Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study

Summary

This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be evaluated.

Timeline

Start

2016-09

Primary completion

2017-05

Completion

2017-05

Publications

• Velasquez-Portocarrero DE, Wang X, Cortese MM, Snider CJ, Anand A, Costantini VP, Yunus M, Aziz AB, Haque W, Parashar U, Sisay Z, Soeters HM, Hyde TB, Jiang B, Zaman K. Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomised, controlled, open-label, parallel, phase 4 trial. Lancet Infect Dis. 2022 Nov;22(11):1606-1616. doi: 10.1016/S1473-3099(22)00368-1. Epub 2022 Aug 9.
• Snider CJ, Zaman K, Estivariz CF, Yunus M, Weldon WC, Wannemuehler KA, Oberste MS, Pallansch MA, Wassilak SG, Bari TIA, Anand A. Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunisation and outbreak response: an open-label, randomised controlled trial. Lancet. 2019 Jun 29;393(10191):2624-2634. doi: 10.1016/S0140-6736(19)30503-3. Epub 2019 May 16.

Drugs

Indications