NCT02817451

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 5 Weeks – 8 Weeks
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Polio
• Human Immunodeficiency Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine	0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
BIOLOGICAL	Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine	0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months

Timeline

• Start date: 2016-07-14
• Primary completion: 2019-02-22
• Completion: 2019-02-22
• First posted: 2016-06-29
• Last updated: 2022-04-05

Locations

1 site across 1 country: South Africa