Last updated: 11/03/2018 12:00:47
Evaluation of reactogenicity and safety of GSK Biologicals’ Rotarix™ (human rotavirus vaccine) in infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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.
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with at least one >= Grade "2" fever, vomiting or diarrhoea
Timeframe: During the 8-day solicited follow-up period
Secondary outcomes:
Number of subjects reporting each type of solicited general symptoms
Timeframe: During the 8-day follow-up period
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: During the 31-day follow-up period
Number of subjects reporting serious adverse events (SAEs)
Timeframe: Throughout the study period (Day 0 to Month 3 or 4)
Interventions:
Biological/vaccine: Rotarix™
Enrollment:
522
Observational study model:
Not applicable
Primary completion date:
2009-25-05
Time perspective:
Not applicable
Clinical 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.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
November 2008 to August 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 - 19 weeks
Accepts healthy volunteers
Yes
- 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.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
Exclusion criteria:
- 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
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2009-25-05
Actual study completion date
2009-26-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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