N/A
N=1,439
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Infections, Rotavirus · Rotavirus Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00353366 ↗Enrolled (actual)
1,439
Serious AEs
2.3%
Results posted
Aug 2011
Primary outcome: Primary: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea). — 147; 98; 212 Subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rotarix (Biological); Data collection (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea). |
147; 98; 212 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. |
311; 13; 15; 69; 13; 26 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AE) |
352 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) |
33 | — |
Summary
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A Filipino male or female aged at least 6 weeks at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
- Any contraindications as stated in the Prescribing Information.
Data sourced from ClinicalTrials.gov (NCT00353366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.