N/A
N=522
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Infections, Rotavirus
Bottom Line
View on ClinicalTrials.gov: NCT00779779 ↗Enrolled (actual)
522
Serious AEs
0.2%
Results posted
Jul 2010
Primary outcome: Primary: Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea — 78 subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rotarix™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea |
78 | — |
| SECONDARY Number of Subjects Reporting Each Type of Solicited General Symptoms |
71; 24; 124; 83; 152; 45 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
25 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
1 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT00779779). 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.