Clinical Trials Logo
  1. Home
  2. Rotavirus Gastroenteritis
  3. NCT02062385

Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

Rotavirus Gastroenteritis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants

Clinical Trial Summary

This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02062385
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date May 30, 2014
Completion date June 11, 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT01575197 - Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana Phase 4
Completed NCT01202201 - A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan N/A
Completed NCT00953056 - A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED) Phase 1
Completed NCT00737503 - Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab Phase 4
Completed NCT04185545 - Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates Phase 3
Completed NCT03474055 - Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India Phase 2/Phase 3
Completed NCT01236066 - Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia N/A
Completed NCT00489567 - Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden N/A
Completed NCT02584816 - Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization Phase 3
Completed NCT02133690 - A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants Phase 3
Completed NCT01177657 - Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil N/A
Completed NCT00740935 - Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. Phase 4
Completed NCT01265355 - Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement Phase 2/Phase 3
Completed NCT00169455 - Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants Phase 3
Completed NCT04819412 - To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus Phase 3
Completed NCT02728869 - Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants Phase 1/Phase 2
Recruiting NCT05958771 - The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E Phase 3
Recruiting NCT01061658 - Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine Phase 1/Phase 2
Completed NCT01026779 - Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island
Completed NCT01508533 - Epidemiology of Rotavirus Infection in North India Community N/A