drugset / Trial / NCT00870350
An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster
Phase 4
Unknown
400 enrolled
Swedish Institute for Infectious Disease Control
MCM Vaccines B.V. · collabStatens Serum Institut · collab
RandomizedParallel-groupOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2009-04
- Primary completion
- 2009-10
- Completion
- 2010-06
Publications
- Lin A, Apostolovic D, Jahnmatz M, Liang F, Ols S, Tecleab T, Wu C, van Hage M, Solovay K, Rubin K, Locht C, Thorstensson R, Thalen M, Lore K. Live attenuated pertussis vaccine BPZE1 induces a broad antibody response in humans. J Clin Invest. 2020 May 1;130(5):2332-2346. doi: 10.1172/JCI135020.
- Carlsson RM, Gustafsson L, Hallander HO, Ljungman M, Olin P, Gothefors L, Nilsson L, Netterlid E. Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years. Vaccine. 2015 Jul 17;33(31):3717-25. doi: 10.1016/j.vaccine.2015.05.079. Epub 2015 Jun 7.
- Jahnmatz M, Ljungman M, Netterlid E, Jenmalm MC, Nilsson L, Thorstensson R. Pertussis-specific memory B-cell and humoral IgG responses in adolescents after a fifth consecutive dose of acellular pertussis vaccine. Clin Vaccine Immunol. 2014 Sep;21(9):1301-8. doi: 10.1128/CVI.00280-14. Epub 2014 Jul 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | REPEVAX | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Td1aP | Vaccine | 0.5 ml | Intramuscular |