Pertussis Clinical Trial
Official title:
Immunological Effects of an Acellular Pertussis Booster Vaccination in Children, Young Adults and Elderly With Different Immunisation Background. An International Study in Finland, the Netherlands and the United Kingdom
This study aims to investigate the effects of aP booster vaccination in children, young adults and elderly on the (long-term) immune response to B. pertussis in three European countries with a different epidemiological background and primary vaccination schedule for pertussis.
The study will be performed in three European countries (UK, Finland and the Netherlands) with a different epidemiological background for pertussis incidence and different age groups will have had different primary schedules with whole cell pertussis (wP) or aP vaccines in their first year of life. Long-term memory responses will be analysed following aP booster vaccination including a detailed assessment of antigen-specific B and T cell responses, serology assays for pertussis antigens and the effect of booster vaccination on dynamic changes in immune cell subsets and gene transcription. There will be four cohorts of healthy volunteers: Cohort A - children aged between 7-10 years Cohort B - children aged between 11-15 years Cohort C - adults aged between 20 to 34 years Cohort D - adults aged between 60-70 years Participants will receive one injection of reduced diphtheria toxoid, tetanus toxoid and reduced acellular pertussis vaccine (dTap)-IPV, (Boostrix® IPV, GlaxoSmithKline (GSK)) combination vaccine intramuscularly in the upper arm. Children (cohorts A and B) will be asked to donate blood four times at different time points, and young and older adults (cohorts C and D) will be asked to donate blood at set time points five times in total over the 12 months duration of the study. The time points will be: - Timepoint 0 - day of vaccination - Timepoint 1 - 1 day after T0 +/- 4 hours - Timepoint 2 - 7 days after T0 +/- 1 day - Timepoint 3 - 14 days after T0 +/- 4 days - Timepoint 4 - 28 days after T0 +/- 4 days - Timepoint 5 - 1 year after T0 +/- 4 weeks ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
| Completed |
NCT02453048 -
Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine
|
Phase 1 | |
| Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
| Completed |
NCT02526394 -
Pertussis and Meningitis C Concomitant Vaccination in Adolescents
|
Phase 4 | |
| Completed |
NCT01689324 -
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents
|
Phase 1/Phase 2 | |
| 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 |
NCT00524732 -
Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
|
N/A | |
| Completed |
NCT00772369 -
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
|
Phase 4 | |
| 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 |
NCT00004800 -
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
|
Phase 3 | |
| 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 |
NCT04023929 -
Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
|
||
| Completed |
NCT02946190 -
The PertADO Geneva Trial
|
Phase 2 | |
| Completed |
NCT03541499 -
Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults
|
Phase 2 | |
| Completed |
NCT02587520 -
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
|
Phase 1/Phase 2 | |
| Completed |
NCT04589312 -
Maternal Pertussis Wholecell Responses
|
Phase 2 |