Tetanus Clinical Trial
Official title:
Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)
Objectives:
- To present the rates of adverse reactions after a dose of DAPTACEL® vaccine
administered to children 4 to 6 years of age who have previously received four doses of
PENTACEL™ vaccine.
- To present immunogenicity before and after a single dose of DAPTACEL® vaccine
administered to children 4 to 6 years of age who have previously received four doses of
PENTACEL™ vaccine.
This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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 |