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

• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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).

Condition or disease	Intervention/treatment
Infections, Rotavirus	Biological: Rotarix™

Study Design

• Study Type: Observational
• Actual Enrollment: 522 participants
• Official Title: Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.
• Study Start Date: November 22, 2008
• Actual Primary Completion Date: May 25, 2009
• Actual Study Completion Date: August 26, 2009

Groups and Cohorts

Group/Cohort	Intervention/treatment
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™; Two oral doses, with at least 4 weeks interval in-between

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea [ Time Frame: 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 :

1. Number of Subjects Reporting Each Type of Solicited General Symptoms [ Time Frame: During the 8-day follow-up period ]
   Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
2. Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: 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.
3. Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 6 Weeks to 19 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Sri Lanka

GSK Investigational Site

Colombo, Sri Lanka, 03

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00779779 History of Changes
• Other Study ID Numbers: 111664
• First Posted: October 24, 2008
• Results First Posted: July 30, 2010
• Last Update Posted: August 28, 2018
• Last Verified: February 2011

Keywords provided by GlaxoSmithKline:

Gastroenteritis

Additional relevant MeSH terms:

Rotavirus Infections; Reoviridae Infections; RNA Virus Infections; Virus Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs