Tetanus Clinical Trial
Official title:
An Immunogenicity and Safety Study of Combined Adsorbed Tetanus, Low Dose Diphtheria and Acellular Pertussis Vaccine (Td5ap and Td1aP) Given as a School-leaving Booster to 14-15-year-old Children Primed With a Five Component Acellular Pertussis Vaccine at 3, 5 and 12 Months of Age, and a Booster Dose at 5½ Years of Age
Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups, will receive Td5ap or Td1aP as a single injection. We will then describe the immune response and safety profile of the combined vaccine booster.
The vaccines in the study are COVAXIS (Td5ap), Sanofi Pasteur Canada, and diTekiBooster
(Td1aP), Statens Serum Institut, Denmark.
The primary objective of the study is to describe the immune response to diphtheria toxin,
tetanus toxoid, pertussis toxin, filamentous haemagglutinin (FHA), fimbriae 2/3 and
pertactin four weeks after immunization with Td1aP and Td5ap.
The secondary objectives include:
- describing the safety of a fith dose of DTP vaccines in 14-15 year-old children by
observing systemic and local adverse reactions
- describing pre-booster antibody levels
- describing pre-booster and post-booster IgG and IgA levels in saliva
- describing in a subpopulation the pre-booster and post-booster T cell immune responses
as determined by the production of cytokines
- describing in a subpopulation the pre-booster and post-booster B cell immune responses
as determined by the number of effector and memory B-cells
The sample size is 400 subjects (200 in group 1 and 200 in group 2). It will be an
open-label, randomized, multi-centre study in which group 1 will receive Td5ap as a single
injection and group 2 will receive Td1aP as a single injection. DTP antibodies will be
measured before and 28 days (+ 14 days) after Td5ap and Td1aP vaccination. The proportion of
children with positive IgG antibody response will be measured in each study arm. Sera will
be tested blindly by established ELISA methods and saliva samples will be analyzed by
exploratory assays. In a subpopulation cellmediated immunity will be analyzed. The safety
evaluation criteria will be the percentage of subjects with adverse events describing
injection-site adverse reactions, systemic adverse events, daily temperatures and serious
adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
| Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
| Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
| Completed |
NCT02538211 -
The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
|
N/A | |
| Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
| Completed |
NCT01689324 -
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents
|
Phase 1/Phase 2 | |
| Completed |
NCT01444781 -
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
|
Phase 3 | |
| Completed |
NCT01214889 -
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
|
Phase 3 | |
| Completed |
NCT00804284 -
Database Surveillance Safety Study of PENTACEL® Vaccine
|
N/A | |
| Completed |
NCT00534833 -
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
|
Phase 3 | |
| Completed |
NCT00514709 -
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
|
Phase 3 | |
| Completed |
NCT00379977 -
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
|
Phase 3 | |
| Completed |
NCT00772369 -
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
|
Phase 4 | |
| Completed |
NCT00879827 -
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
|
Phase 3 | |
| Completed |
NCT01457495 -
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
|
Phase 2 | |
| Completed |
NCT01267058 -
Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT02853929 -
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
|
Phase 4 | |
| Completed |
NCT02858440 -
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
|
Phase 3 | |
| Recruiting |
NCT06049940 -
Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
|
Phase 3 | |
| Completed |
NCT00385255 -
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
|
Phase 3 |