Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

Phase 1 Completed 420 enrolled Novartis Vaccines

RandomizedParallel-groupTriple-blindPrevention

Summary

This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.

Timeline

Start: 2012-03
Primary completion: 2012-07
Completion: 2013-07

Publications

Leroux-Roels G, Lattanzi M, Solis CD, Contorni M, Costantini M, Moraschini L, Bardelli M, Bertholet S, Borgogni E, Buricchi F, Cantisani R, Faenzi E, Finco O, Leuzzi R, Pizza M, Rosa D, Schiavetti F, Seubert A, Spensieri F, Volpini G, Zedda L, Giudice GD, Galgani I. A phase I, randomized, controlled, dose-ranging study of investigational acellular pertussis (aP) and reduced tetanus-diphtheria-acellular pertussis (TdaP) booster vaccines in adults. Hum Vaccin Immunother. 2018 Jan 2;14(1):45-58. doi: 10.1080/21645515.2017.1385686. Epub 2017 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acellular pertussis vaccine	Vaccine	—	Intramuscular
Comparator	Licensed TdaP booster vaccine	Vaccine	—	Intramuscular
Subject	Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed)	Vaccine	—	Intramuscular
Background	Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)	Vaccine	—	—

Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

Summary

Timeline

Publications

Drugs

Indications