To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00345956
First received: June 28, 2006
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo
| Condition | Intervention | Phase |
|---|---|---|
|
Rotavirus Infection Gastroenteritis |
Biological: Human rotavirus liquid vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Bio Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Eligibility| Ages Eligible for Study: | 6 Weeks to 10 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of > 2000 grams.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
Contacts and Locations More Information
Publications:
Anh DD et al. (2011) Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) when co-administered with Expanded Program on Immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 29(11):2029-2036.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00345956 History of Changes |
| Other Study ID Numbers: | 105722 |
| Study First Received: | June 28, 2006 |
| Last Updated: | November 21, 2012 |
| Health Authority: | Vietnam: Ministry of Health |
Keywords provided by GlaxoSmithKline:
|
Prophylaxis against gastroenteritis caused by Rotavirus |
Additional relevant MeSH terms:
|
Gastroenteritis Rotavirus Infections Gastrointestinal Diseases Digestive System Diseases |
Reoviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013