Tetanus Clinical Trial
Official title:
Safety, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety
and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.
Stage I Primary Objectives:
1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered
with other recommended vaccines.
2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of
DAPTACEL when co-administered with other recommended vaccines.
3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB
concurrently administered in a different injection site with DAPTACEL when these
vaccines are co-administered with other recommended vaccines.
Stage II Primary Objectives:
1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with
Hib or other infant vaccines.
2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when
co-administered with ActHIB in toddlers.
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL ;
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 | |
|---|---|---|---|
| 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 |
NCT00514709 -
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
|
Phase 3 | |
| Completed |
NCT00534833 -
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
|
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 |