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

Completed

• Conditions: Infections, Rotavirus
• Interventions: Biological: Rotarix™

• Registration Number: NCT00779779
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Study Start: 2008-11-22
• Primary Completion: 2009-05-25
• Study Completion: 2009-08-26
• Results First Submitted: 2010-06-29
• Results First Submitted QC: 2010-06-29
• Results First Posted: 2010-07-30
• Status Verified: 2011-02
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• 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.

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rotarix Group	Rotarix™	Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea	During the 8-day solicited follow-up period	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	During the 31-day follow-up period	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.
Number of Subjects Reporting Each Type of Solicited General Symptoms	During the 8-day follow-up period	Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
Number of Subjects Reporting Serious Adverse Events (SAEs)	Throughout the study period (Day 0 to Month 3 or 4)	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

Trial Locations

Locations (1)

GSK Investigational Site; 🇱🇰 Colombo, Sri Lanka