Active Immunization Clinical Trial
Official title:
Clinical Trial Comparing the Safety and Immunogenicity of Two Combined Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliovirus (DTaP-IPV) Vaccines Administered to Healthy Children at 2, 3½, and 16 Months of Age
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial
investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:
A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line
(DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney
cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5,
and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection
in the opposite thigh.
Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for
antibodies against diphtheria, tetanus, pertussis, polio and prp.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04799808 -
Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients, Solid Organ Recipients and Staff
|