N/A
N=332
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
Infections, Rotavirus
Bottom Line
View on ClinicalTrials.gov: NCT00938327 ↗Enrolled (actual)
332
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) — 42 subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rotarix™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) |
42 | — |
| SECONDARY Number of Subjects Reporting Solicited General Symptoms |
43; 14; 81; 46; 24; 67 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
23 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
— | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00938327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.