Last updated: 11/03/2018 13:47:58

Reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Rotarix™ (human rotavirus vaccine) in Indian infants

GSK study ID
112896
See study documents
Clinicaltrials.gov ID
NCT00938327
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Post marketing surveillance to monitor the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus vaccine, Rotarix™ when administered according to the Prescribing Information to Indian infants
Trial description: This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects reporting Grade 2 or 3 symptoms (fever, vomiting or diarrhoea)

Timeframe: During the 8-day (Day 0 – Day 7) follow-up period after each vaccination.

Secondary outcomes:

Number of subjects reporting solicited general symptoms

Timeframe: During the 8-day (Day 0 – Day 7) follow-up period after each vaccination

Number of subjects reporting unsolicited adverse events (AEs)

Timeframe: During the 31-day (Day 0 – Day 30) follow-up period after each vaccination

Number of subjects reporting serious adverse events (SAEs)

Timeframe: Throughout the study period (from Day 0 up to Day 30)

Interventions:
Biological/vaccine: Rotarix™
Enrollment:
332
Observational study model:
Cohort
Primary completion date:
2010-20-02
Time perspective:
Prospective
Clinical publications:
Kumar k et al. Safety and reactogenicity of RIX4414 live attenuated human rotavirus vaccine: An Indian post-marketing surveillance study. Abstract presented at the 48th National Conference of Indian Academy of Pediatrics (Pedicon). Jaipur, India, 19-23 January 2011.
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)
August 2009 to April 2010
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
6 weeks - 167 days
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.
  • A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Inclusion and exclusion criteria
Inclusion criteria:

    Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.

    • A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second 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.

    • Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    • Acute disease at the time of enrolment.
    • Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception.
    • Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
    • Gastroenteritis within 7 days preceding vaccination.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bangalore, India, 560 011
2.2 miles (3.5 km) away from your location
Status
Study Complete
Contact us
Location
GSK Investigational Site
Bangalore, India, 560 095
3.2 miles (5.1 km) away from your location
Status
Terminated/Withdrawn
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

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
2010-20-02
Actual study completion date
2010-23-04

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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