Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00425737
First received: January 22, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
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Purpose
To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus
| Condition | Intervention | Phase |
|---|---|---|
|
Rotavirus Gastroenteritis |
Biological: Rotarix |
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: | A Study to Assess the Efficacy, Immunogenicity and Safety of Two Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in Healthy Infants. |
Resource links provided by NLM:
MedlinePlus related topics:
Gastroenteritis
Drug Information available for:
Rotarix
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of RV GE
Secondary Outcome Measures:
- Occurrence of severe RV GE, solicited symptoms (Day 0-14), unsolicited Adverse Events (Day 0-42), Serious Adverse Events (full study), presence of rotavirus antigen in stool samples, immunogenicity
| Estimated Enrollment: | 405 |
| Study Start Date: | August 2000 |
| Estimated Study Completion Date: | December 2002 |
Eligibility| Ages Eligible for Study: | 6 Weeks to 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
- Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
- Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
- 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.
- Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- Household contact with an immunosuppressed individual or pregnant woman.
- Abnormal stool pattern.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Previous confirmed occurrence of rotavirus gastroenteritis.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00425737 History of Changes |
| Other Study ID Numbers: | 444563/004 |
| Study First Received: | January 22, 2007 |
| Last Updated: | January 22, 2007 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by GlaxoSmithKline:
|
Oral live attenuated human rotavirus vaccine Gastroenteritis |
Additional relevant MeSH terms:
|
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013