Trials / Completed
CompletedNCT04300192
Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus, Diphtheria, Pertussis and Poliomyelitis) in Children Who Received Different Pertussis Primary Vaccine Regimens in Republic of South Africa
Immune Response to Pertussis After Vaccination With a Tdap-IPV Booster Vaccine in Children in the Republic of South Africa: Effect of Homologous and Heterologous Pertussis Vaccination Priming Background
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 273 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 8 Years – 14 Years
- Healthy volunteers
- Accepted
Summary
Primary Objectives : * To describe the long-term humoral immune responses to pertussis, diphtheria, and tetanus after homologous and heterologous pertussis vaccine priming regimens * To determine the effects of the priming regimen on humoral responses to booster vaccination with Tdap-IPV vaccine * To describe the long-term cell-mediated immune responses to pertussis after homologous and heterologous pertussis vaccine priming regimens * To determine the effects of the priming regimen on cell-mediated immune response to booster vaccination with Tdap-IPV vaccine Secondary Objective: To describe the safety profile of Tdap-IPV vaccine in each group
Detailed description
Study duration per participant will be approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow-up/end of study visit, at Day 8 and Day 30 after vaccine administration, respectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
Timeline
- Start date
- 2021-01-27
- Primary completion
- 2023-01-11
- Completion
- 2023-01-11
- First posted
- 2020-03-09
- Last updated
- 2025-09-12
Locations
3 sites across 1 country: South Africa
Source: ClinicalTrials.gov record NCT04300192. Inclusion in this directory is not an endorsement.