Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00139347
First received: August 30, 2005
Last updated: November 21, 2012
Last verified: November 2012

August 30, 2005
November 21, 2012
December 2003
March 2007   (final data collection date for primary outcome measure)
Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
Same as current
Complete list of historical versions of study NCT00139347 on ClinicalTrials.gov Archive Site
Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines
  • Occurrence of severe RV GE caused by the wild RV strain of serotype G1, non-G1 serotypes and due to each non-G1 serotypes during the period starting from 2 weeks after Dose 2 until 1 year old.
  • Occurrence of severe RV GE caused by the circulating wild RV strains, of severe RV GE caused by the wild RV strain of serotype G1, of severe RV GE due to non-G1 serotypes and of severe RV GE due to each non-G1 serotype from Dose 1 until 1 year old.• Ser
  • • Immune response to EPI vaccinations at one to 2 months after the3rd dose of routine EPI vaccinations (at Visit 4).
  • In a subset of 400 subjects enrolled in year 2005:
  • • Immune response to OPV at one month after each dose of routine EPI vaccinations (at Visits 2, 4 and 6)."
Not Provided
Not Provided
 
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Rotavirus Gastroenteritis
Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Other Name: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6360
Not Provided
March 2007   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion criteria:

  • Allergic reaction to vaccine components;
  • clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
  • immunocompromised.
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia,   Argentina,   Brazil,   Panama,   Dominican Republic,   Honduras
 
NCT00139347
444563/024
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP