Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

GlaxoSmithKline522 enrolled

Overview

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).

Study Type

OBSERVATIONAL

Enrollment

522

Conditions

Infections, Rotavirus

Interventions

Rotarix™BIOLOGICAL

Two oral doses, with at least 4 weeks interval in-between

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 19 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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. Exclusion Criteria: * History of allergic disease or reactions likely to be exacerbated 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

Locations (1)

GSK Investigational Site

Colombo, Sri Lanka

Outcomes

Primary Outcomes

Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea

Grade 2 fever was defined as axillary temperature \> 38.0 to \<= 39.0 degrees Celsius and grade 3 fever as axillary temperature \> 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.

Time frame: During the 8-day solicited follow-up period

Secondary Outcomes

Number of Subjects Reporting Each Type of Solicited General Symptoms

Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.

Time frame: During the 8-day follow-up period

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Time frame: During the 31-day follow-up period

Number of Subjects Reporting Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject

Time frame: Throughout the study period (Day 0 to Month 3 or 4)

Data from ClinicalTrials.gov

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