N/A
N=3,111
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
Infections, Rotavirus
Bottom Line
View on ClinicalTrials.gov: NCT00750893 ↗Enrolled (actual)
3,111
Serious AEs
0.8%
Results posted
Feb 2011
Primary outcome: Primary: Number of Subjects Reporting Solicited General Symptoms — 204; 50; 405; 259 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rotarix or Rotarix liquid formulation (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Solicited General Symptoms |
204; 50; 405; 259; 135; 200 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period |
334 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period |
413 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period |
254 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period |
1201 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period |
6 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period |
13 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period |
4 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period |
26 | — |
Summary
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.
Eligibility Criteria
Inclusion Criteria
- Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.
- A male or female infant from the age of 6 weeks at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the infant.
Exclusion Criteria
- At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
Data sourced from ClinicalTrials.gov (NCT00750893). 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.