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A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

Primary Purpose

Infections, Rotavirus

Status
Completed
Phase
Phase 3
Locations
International
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 - 13 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria: Healthy infants 6-13 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.) Child is unlikely to remain in the study area for the duration of the 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

Sites / Locations

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

Outcomes

Primary Outcome Measures

1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. 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, 11 score after Dose 2 and Dose 1 until 1-year old.
Severe RV GE in subset during the 2nd year and both years.
SAEs.
Definite IS until 1-year old and 2-years old.
Serum anti-RV IgA at Visits 1 and 3 (subset/country except Finland).

Full Information

First Posted
August 31, 2005
Last Updated
December 26, 2019
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00140673
Brief Title
A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
Official Title
A Placebo-controlled, Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 5, 2003 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 20, 2005 (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: 1) In a subset (N = 20 000), 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. 2) In all subjects (N = 60 000), 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 6-13 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. A minimum 2-week interval was to be observed between HRV vaccine and OPV doses. Of the total enrolled cohort of 60 000 subjects, 20 000 subjects were followed for efficacy and safety until one year of age while 40 000 subjects were followed for safety only until 30-90 days after the second HRV/placebo dose. A subset (N = approximately 13 000) of the 20 000 subjects are followed for efficacy and safety until 24 months of age. From the 20 000 subjects followed for efficacy and safety, a subset of 100 subjects per country (center specific, except Finland) provided two blood sample to evaluate immunogenicity.

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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63227 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Rotavirus
Primary Outcome Measure Information:
Title
1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. 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, 11 score after Dose 2 and Dose 1 until 1-year old.
Title
Severe RV GE in subset during the 2nd year and both years.
Title
SAEs.
Title
Definite IS until 1-year old and 2-years old.
Title
Serum anti-RV IgA at Visits 1 and 3 (subset/country except Finland).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
13 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Healthy infants 6-13 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.) Child is unlikely to remain in the study area for the duration of the 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
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
Villanueva
State/Province
Mendoza
ZIP/Postal Code
5521
Country
Argentina
Facility Name
GSK Investigational Site
City
Belem
State/Province
Pará
ZIP/Postal Code
66 090 000
Country
Brazil
Facility Name
GSK Investigational Site
City
Concepción
State/Province
Región Del Biobio
Country
Chile
Facility Name
GSK Investigational Site
City
Valparaiso
State/Province
Valparaíso
Country
Chile
Facility Name
GSK Investigational Site
City
Cali Colombia
Country
Colombia
Facility Name
GSK Investigational Site
City
Santo Domingo
Country
Dominican Republic
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33014
Country
Finland
Facility Name
GSK Investigational Site
City
Tegucigalpa
Country
Honduras
Facility Name
GSK Investigational Site
City
Cuernavaca
Country
Mexico
Facility Name
GSK Investigational Site
City
Durango
ZIP/Postal Code
3400
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico DF
ZIP/Postal Code
06720
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico
ZIP/Postal Code
04530
Country
Mexico
Facility Name
GSK Investigational Site
City
Tlanepantla
ZIP/Postal Code
54150
Country
Mexico
Facility Name
GSK Investigational Site
City
Leon
Country
Nicaragua
Facility Name
GSK Investigational Site
City
Panama
Country
Panama
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima
Country
Peru
Facility Name
GSK Investigational Site
City
Valencia
State/Province
Carabobo
Country
Venezuela

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=510
Citations:
Citation
Costa Clemens SA et al. Operational organization of a large scale phase III clinical trial of rotavirus vaccine in multiple sites and countries in Latin America. Poster presented at ICP, Cancun, Mexico, 15-20 August 2004.
Results Reference
background
Citation
De Vos B et al. Rotarix™: an effective way to prevent rotavirus diarrhoea and vomiting. Proc. 9th Congress of the Asian Pan Pacific Society of Paediatric Gastroenterology, Hepatology and Nutrition & 27th Annual Congress of the Malaysian Paediatric Association, Kuala Lumpur, 16-19 June 2005.
Results Reference
background
Citation
Macias M et al. The rotavirus vaccine RIX4414 (Rotarix) is not associated with intussusception in one year old infants. Proc. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Washington DC, USA, 16-19 December 2005.
Results Reference
background
Citation
O'Ryan et al. A novel rotavirus vaccine RIX4414 is not associated with intussusception. Proc. 44th ICAAC, Washington DC, USA, October 30-November 2, 2004.
Results Reference
background
PubMed Identifier
16394298
Citation
Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.
Results Reference
background
Citation
Vesikari et al. High efficacy of two doses of Rotarix™ (RIX4414) against rotavirus disease in Europe, Latin-America and Asia. Presented at ACPID, Cebu, Philippines, 7-10 March 2006.
Results Reference
background
Citation
Vesikari T et al. Overcoming the safety hurdle: the rotavirus vaccine RIX4414 is not associated with intussusception. 23rd Annual Meeting of European Society for Paediatric Infectious Diseases, Valencia, Spain, 18-20 May 2005.
Results Reference
background
Citation
Vesikari T et al. RIX4414: A new attenuated human rotavirus vaccine. 23rd Annual Meeting of European Society for Paediatric Infectious Diseases, Valencia, Spain, 18-20 May 2005.
Results Reference
background
PubMed Identifier
24047799
Citation
Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
Results Reference
background
PubMed Identifier
19289978
Citation
De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177.
Results Reference
background
PubMed Identifier
27657348
Citation
Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.
Results Reference
background
PubMed Identifier
23147138
Citation
Justino MC, Araujo EC, van Doorn LJ, Oliveira CS, Gabbay YB, Mascarenhas JD, Miranda YS, Guerra Sde F, Silva VB, Linhares AC. Oral live attenuated human rotavirus vaccine (Rotarix) offers sustained high protection against severe G9P[8] rotavirus gastroenteritis during the first two years of life in Brazilian children. Mem Inst Oswaldo Cruz. 2012 Nov;107(7):846-53. doi: 10.1590/s0074-02762012000700002.
Results Reference
background
PubMed Identifier
18395579
Citation
Linhares AC, Velazquez FR, Perez-Schael I, Saez-Llorens X, Abate H, Espinoza F, Lopez P, Macias-Parra M, Ortega-Barria E, Rivera-Medina DM, Rivera L, Pavia-Ruz N, Nunez E, Damaso S, Ruiz-Palacios GM, De Vos B, O'Ryan M, Gillard P, Bouckenooghe A; Human Rotavirus Vaccine Study Group. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008 Apr 5;371(9619):1181-9. doi: 10.1016/S0140-6736(08)60524-3.
Results Reference
background
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
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/023
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/023
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/023
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
444563/023
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/023
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
444563/023
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
444563/023
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 the HRV Vaccine in Healthy Infants.

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