Hepatitis B Clinical Trial
Official title:
Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™
The purpose of this study is to generate immunogenicity and safety data of an
investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine,
Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.
Primary Objectives:
- To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T
vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with
Prevenar™ and Rotarix™, in terms of immunoresponses.
- To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to
the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.
Secondary Objectives:
- To describe in each group the immunogenicity parameters for all antigens for each
vaccine
- To assess the safety profile in terms of solicited and unsolicited adverse events and
serious adverse events in each group for each vaccine.
Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent
vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6
months of age and Rotarix™ at 2 and 4 months of age.
All participants will be monitored for safety for 6 months after the last injection of the
primary vaccination series.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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