Last updated: 11/03/2018 09:29:51
To assess immunogenicity, reactogenicity & safety of 2 formulations of GSK's HRV vaccine as 2-dose vaccination (infants)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to assess the immunogenicity, reactogenicity and safety of 2 different formulations of GSK Biologicals' live attenuated HRV vaccine, given as a two-dose primary vaccination, in healthy infants previously uninfected with HRV
Trial description: 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
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroconverted subjects against human rotavirus
Timeframe: At 1 to 2 months after the second vaccine dose (Months 3-4)
Secondary outcomes:
Concentrations of anti-rotavirus IgA antibodies
Timeframe: At 1 to 2 months after the second vaccine dose (Months 3-4)
Number of subjects with vaccine take for anti-rotavirus IgA antibodies
Timeframe: At 1 to 2 months after the second vaccine dose (Months 3-4)
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.
Number of subjects with unsolicited adverse events (AEs)
Timeframe: Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months
Number of subjects with serious adverse events (SAEs)
Timeframe: Throughout the entire study period (from Day 0 to Month 4)
Number of subjects with rotavirus in stool samples collected during gastroenteritis episodes
Timeframe: From the first vaccine dose (Dose 1) up to Month 4
Interventions:
Biological/vaccine: Lyophilized formulation of HRV vaccine
Biological/vaccine: Liquid formulation of HRV vaccine
Enrollment:
1274
Observational study model:
Not applicable
Primary completion date:
2007-12-04
Time perspective:
Not applicable
Clinical publications:
Velasquez AA et al. Immunogenicity of The Oral Live Attenuated Human Rotavirus Vaccine RIX4414 (Rotarix™) Oral Suspension (Liquid Formulation) Co-administered with Childhood Vaccinations in Panama. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
September 2006 to April 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-12-04
Actual study completion date
2007-12-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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