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

Hepatitis B Clinical Trial

Official title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Given as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and in HIV-Exposed Uninfected Infants in Republic of South Africa

Status Completed

Clinical Trial Summary

This study aims 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 and in HIV-exposed infected infants.

The primary objectives of the study are:

• 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 dose 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.

The secondary objectives of the study are:

• 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.

Clinical Trial Description

Male and female infants born from HIV-infected mothers will be tested for HIV infection from birth to 6 weeks of age. HIV infected and HIV uninfected participants will be enrolled into two groups at Day 0. Some infants detected HIV-exposed infected outside of the hospital center facilities and the trial screening procedure may also be enrolled. All participants 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. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Diphtheria
• Hepatitis
• Hepatitis B
• HIV Infections
• Human Immunodeficiency Virus Infection
• Immunologic Deficiency Syndromes
• Pertussis
• Polio
• Tetanus
• Whooping Cough

• NCT number: NCT02817451
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: July 14, 2016
• Completion date: February 22, 2019