Back to resultsEvaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Primary Purpose
Infections, Rotavirus
Status
Completed
Phase
Locations
Sri Lanka
Study Type
Observational
Intervention
Rotarix™
Sponsored by
About this trial
This is an observational trial for Infections, Rotavirus focused on measuring Gastroenteritis
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Arm Label
Rotarix Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Subjects Reporting Each Type of Solicited General Symptoms
Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00779779
Brief Title
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
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 Type
Observational
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 22, 2008 (undefined)
Primary Completion Date
May 25, 2009 (Actual)
Study Completion Date
August 26, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus
Keywords
Gastroenteritis
7. Study Design
Enrollment
522 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotarix Group
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Rotarix™
Intervention Description
Two oral doses, with at least 4 weeks interval in-between
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea
Description
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 Outcome Measure Information:
Title
Number of Subjects Reporting Each Type of Solicited General Symptoms
Description
Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
Time Frame
During the 8-day follow-up period
Title
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description
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
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
19 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Colombo
ZIP/Postal Code
03
Country
Sri Lanka
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
25424932
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
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