Last updated: 11/07/2018 14:24:02
Assess efficacy, immune response & safety of 2 doses of oral live attenuated HRV vaccine at different viral concentrations in healthy infants
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study to assess efficacy, immunogenicity, reactogenicity and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus vaccine at different viral concentrations in healthy infants previously uninfected with human rotavirus and approximately 3 months of age.
Trial description: To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
2464
Primary completion date:
2003-30-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
De Vos B et al. (2004) A Rotavirus Vaccine for Prophylaxis of Infants Against Rotavirus Gastroenteritis. Pediatr Infect Dis J. 23(10):179-182.
De Vos B et al. (2009) Live Attenuated Human Rotavirus Vaccine, RIX4414, Provides Clinical Protection in Infants Against Rotavirus Strains With and Without Shared G and P Genotypes: Integrated Analysis of Randomized Controlled Trials. Pediatr Infect Dis J. 28(4):261-266.
Phua KB et al. (2005) Evaluation of RIX4414 live attenuated rotavirus vaccine in a randomised double-blind placebo controlled phase II trial in 2464 Singaporean infants. J Infect Dis. 192(1):6-16.
Phua KB et al. (2006) A Rotavirus Vaccine for Prophylaxis of Infant Rotavirus Gastroenteritis: The Asian Experience. Ann Acad Med Singapore. 35(1):38-44.
Phua KB et al. (2006) A short report on highlights of worldwide development of RIX4414: A Singaporean Experience. Vaccine. 24(18):3782-3783.
Phua KB et al. (2008) Immunogenicity, Reactogenicity and Safety of a Diphtheria-Tetanus-Acellular Pertussis-Inactivated Polio and Haemophilus Influenzae Type b Combination Vaccine in a placebo-controlled Rotavirus Vaccine study. Ann Acad Med Singapore. 37(7):546-553.
Buyse H et al. (2013) The human rotavirus vaccine Rotarix™ in infants: An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 10(1). 19-24.
De Vos B et al. (2004) A Rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 23(10):179-182.
Phua KB et al. (2008) Immunogenicity, reactogenicity and safety of a diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus Influenzae type b combination vaccine in a placebo-controlled Rotavirus vaccine study. Ann Acad Med Singapore. 37(7):546-553.
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
January 2001 to April 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
11 - 17 weeks
Accepts healthy volunteers
Yes
- Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born
- after a normal gestation period (between 36 and 42 weeks).
- Use of any investigational or non-registered drug or vaccine other than the
- study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
- Written informed consent obtained from the parents or guardians of the subject.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
- Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- Household contact with an immunosuppressed individual or pregnant woman.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Previous confirmed occurrence of RV GE.
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2003-30-04
Actual study completion date
2003-30-04
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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Additional information
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