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A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

Primary Purpose

Infections, Rotavirus

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Rotavirus
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Rotavirus

Eligibility Criteria

6 Weeks - 17 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria: Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Child is unlikely to remain in the study area during study. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator. First or second degree of consanguinity of parents.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Secondary Outcome Measures

Severe RV GE by wild-type G1, non-G1, each non-G1 and severe GE from 2 weeks after Dose 1 and 2 until 2-year old. SAEs. Mortality. Definite IS until 2-years old. Serum anti-RV IgA at Visits 1 and 3 (100 subjects/country).

Full Information

First Posted
September 15, 2005
Last Updated
November 3, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00197210
Brief Title
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Official Title
A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.
Detailed Description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age in Hongkong and Taiwan or 11-17 weeks of age in Singapore, according to a 0, 1 to 2-month schedule. Routine vaccinations are given concomitantly with the study vaccines at 2 or 3 and 4 months of age according to each local country regulation. Whenever OPV is used, a minimum 2-week interval should be observed between HRV vaccine and OPV doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10708 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Rotavirus
Primary Outcome Measure Information:
Title
Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
Secondary Outcome Measure Information:
Title
Severe RV GE by wild-type G1, non-G1, each non-G1 and severe GE from 2 weeks after Dose 1 and 2 until 2-year old. SAEs. Mortality. Definite IS until 2-years old. Serum anti-RV IgA at Visits 1 and 3 (100 subjects/country).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
17 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Child is unlikely to remain in the study area during study. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator. First or second degree of consanguinity of parents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
Citation
Guillermo M et al. RIX4414 (Rotarix™) has demonstrated efficacy during the first 2 years of life in infants from 11 Latin American countries. Abstract presented at the 10th International Rotavirus Symposium (IRS), Bangkok, Thailand, 19-21 Sep 2012.
Results Reference
background
PubMed Identifier
23499605
Citation
Lau YL, Nelson EA, Poon KH, Chan PK, Chiu S, Sung R, Leung CW, Ng D, Ma YM, Chan D, Lee TL, Tang J, Kwan YW, Ip P, Ho M, Fung LW, Tang H, Suryakiran PV, Han HH, Bock H; Hong Kong Rotarix Study Group. Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial. Vaccine. 2013 Apr 26;31(18):2253-9. doi: 10.1016/j.vaccine.2013.03.001. Epub 2013 Mar 13.
Results Reference
background
PubMed Identifier
19679216
Citation
Phua KB, Lim FS, Lau YL, Nelson EA, Huang LM, Quak SH, Lee BW, Teoh YL, Tang H, Boudville I, Oostvogels LC, Suryakiran PV, Smolenov IV, Han HH, Bock HL. Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study. Vaccine. 2009 Oct 9;27(43):5936-41. doi: 10.1016/j.vaccine.2009.07.098. Epub 2009 Aug 11.
Results Reference
background
Citation
Phua KB et al. Efficacy of rotavirus vaccine RIX4414 during the first 3 years of life: a randomised, double-blind, placebo-controlled study in infants from Hong Kong, Singapore and Taiwan. Abstract presented at the 10th International Rotavirus Symposium (IRS), Bangkok, Thailand, 19-21 Sep 2012.
Results Reference
background
Citation
Phua KB et al. Human rotavirus vaccine RIX4414 (Rotarix™) is highly efficacious in Asian infants during the first three years of life. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.
Results Reference
background
Citation
Phua KB et al. Human rotavirus vaccine RIX4414 (Rotarix™) is highly efficacious in infants from Asia during the first two years of life. Abstract presented at the 13th International Congress on Infectious Diseases (ICID). Kuala Lumpur, Malaysia, 19-22 June 2008.
Results Reference
background
Citation
Phua KB et al. Human rotavirus vaccine RIX4414 is highly efficacious in Asian infants during the third year of life. Abstract presented at the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Brussels, Belgium, 9-13 June 2009.
Results Reference
background
PubMed Identifier
21323176
Citation
Lim FS, Phua KB, Lee BW, Quak SH, Teoh YL, Ramakrishnan G, Han HH, Van Der Meeren O, Jacquets JM, Bock HL. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 2011 Jan;42(1):138-47.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/028/029/030
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/028/029/030
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/028/029/030
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/028/029/030
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 444563/028 are summarised with studies 444563/029, 444563/030, 107070, 107072, and 107076 on the GSK Clinical Study Register.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/028/029/030
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/028/029/030
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

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