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Study is to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants (HIV-exposed uninfected) and in HIV-exposed infected infants (HIV-exposed infected).
- To evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary series in HIV-exposed infected and in HIV-exposed uninfected infants.
- To describe the persistence of all antibodies before receipt of the booster vaccination in HIV-exposed infected and in HIV-exposed uninfected infants.
- To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants.
- To describe the safety profile after each and all doses of the study vaccine administered as a 3-dose infant primary series in HIV-exposed infected and in HIV-exposed uninfected infants.
- To describe the safety profile of the study vaccine administered as a booster in HIV-exposed infected and in HIV-exposed uninfected infants.
Male and female infants born from HIV infected mothers will be tested by polymerase chain reaction (PCR) for HIV infection, infected and uninfected infants will be invited at approximately 6 weeks of age to enroll in the trial. They will be enrolled in 2 groups and will receive primary vaccinations with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age and a booster dose at approximately 15 to 18 months of age will receive a booster dose of the Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine, Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
Published on BioPortfolio: 2016-06-29T20:53:21-0400
Phase III, open, mono-center study in 177 infants who received a dose of Hep B vaccine at birth or within 1 month after birth. Infants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T c...
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The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines: A)The invest...
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent. The primary ob...
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