Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

Phase 3

Completed

Interventions: Biological: Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
Biological: Infanrix hexa
Biological: Infanrix Penta
Biological: Neis-Vac-C

Brief Summary: The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 \& 5m) compared to NeisVac-C™ given with Infanrix™ hexa.

The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description: This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Group Hib-MenC	Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)	Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Hib-MenC + Infanrix™ penta vaccines.
Group Hib-MenC	Infanrix Penta	Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Hib-MenC + Infanrix™ penta vaccines.
Group NeisVac-C	Infanrix hexa	Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.
Group NeisVac-C	Neis-Vac-C	Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.

Primary Outcome Measures

Name	Time	Method
SBA-MenC titre	One month after the second dose of the Primary Vaccination Phase.
Anti-PRP concentration	One month after the second dose of the Primary Vaccination Phase

Secondary Outcome Measures

Name	Time	Method
Occurrence of any serious adverse events	Throughout the study.
SBA-MenC titres	One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PRP concentrations	One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PSC concentrations	One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination.
Anti-HBs concentrations	One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Occurrence of local solicited adverse events.	During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.
Occurrence of solicited general adverse events	During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.
Occurrence of unsolicited non-serious adverse events	Within 30 days after each vaccination

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