drugset / Trial / NCT04300192

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

NCT04300192

Phase 4 Completed 273 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

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

Timeline

Start
2021-01-27
Primary completion
2023-01-11
Completion
2023-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject TDaP-IPV vaccine Vaccine Intramuscular