Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)

Summary

The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113\_01 study. There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn. No vaccine was administered and no safety data was collected in this study.

Timeline

Start

2015-04

Primary completion

2015-06

Completion

2015-06

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

Indications