Last updated: 11/07/2018 14:22:29
A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of GSK Biologicals’ live attenuated human rotavirus vaccine at 2 different virus concentrations in healthy seropositive children between 1 and 3 years of age, when given as a single oral administration
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of GSK Biologicals’ live attenuated human rotavirus vaccine at 2 different virus concentrations in healthy seropositive children between 1 and 3 years of age, when given as a single oral administration
Trial description: A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of GSK Biologicals’ live attenuated human rotavirus vaccine at 2 different virus concentrations in healthy seropositive children between 1 and 3 years of age, when given as a single oral administration
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
De Vos B et al. (2006) A short report on clinical evaluation of RIX4414: highlights of world-wide development. Vaccine. 24 (18):3777-3778.
Vesikari T et al. (2004) Safety and immunogenicity of Rix4414 live attenuated human rotavirus vaccine in adults, toddlers and previously uninfected infants. Vaccine. 22(21-22): 2836-2842.
Medical condition
Infections, Rotavirus
Product
Rotavirus Vaccine
Collaborators
Not applicable
Study date(s)
March 2000 to April 2001
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2001-25-04
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
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website