Last updated: 11/07/2018 14:22:48
A phase II, double-blind, randomized, placebo-controlled, dose-escalating, stepwise study to assess safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ live attenuated human rotavirus (HRV) vaccine in healthy infants previously uninfected with human rotavirus.
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 II, double-blind, randomized, placebo-controlled, dose-escalating, stepwise study to assess safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ live attenuated human rotavirus (HRV) vaccine in healthy infants previously uninfected with human rotavirus.
Trial description: A phase II, double-blind, randomized, placebo-controlled, dose-escalating, stepwise study to assess safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ live attenuated human rotavirus (HRV) vaccine in healthy infants previously uninfected with human rotavirus.
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.
Szakal ED et al. Rotavirus anaemia in rotavirus vaccine recipients and in infants with wild type rotavirus infection. Abstract presented at the 2nd European Rotavirus Biology Meeting. Stockholm, Sweden, 3-6 June 2007.
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.
Vesikari T et al. Comparison between RIX4414 and the 89-12 human rotavirus (HRV) strains in previously uninfected children. Abstract presented at the 20th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Vilnius, Lithuania, 29–31 May 2002.
Vesikari T et al. Evaluation of an Oral Human Rotavirus (HRV) Vaccine in Europe. Abstract presented at the 3rd World Congress of Pediatric Infectious Diseases (WSPID). Santiago, Chile, 19-23 November 2002.
Vesikari T et al. Evaluation of an oral human rotavirus (HRV) vaccine in adults, HRV seropositive toddlers and previously HRV uninfected infants. Abstract presented at the Annual World Vaccine Congress (WVC). Montreal, Quebec, Canada, 15-17 April 2002.
Vesikari T et al. Evaluation of an oral human rotavirus vaccine (HRV) in adults, HRV seropositive toddlers and previously HRV uninfected infants. Abstract presented at the Proc World Vaccine Congress (WVC). Sydney, Australia, 27-28 November 2002.
Vesikari T et al. Reactogenicity and Immunogenicity of a Human Rotavirus Vaccine (HRV), given as Primary Vaccination to Healthy Infants Aged 6 to 12 Weeks. Abstract presented at the Proc Vaccines for Enteric Diseases (VED). Tampere, Finland, 12-14 September 2001.
Medical condition
Infections, Rotavirus
Product
Rotavirus Vaccine
Collaborators
Not applicable
Study date(s)
May 2000 to December 2000
Type
Not applicable
Phase
2
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
2000-18-12
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
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Access to clinical trial data by researchers
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