N/A
Completed N=332
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
Infections, Rotavirus
Source: ClinicalTrials.gov NCT00938327 ↗
Enrolled (actual)
332
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea) — 42 subjects
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.
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) |
— | — |
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. Informational only — not medical advice.