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

Purpose

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	Intervention	Phase
Rotavirus Gastroenteritis Rotavirus Vaccines	Biological: Rotarix™	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Rotarix

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea [ Time Frame: During the 8-day solicited follow-up period ] [ Designated as safety issue: No ]
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:

Number of Subjects Reporting Each Type of Solicited General Symptoms [ Time Frame: During the 8-day follow-up period ] [ Designated as safety issue: No ]
Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period ] [ Designated as safety issue: No ]
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 Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (Day 0 to Month 3 or 4) ] [ Designated as safety issue: No ]
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

Enrollment:	522
Study Start Date:	November 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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

Eligibility

Ages Eligible for Study:	6 Weeks to 19 Weeks
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779779

Locations

Sri Lanka
GSK Investigational Site
Colombo, Sri Lanka, 03

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00779779 History of Changes
Other Study ID Numbers:	111664
Study First Received:	October 23, 2008
Results First Received:	June 29, 2010
Last Updated:	November 24, 2010
Health Authority:	Sri-Lanka: Not applicable

Keywords provided by GlaxoSmithKline:

Gastroenteritis

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013