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DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a 2nd Year of Life Booster in HIV-Exposed Infected and Uninfected

2016-06-29 20:53:21 | BioPortfolio

Summary

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).

Primary Objectives:

- 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.

Secondary Objectives

- 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.

Description

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Diphtheria

Intervention

Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine, Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine

Location

Bertsham
South Africa

Status

Recruiting

Source

Sanofi

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-29T20:53:21-0400

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Medical and Biotech [MESH] Definitions

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

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A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)

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