Last updated: 11/07/2018 02:06:21
A study in infants to test two preparations (freeze-dried or liquid) of the rotavirus vaccine (HRV vaccine).
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to evaluate clinical consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate liquid formulation compared to lyophilised formulation of the HRV vaccine administered as a two-dose primary vaccination.
Trial description: The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals’ HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals’ HRV vaccine when administered concomitantly with a combination childhood vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Enrollment:
1200
Observational study model:
Not applicable
Primary completion date:
2007-18-04
Time perspective:
Not applicable
Clinical publications:
Vesikari T et al. (2011) Immunogenicity, reactogenicity and safety of the human rotavirus vaccine, RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine. 29(11):2079-2084.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
November 2006 to August 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 17 weeks
Accepts healthy volunteers
Yes
- Healthy infants birth weigh >2000 g, 11 -17 weeks old at Dose 1 with written informed consent.
- Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy infants birth weigh >2000 g, 11 -17 weeks old at Dose 1 with written informed consent.
Exclusion criteria:
- Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-18-04
Actual study completion date
2007-24-08
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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Additional information
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