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

Diphtheria Immunisation Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diphtheria
• Diphtheria Immunisation
• Pertussis Immunisation
• Poliomyelitis
• Tetanus
• Tetanus Immunisation
• Whooping Cough

• NCT number: NCT04300192
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: January 27, 2021
• Completion date: January 11, 2023