EUCTR2012-004039-21-Outside-EU/EEA
Active, not recruiting
Not Applicable
An open, multicentric, post-marketing surveillance study to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ live attenuated oral Human Rotavirus (HRV) vaccine, Rotarix when administered according to the Prescribing Information, in Filipino subjects aged at least 6 weeks at the time of first vaccination. - Rota-043
DrugsRotarix
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1439
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
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 first vaccination.
- •Written informed consent was to be obtained from the parent(s)/ or guardian(s) of each the subject
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1439
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
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 gastrointestinal (GI) tract.
- •Any contraindications as stated in the Prescribing Information (PI).
Outcomes
Primary Outcomes
Not specified
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