drugset / Trial / NCT01446289
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
RandomizedParallel-groupSingle-blindPrevention
Summary
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-04
- Completion
- 2013-10
Publications
- Fabbrini M, Rigat F, Tuscano G, Chiarot E, Donders G, Devlieger R, Filippini S, Frigimelica E, Forte P, Wittke F, Halperin SA, Slobod K, Grandi G, Margarit I. Functional activity of maternal and cord antibodies elicited by an investigational group B Streptococcus trivalent glycoconjugate vaccine in pregnant women. J Infect. 2018 May;76(5):449-456. doi: 10.1016/j.jinf.2018.01.006. Epub 2018 Jan 31.
- Donders GG, Halperin SA, Devlieger R, Baker S, Forte P, Wittke F, Slobod KS, Dull PM. Maternal Immunization With an Investigational Trivalent Group B Streptococcal Vaccine: A Randomized Controlled Trial. Obstet Gynecol. 2016 Feb;127(2):213-21. doi: 10.1097/AOG.0000000000001190.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Group B Streptococcus Trivalent Vaccine | Vaccine | — | Intramuscular |