Last updated: 11/03/2018 13:47:58
Reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Rotarix™ (human rotavirus vaccine) in Indian infants
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
Enrollment:
332
Primary completion date:
2010-20-02
Observational study model:
Cohort
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:
- 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.
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.
Exclusion criteria:
- 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.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Trial location(s)
Showing 1 - 6 of 12 Results
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
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website