Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

March 31, 2017

Study Completion Date

April 30, 2017

Conditions
Rotavirus Gastroenteritis
Interventions
BIOLOGICAL

Heat Stable Rotavirus (HSRV) Vaccine

It is a lyophilized live attenuated pentavalent (G1-G4 and P1\[8\]) heat-stable rotavirus vaccine (HSRV) comprising of all the five rotavirus strains as in licensed RotaTeq® vaccine for protection against rotavirus infection

BIOLOGICAL

Placebo for Heatstable Rotavirus vaccine

It is a lyophilized formulation comprising of all the inactive ingredients as in heat stable rotavirus vaccine without any rotavirus

BIOLOGICAL

RotaTeq®

It is a pentavalent human-bovine (WC3) reassortant live-attenuated, oral vaccine developed by Merck Research Co., West Point, Pennsylvania, USA. This vaccine contains five live reassortant rotaviruses. Four reassortant rotaviruses express the VP7 protein (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (P7\[5\]) from bovine rotavirus parent strain WC3. The fifth reassortant virus expresses the attachment protein (P1A\[8\]) from the human rotavirus parent strain and the outer capsid protein G6 from the bovine rotavirus parent strain.

Trial Locations (1)

1212

Icddr,B, Dhaka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.

INDUSTRY