Last updated: 11/03/2018 00:25:56
A study to test 2 doses of the HRV vaccine given with or without OPV in healthy infants in Bangladesh
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh
Trial description: The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Rotavirus
Enrollment:
300
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bhattacharya SK et al. Immune response in infants sero-positive at pre-vaccination: Human rotavirus vaccine Rotarix™. Abstract presented at 5th World Congress WSPID, Bangkok, Thailand, 15-18 November 2007.
Zaman et al. Immunogenicity of an Oral Polio Vaccine is Unaffected when Co-Administered with a Human Rotavirus Vaccine in Bangladeshi Children. Absract presented at 5th World Congress WSPID, Bangkok, Thailand, 15-18 November 2007.
Zaman K et al. (2009) Successful co-administration of a human rotavirus and oral poliovirus vaccines in Bangladeshi infants in a 2-dose schedule at 12 and 16 weeks of age. Vaccine. 27 (9): 1333-1339.
Buyse H et al. (2013) The human rotavirus vaccine Rotarix™ in infants: An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 10(1). [Epub ahead of print]
Zaman K et al. (2009) Successful co-administration of a human rotavirus and oral poliovirus vaccines in Bangladeshi infants in a 2-dose schedule at 12 and 16 weeks of age. Vaccine. 27(9):1333-1339.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
June 2005 to January 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
5 - 7 weeks
Accepts healthy volunteers
Yes
- Healthy infants aged 6 weeks±1 at first study vaccination.
- Malnutrition, no history of rotavirus gastroenteritis, allergic disease or chronic gastrointestinal disease, not received protocol-prohibited treatment.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy infants aged 6 weeks±1 at first study vaccination.
Exclusion criteria:
- Malnutrition, no history of rotavirus gastroenteritis, allergic disease or chronic gastrointestinal disease, not received protocol-prohibited treatment.
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
Not applicable
Actual study completion date
2006-04-01
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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