Phase 3
Completed N=1,274
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Infections, Rotavirus
Source: ClinicalTrials.gov NCT00363545 ↗
Enrolled (actual)
1,274
Serious AEs
5.9%
Results posted
Feb 2017
Primary outcomePrimary: Number of Seroconverted Subjects Against Human Rotavirus — 363; 319 Subjects
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted Subjects Against Human Rotavirus |
363; 319 | — |
| SECONDARY Concentrations of Anti-rotavirus IgA Antibodies |
151.2; 111.7 | — |
| SECONDARY Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies |
67; 51 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
234; 252; 22; 20; 31; 22 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
276; 285 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
37; 38 | — |
| SECONDARY Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes |
4; 2; 1; 0; 5; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria
- se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Household contact with an immunosuppressed individual or pregnant women.
- Previous confirmed occurrence of RV GE.
Data sourced from ClinicalTrials.gov (NCT00363545). 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.