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

NCT00779779 | Completed Results

• 1 other identifier: 111664
• Study Type: observational
• Target: 522
• Locations: 1 country
• Sites: 1

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).

Conditions

Infections, Rotavirus

Keywords

Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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.

  During the 8-day solicited follow-up period

Secondary Outcomes (3)

• Number of Subjects Reporting Each Type of Solicited General Symptoms

  During the 8-day follow-up period

• Number of Subjects Reporting Unsolicited Adverse Events (AEs)

  During the 31-day follow-up period

• Number of Subjects Reporting Serious Adverse Events (SAEs)

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

Study Arms (1)

Rotarix Group

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.

Biological: Rotarix™

Interventions

Rotarix™ BIOLOGICAL

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

Rotarix Group

Eligibility Criteria

• Age: 6 Weeks - 19 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Colombo, 03, Sri Lanka

Location

Related Publications (2)

• Ruberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.

  BACKGROUND

• Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.

  PMID: 25424932 DERIVED

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: November 22, 2008
• Primary Completion: May 25, 2009
• Study Completion: August 26, 2009
• Last Updated: August 28, 2018
• Results First Posted: July 30, 2010

Record last verified: 2011-02

Locations

SR (1)