Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women

Summary

The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 \[DTPA (BOOSTRIX)-048 PRI\] and 201334 \[DTPA (BOOSTRIX)-049 BST: 048\].

Timeline

Start

2015-10-14

Primary completion

2017-08-14

Completion

2017-10-24

Outcome

Met primary endpoint

registry analysis (superiority test); dTpa Group - Mother vs Control Group - Mother; GMC ratio 8.47 (95% CI 7.02 to 10.2); 2-sample t-test NCT02377349 ↗

registry analysis (superiority test); dTpa Group - Mother vs Control Group - Mother; GMC ratio 16.11 (95% CI 13.48 to 19.24); 2-sample t-test NCT02377349 ↗

registry analysis (superiority test); dTpa Group - Mother vs Control Group - Mother; GMC ratio 20.65 (95% CI 15.86 to 26.88); 2-sample t-test NCT02377349 ↗

Publications

• Background Perrett KP, Halperin SA, Nolan T, Martinez Pancorbo C, Tapiero B, Martinon-Torres F, Stranak Z, Virta M, Vanderkooi OG, Kosina P, Encinas Pardilla MB, Cristobal Garcia I, Zuccotti GV, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Marcos Fernandez M, Rodriguez Zambrano MA, Martin Garcia A, Asenjo de la Fuente JE, Camacho Marin MD, de la Calle Fernandez-Miranda M, Romero Espinar Y, Marchisio PG, Manzoni P, Mesaros N. Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial. Vaccine. 2020 Feb 18;38(8):2095-2104. doi: 10.1016/j.vaccine.2019.10.105. Epub 2019 Nov 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boostrix	Vaccine	—	Intramuscular

Indications

No indication recorded.