Phase 3
N=1,613
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
Infections, Rotavirus
Bottom Line
View on ClinicalTrials.gov: NCT00420316 ↗Enrolled (actual)
1,613
Serious AEs
0.7%
Results posted
Feb 2017
Primary outcome: Primary: Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) — 4; 3 Subjects — p=0.691
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rotarix (primary vaccination study) (Biological); Placebo (primary vaccination study) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) |
4; 3 | 0.691 |
| SECONDARY Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) |
1; 1 | 0.551 |
| SECONDARY Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype |
0; 2 | — |
| SECONDARY Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype |
0; 1 | 0.33 |
| SECONDARY Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype |
4; 1 | 1 |
| SECONDARY Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype |
1; 0 | 1 |
| SECONDARY Number of Subjects With Severe Gastroenteritis (GE) |
15; 6 | 0.817 |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
4; 7 | — |
| SECONDARY Number of Subjects Reporting Intussusception (IS) |
0; 0 | — |
Summary
To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.
Eligibility Criteria
Inclusion Criteria
- A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
- Written informed consent obtained from the parent or guardian of the subject.
Data sourced from ClinicalTrials.gov (NCT00420316). 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.