A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00432380
First received: February 6, 2007
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
| Condition | Intervention | Phase |
|---|---|---|
|
Rotavirus Gastroenteritis |
Biological: HRV liquid vaccine (GSK 357941A) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Anti-rotavirus IgA antibody seroconversion at Month 3.
Secondary Outcome Measures:
- Solicited symptoms (Day 0-7); unsolicited Adverse Events(Day 0-30); Serious Adverse Events(full study)
- Presence of RV in gastroenteritis (GE) stools.
| Estimated Enrollment: | 375 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: HRV liquid vaccine (GSK 357941A)
Other Name: HRV liquid vaccine (GSK 357941A)
Eligibility| Ages Eligible for Study: | 5 Weeks to 10 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
- Birth weight of the subject should be > 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 study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine 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. BCG is administered at birth according to the local EPI.
- Concurrently participating in another clinical study, at any time during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Contacts and Locations
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00432380 History of Changes |
| Other Study ID Numbers: | 109216 |
| Study First Received: | February 6, 2007 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
Keywords provided by GlaxoSmithKline:
|
Placebo Double blind Gastroenteritis Randomized Oral live attenuated human rotavirus liquid vaccine |
Additional relevant MeSH terms:
|
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013