Study to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ rotavirus vaccine, when administered in Filipino subjects aged at least 6 weeks at the time of first vaccination.

Conditions: Healthy volunteers (Rotarix is indicated for the prevention of gastro-enteritis caused by Rotavirus, G1 and non G1 serotypes (such as G2, G3, G4, G9))
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2012-004039-21-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 1439

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and reactogenicity of GSK Biologicals’ Rotavirus vaccine, Rotarix;Secondary Objective: Not applicable;Primary end point(s): Occurrence of grade 2” or grade 3” fever, vomiting or diarrhea ;Timepoint(s) of evaluation of this end point: During the 15-day follow-up period after each vaccine dose (Day 0 to 14)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Occurrence of solicited symptoms.<br>Occurrence of unsolicited symptoms, according to Medical Dictionary for Regulatory Activities (MedDRA) classification.<br>Occurrence of serious adverse events (SAEs).;Timepoint(s) of evaluation of this end point: Solicited symptoms: During the 15-day follow-up period after each vaccine dose (Day 0 to 14)<br>Unsolicited symptoms: During the 31-day follow up period after each vaccine dose (Day 0 to 30)<br>SAEs: Throughout the study period (Approximately 2 - 3 months)