Evaluation of reactogenicity and safety of GSK Biologicals’ Rotarix (human rotavirus vaccine) in infants.

Conditions: Rotavirus Gastroenteritis
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-001546-28-Outside-EU/EEA

Lead Sponsor: Smithkline Beecham Pvt Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 522

Inclusion Criteria

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
A male or female at least 6 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.

Are the trial subjects under 18? yes
Number of subjects for this age range: 522
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 exac-erbated by any component of the vaccine.
Acute disease at the time of enrolment.
Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Any contraindication as stated in the updated and approved Prescribing Information

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 reactogenicity of Rotarix in terms of occur-rence of at least one grade 2” or grade 3” fever, vomiting or diarrhoea within a 8-day follow-up period after each vaccine dose;Secondary Objective: To assess the reactogenicity of Rotarix in terms of occurrence of solicited adverse events (AEs) within a 8-day follow-up period after each vaccine dose.<br>To assess the safety of Rotarix in terms of occurrence of unsolicited AEs within a 31-day follow-up period after each vaccine dose.<br>To assess the safety of Rotarix in terms of serious adverse events (SAEs) throughout the study period after Dose 1 of Rotarix<br>;Primary end point(s): Occurrence of at least one grade 2” or grade 3” fever, vomiting or diarrhoea;Timepoint(s) of evaluation of this end point: During the 8-day follow-up period after each vaccine dose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): For each type of solicited symptoms, occurrence of the symptom <br>Occurrence of unsolicited adverse event (AE)<br>Occurrence of Serious adverse events;Timepoint(s) of evaluation of this end point: Solicited symptoms: During the 8-day follow-up period after each vaccine dose, Unsolicited AEs: During the 31-day follow-up period after each vaccine dose, SAEs:Throughout the study period (Month 3-4)