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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.

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004039-21-Outside-EU/EEA
Enrollment
1439
Registered
2015-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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))

Interventions

Trade Name: Rotarix Pharmaceutical Form: Powder and solvent for oral suspension INN or Proposed INN: - Other descriptive name: HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED) Concentration unit: log1

Sponsors

GlaxoSmithKline
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Occurrence of solicited symptoms. Occurrence of unsolicited symptoms, according to Medical Dictionary for Regulatory Activities (MedDRA) classification. 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) Unsolicited symptoms: During the 31-day follow up period after each vaccine dose (Day 0 to 30) SAEs: Throughout the study period (Approximately 2 - 3 months)—

Countries

Philippines

Contacts

Public ContactClinical Disclosure Advisor

GlaxoSmithKline Biologicals

GSKClinicalSupportHD@gsk.com442089904466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026