. |
|||||||||||||||||||||||||||||||
Statistical analysis title |
GMT ratio hSBA-MenC Lot C/Lot A | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).
|
||||||||||||||||||||||||||||||
Comparison groups |
Menhibrix C Group v Menhibrix A Group
|
||||||||||||||||||||||||||||||
Number of subjects included in analysis |
323
|
||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||||
Analysis type |
other [5] | ||||||||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
0.97
|
||||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||||
lower limit |
0.74 | ||||||||||||||||||||||||||||||
upper limit |
1.29 | ||||||||||||||||||||||||||||||
Notes [5] - For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval. |
|||||||||||||||||||||||||||||||
Statistical analysis title |
GMT ratio hSBA-MenC Lot C/Lot B | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).
|
||||||||||||||||||||||||||||||
Comparison groups |
Menhibrix B Group v Menhibrix C Group
|
||||||||||||||||||||||||||||||
Number of subjects included in analysis |
333
|
||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||||
Analysis type |
other [6] | ||||||||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
0.79
|
||||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||||
lower limit |
0.6 | ||||||||||||||||||||||||||||||
upper limit |
1.04 | ||||||||||||||||||||||||||||||
Notes [6] - For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval. |
|
|||||||||||||||||||||||||||||||
End point title |
Neisseria meningitidis serogroup Y (MenY) serum bactericidal assay using human complement (hSBA) antibody titers | ||||||||||||||||||||||||||||||
End point description |
Titers are expressen as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Statistical analysis title |
GMT ratio hSBA-MenY Lot B/Lot A | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).
|
||||||||||||||||||||||||||||||
Comparison groups |
Menhibrix A Group v Menhibrix B Group
|
||||||||||||||||||||||||||||||
Number of subjects included in analysis |
318
|
||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||||
Analysis type |
other [7] | ||||||||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
1.61
|
||||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||||
lower limit |
1.14 | ||||||||||||||||||||||||||||||
upper limit |
2.27 | ||||||||||||||||||||||||||||||
Notes [7] - For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval. |
|||||||||||||||||||||||||||||||
Statistical analysis title |
GMT ratio hSBA-MenY Lot C/Lot A | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).
|
||||||||||||||||||||||||||||||
Comparison groups |
Menhibrix A Group v Menhibrix C Group
|
||||||||||||||||||||||||||||||
Number of subjects included in analysis |
313
|
||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||||
Analysis type |
other [8] | ||||||||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
1.4
|
||||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||||
lower limit |
0.99 | ||||||||||||||||||||||||||||||
upper limit |
1.97 | ||||||||||||||||||||||||||||||
Notes [8] - For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval. |
|||||||||||||||||||||||||||||||
Statistical analysis title |
GMT ratio hSBA-MenC Lot C/Lot B | ||||||||||||||||||||||||||||||
Statistical analysis description |
To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).
|
||||||||||||||||||||||||||||||
Comparison groups |
Menhibrix B Group v Menhibrix C Group
|
||||||||||||||||||||||||||||||
Number of subjects included in analysis |
331
|
||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||||
Analysis type |
other [9] | ||||||||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
0.87
|
||||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||||
lower limit |
0.62 | ||||||||||||||||||||||||||||||
upper limit |
1.21 | ||||||||||||||||||||||||||||||
Notes [9] - For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval. |
|
|||||||||||||||||||
End point title |
hSBA-MenC antibody titers | ||||||||||||||||||
End point description |
Titers are expressed as Geometric Mean Titers (GMTs). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and 42 days after the fourth dose
|
||||||||||||||||||
|
|||||||||||||||||||
Statistical analysis title |
1.hSBA-MenC GMT ratio - Post-dose 4/Pre-dose 4 | ||||||||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||||||||
Number of subjects included in analysis |
450
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
12
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
10.4 | ||||||||||||||||||
upper limit |
13.8 | ||||||||||||||||||
Statistical analysis title |
2.hSBA-MenC GMT ratio - Post-dose 4/Pre-dose 4 | ||||||||||||||||||
Statistical analysis description |
Note:
Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values).
|
||||||||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||||||||
Number of subjects included in analysis |
450
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
1.4
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
1.4 | ||||||||||||||||||
upper limit |
1.4 |
|
|||||||||||||||||||
End point title |
hSBA-MenY antibody titers | ||||||||||||||||||
End point description |
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and 42 days after the fourth dose
|
||||||||||||||||||
|
|||||||||||||||||||
Statistical analysis title |
1.hSBA-MenY GMT ratio - Post-dose 4/Pre-dose 4 | ||||||||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||||||||
Number of subjects included in analysis |
462
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
11.8
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
10.2 | ||||||||||||||||||
upper limit |
13.8 | ||||||||||||||||||
Statistical analysis title |
2.hSBA-MenY GMT ratio - Post-dose 4/Pre-dose 4 | ||||||||||||||||||
Comparison groups |
ActHIB Group v Menhibrix Group
|
||||||||||||||||||
Number of subjects included in analysis |
462
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
21.1
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
21.1 | ||||||||||||||||||
upper limit |
21.1 |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with anti-PRP antibody concentration equal to or above 1.0 microgram per milliliter (µg/mL) [10] | ||||||||||||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
||||||||||||||||||||||||
Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with hSBA-MenC titer equal to or above 1:8 [11] | ||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
42 days after the fourth dose
|
||||||||||||
Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with hSBA-MenY titer equal to or above 1:8 [12] | ||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
42 days after the fourth dose
|
||||||||||||
Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with anti-measles antibody concentrations equal to or above 150 milli-international units per milliliter (mIU/mL) | ||||||||||||
End point description |
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
42 days after the fourth dose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Serostatus for anti-measles antibodies | ||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||
Number of subjects included in analysis |
1138
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
non-inferiority | ||||||||||||
Method |
|||||||||||||
Parameter type |
Difference in percentage | ||||||||||||
Point estimate |
-0.15
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.56 | ||||||||||||
upper limit |
3.06 |
|
|||||||||||||
End point title |
Number of subjects with anti-PRP antibody concentration equal to or above 1.0 microgram per milliliter | ||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
42 days after the fourth dose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Serostatus for anti-PRP | ||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||
Number of subjects included in analysis |
487
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
non-inferiority | ||||||||||||
Method |
|||||||||||||
Parameter type |
Difference in percentage | ||||||||||||
Point estimate |
-0.04
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.78 | ||||||||||||
upper limit |
3.57 |
|
|||||||||||||
End point title |
Number of subjects with anti-mumps titer equal to or above 28 estimated dose 50 (ED50) | ||||||||||||
End point description |
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50. Co-administration with MMR-II vaccine.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
42 days after the fourth dose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Serostatus for anti-mumps antibodies ≥ 28 ED50 | ||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||
Number of subjects included in analysis |
792
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
non-inferiority | ||||||||||||
Method |
|||||||||||||
Parameter type |
Difference in percentage | ||||||||||||
Point estimate |
-1
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.16 | ||||||||||||
upper limit |
0.98 |
|
|||||||||||||
End point title |
Number of subjects with anti-rubella antibody concentrations equal to or above 10 international units per millilitre (IU/mL) | ||||||||||||
End point description |
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
42 days after the fourth dose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Serostatus for anti-rubella antibodies ≥ 10 IU/mL | ||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||
Number of subjects included in analysis |
1135
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
non-inferiority | ||||||||||||
Method |
|||||||||||||
Parameter type |
Difference in percentage | ||||||||||||
Point estimate |
0.12
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.57 | ||||||||||||
upper limit |
1.73 |
|
|||||||||||||
End point title |
Number of subjects with anti-varicella titers equal to or above 1:5 | ||||||||||||
End point description |
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5. Co-administration with Varivax vaccine.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
42 days after the fourth dose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Serostatus for anti-varicella antibodies (≥ 1:5) | ||||||||||||
Comparison groups |
Menhibrix Group v ActHIB Group
|
||||||||||||
Number of subjects included in analysis |
946
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
non-inferiority | ||||||||||||
Method |
|||||||||||||
Parameter type |
Difference in percentage | ||||||||||||
Point estimate |
-0.14
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.78 | ||||||||||||
upper limit |
1.56 |
|
||||||||||||||||
End point title |
Number of subjects with anti-tetanus (anti-T) and anti-diphtheria toxoid (anti-D) antibody concentrations equal to or above 0.1 international units per millilitre (IU/mL) | |||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after primary vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-D and anti-T antibody concentrations | ||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with anti hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above 10.0 milli-international units per millilitre (mIU/mL) | |||||||||||||||
End point description |
Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after primary vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-HBs antibody concentrations | ||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL) Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations equal to or above 5 ELISA units per millilitre (EL.U/mL) | ||||||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Anti-PT, anti-FHA and anti-PRN antibody concentrations | |||||||||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects with anti-poliovirus types 1, 2 and 3 equal to or above 8 estimated dose 50 (ED50) | ||||||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Anti-poliovirus types 1, 2 and 3 titers | |||||||||||||||||||||
End point description |
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with antibodies to Neisseria meningitidis serogroup C and Y polysaccharide capsule (anti-PSC and anti-PSY) concentrations equal to or above the cut-off values | |||||||||||||||||||||
End point description |
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-PSC and anti-PSY antibody concentrations | ||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after primary vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PRP antibody concentrations equal to or above the cut-off values | ||||||||||||||||||||||||||||||
End point description |
Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with anti-PRP antibody concentrations equal to or above the cut-off values | |||||||||||||||||||||
End point description |
Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and one month after fourth dose vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Anti-PRP antibody concentrations | ||||||||||||||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-PRP antibody concentrations | ||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and one month after fourth dose vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenC and hSBA-MenY titers equal to or above the cut-off values | ||||||||||||||||||||||||||||||||||||||||||
End point description |
hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenC and hSBA-MenY titers equal to or above the cut-off values | |||||||||||||||||||||||||||||||||
End point description |
hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and one month after fourth dose vaccination
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
hSBA-MenC and hSBA-MenY antibody titers | ||||||||||||||||||||||||||||||||||||
End point description |
Titres are expressed as Geometric Mean Titers (GMTs). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA-MenC and hSBA-MenY antibody titers | ||||||||||||||||||||||||
End point description |
Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and one month after fourth dose vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with anti-PSC and anti-PSY antibody concentrations equal to or above the cut-off values | |||||||||||||||||||||
End point description |
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PSC and anti-PSY antibody concentrations equal to or above the cut-off values | |||||||||||||||||||||||||||||||||
End point description |
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and one month after fourth dose vaccination
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-PSC and anti-PSY antibodies concentrations | ||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-PSC and anti-PSY antibody concentrations | ||||||||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and one month after fourth dose vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with anti-PRP antibody concentrations equal to or above the cut-off value | ||||||||||||||||||||||||
End point description |
Anti-PRP antibody cut-off values assessed were >=0.15 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-PRP antibody concentrations | ||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after the primary vaccination course and prior to the fourth dose vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenC and hSBA-MenY antibody titers equal to or above the cut-off values | ||||||||||||||||||||||||||||||||||||||||||
End point description |
hSBA-MenC and hSBA-MenY antibody cut-off values assessed were >=1:4 and >=1:8. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
One month after the primary vaccination course
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PSC and anti-PSY antibody concentrations equal to or above the cut-off values | |||||||||||||||||||||||||||||||||
End point description |
Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-PSC and anti-PSY antibody concentrations | ||||||||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with anti-PRP antibody concentrations equal to or above 0.15 microgram per milliliter (µg/mL) | |||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and 42 days after fourth vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-PRP antibody concentrations | ||||||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Prior to the fourth vaccination and 42 days after fourth vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenC and hSBA-MenY antibody concentrations equal to or above 1:4 | |||||||||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and 42 days after fourth vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with anti-measles antibody concentrations equal to or above 200 milli-international units per millilitre (mIU/mL) | ||||||||||||
End point description |
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
42 days after the fourth vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-measles antibody concentrations | |||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
42 days after fourth vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with anti-mumps titer equal to or above the cut-off values | |||||||||||||||
End point description |
Anti-mumps antibody cut-off values assessed were >=28 estimated dose 50 (ED50) and >=51 ED50. The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
42 days after fourth vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-mumps antibody titers | |||||||||||||||
End point description |
Titers are expressed as Geometric Mean Titers (GMTs). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
42 days after fourth vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with anti-rubella antibody concentrations equal to or above 4 international units per millilitre (IU/mL) | ||||||||||||
End point description |
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
42 days after fourth vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-rubella antibody concentrations | |||||||||||||||
End point description |
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
42 days after fourth vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with anti-varicella titer equal to or above 1:40 | ||||||||||||
End point description |
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
42 days after fourth vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-varicella antibody titers | |||||||||||||||
End point description |
Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
42 days after fourth vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody titers equal to or above 1:40 | |||||||||||||||||||||||||||
End point description |
Anti-H1N1, anti-H3N2 and anti-influenza-B (anti-B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination and one month after the fourth dose vaccination
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting fever above 39.5 degrees Celsius/103.1 degrees Fahrenheit | ||||||||||||
End point description |
Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
In the 4-day (Day 0-3) follow-up period after primary vaccination course
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting fever above 39.5 degrees Celsius/103.1 degrees Fahrenheit | ||||||||||||
End point description |
Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
In the 4-day (Day0-3) follow-up period after the fourth dose
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects reporting solicited local and general symptoms | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Within the 4 days (Day 0-3) following each vaccine dose
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects reporting solicited local and general symptoms | |||||||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Within the 4 days (Day 0-3) post-vaccination period following the fourth dose
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting unsolicited adverse events (AEs) | ||||||||||||
End point description |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within 31 days (Day 0-30) following the primary vaccination course
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting unsolicited adverse events (AEs) | ||||||||||||
End point description |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within 31 days (Day 0-30) following the fourth dose
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting increased circumferential swelling at the injection limb(s) | ||||||||||||
End point description |
Increased circumferential swelling defined as either swelling with a diameter of >50 mm or a >50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within 4 days (Day 0 to Day 3) after fourth dose vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects reporting general symptoms specific to measles, mumps, rubella and varicella vaccination | |||||||||||||||||||||
End point description |
Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Within 43 days (Day 0 through Day 42) after vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting Serious Adverse Events (SAEs) | ||||||||||||
End point description |
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting Serious Adverse Events (SAEs) | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From the fourth dose through the end of the 6-month safety follow-up
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting new onset of chronic illness(es) (NOCIs) | ||||||||||||
End point description |
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting new onset of chronic illness(es) (NOCIs) | ||||||||||||
End point description |
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From the fourth dose through the end of the 6-month safety follow-up
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting rash | ||||||||||||
End point description |
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting rash | ||||||||||||
End point description |
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From the fourth dose through the end of the 6-month safety follow-up
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting adverse events resulting in emergency room (ER) visits | ||||||||||||
End point description |
Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting adverse events resulting in physicians (MD) office visits. | ||||||||||||
End point description |
Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting adverse events resulting in emergency room (ER) visits | ||||||||||||
End point description |
Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From the fourth dose through the end of the 6-month safety follow-up
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting adverse events resulting in physicians (MD) office visits | ||||||||||||
End point description |
Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From the fourth dose through the end of the 6-month safety follow-up
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with anti-PRP antibody concentration equal to or above 1.0 microgram per milliliter (µg/mL) | ||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Prior to the fourth dose vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with hSBA-MenC and hSBA-MenY antibody titer equal to or above 1:8 | |||||||||||||||
End point description |
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Prior to the fourth dose vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
SAEs: From Day 0 after Dose 1 through the day preceding the fourth dose; From the fourth dose phase through the end of the safety follow-up; AEs: within the 31-day (Day 0-30) post vaccination period; Solicited AEs: During the 4-day post vaccination period
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Results are presented for the primary phase and the fourth dose phase.
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.1
|
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Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Menhibrix Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ActHIB Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [51] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [52] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [53] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [54] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [55] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [56] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [57] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [58] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [59] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [60] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [61] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [62] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [63] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed [64] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed [65] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [66] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [67] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [68] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [69] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. [70] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed only on subjects who received a fourth dose of Hib-MenCY-TT vaccine. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 Mar 2006 |
The aims of this trial are to demonstrate the consistency of 3 manufacturing lots of GSK Biologicals' Hib-MenCY-TT candidate vaccine in terms of immunogenicity, the immunogenicity of Hib-MenCY-TT vaccine against N. meningitidis serogroups C and Y and the non-inferiority of GSK Biologicals' Hib-MenCY-TT vaccine with respect to immunogenicity and safety compared to the control vaccine (ActHIB) when each are co-administered with Pediarix to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety of a booster dose of Hib-MenCY-TT vaccine at 12 to 15 months of age as compared to PedvaxHIB. Finally, immunogenicity of a booster dose of Hib-MenCY-TT vaccine at 12 to 15 months co-administered with M-M-R II and Varivax will be evaluated. The booster immunogenicity will be performed on data from 2 studies: the current study and a second study with the same design, the non-US study, Hib-MenCY-TT-007/008, which is being conducted under US Investigational New Drug (IND) application. |
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05 Oct 2006 |
The aims of this trial are to demonstrate the consistency of 3 manufacturing lots of GSK Biologicals' Hib-MenCY-TT candidate vaccine in terms of immunogenicity, the immunogenicity of Hib-MenCY-TT vaccine against N. meningitidis serogroups C and Y and the non-inferiority of GSK Biologicals' Hib-MenCY-TT vaccine with respect to immunogenicity and safety compared to the control vaccine (ActHIB) when each are co-administered with Pediarix to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety of a fourth dose of Hib-MenCY-TT vaccine at 12 to 15 months of age as compared to PedvaxHIB. Finally, immunogenicity of a fourth dose of Hib-MenCY-TT vaccine at 12 to 15 months coadministered with M-M-R II and Varivax will be evaluated. The M-M-R II and Varivax co-administration analysis will be performed on data from 2 studies: the current study and a second study with the same design, the non-US study, Hib-MenCY-TT-007/008, which is being conducted under US Investigational New Drug (IND) application. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |