Phase III Study of Liquid Formulation of ROTAVIN

Phase 3 Completed 825 enrolled Center for Research and Production of Vaccines and Biologicals, Vietnam Children's Hospital Medical Center, Cincinnati · collab National Institute of Hygiene and Epidemiology, Vietnam · collab PATH · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination.

Timeline

Start: 2019-03-16
Primary completion: 2020-01-08
Completion: 2020-01-08

Publications

Thiem VD, Anh DD, Ha VH, Hien ND, Huong NT, Nga NT, Thang TC, McNeal MM, Meyer N, Pham HL, Huong NM, Gompana G, Cassels F, Tang Y, Flores J, Rathi N. Safety and immunogenicity of two formulations of rotavirus vaccine in Vietnamese infants. Vaccine. 2021 Jul 22;39(32):4463-4470. doi: 10.1016/j.vaccine.2021.06.056. Epub 2021 Jul 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ROTAVIN	Vaccine	2 ml	Oral
Comparator	ROTAVIN-M1	Vaccine	2 ml	Oral

Phase III Study of Liquid Formulation of ROTAVIN

Summary

Timeline

Publications

Drugs

Indications