drugset / Trial / NCT00553228
Pertussis Maternal Immunization Study
Phase 2/3
Completed
320 enrolled
Scott Halperin
IWK Health Centre · collabSanofi Pasteur, a Sanofi Company · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease
Timeline
- Start
- 2007-11
- Primary completion
- 2015-12-09
- Completion
- 2015-12-09
Publications
- Brousseau N, Angers-Goulet ME, Bastien R, Ye L, Sadarangani M, Halperin SA. Vaccination during pregnancy and modulation of IgG response to pertussis vaccines in infants: The impact of different vaccine formulations. Vaccine. 2024 Apr 2;42(9):2138-2143. doi: 10.1016/j.vaccine.2024.03.015. Epub 2024 Mar 8.
- Halperin SA, Langley JM, Ye L, MacKinnon-Cameron D, Elsherif M, Allen VM, Smith B, Halperin BA, McNeil SA, Vanderkooi OG, Dwinnell S, Wilson RD, Tapiero B, Boucher M, Le Saux N, Gruslin A, Vaudry W, Chandra S, Dobson S, Money D. A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response. Clin Infect Dis. 2018 Sep 14;67(7):1063-1071. doi: 10.1093/cid/ciy244.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Td | Vaccine | 0.5 ml | Intramuscular |
| Subject | Tdap | Unknown | 0.5 ml | Intramuscular |
Indications
No indication recorded.