Last updated: 12/26/2019 11:40:07
Evaluate protective efficacy of diff strengths of human rotavirus vaccine after admn of 2 doses to infants aged 2 months
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: To assess the efficacy, immuno & safety of 2 doses of GSK HRV vaccine at different virus concentrations in healthy infants aged 2 months & previously uninfected with HRV, concurrently given with DTPw-HBV, Hib.
Trial description: The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
2640
Primary completion date:
2003-30-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Araujo EC et al. (2007) Safety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy Brazilian infants. J Pediatr (Rio J). 83 (3):217-224.
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.
Cheuvart B et al. (2014) Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: Analysis of clinical trials of human rotavirus vaccine. Hum Vaccin Immunother. 10(2):505–511.
De Vos B et al. (2004) A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 23 (Supplement 10): S179-S182.
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.
Linhares AC et al. (2006) A short report on highlights of world-wide development of RIX4414: a Latin American experience. Vaccine. 24 (18):3784-3785.
Linhares AC et al. (2006) Rotavirus serotype G9 is associated with more severe disease in Latin America. Clin Infect Dis.43(3):312-314.
Perez-Schael I et al. (2007) Efficacy of the human rotavirus vaccine RIX4414 in malnourished children. J Infect Dis. 196(4):537-540.
Ruiz-Palacios GM et al. (2007) Dose response and efficacy of a live attenuated human rotavirus vaccine in Mexican Infants. Pediatrics. 120(2):253-261.
Salinas B et al. (2005) Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J. 24 (9):807-816.
Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1) Supplement: S28-S32.
Medical condition
Infections, Rotavirus
Product
Rotavirus Vaccine
Collaborators
Not applicable
Study date(s)
May 2001 to April 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.
- Written informed consent obtained from the parent or guardian of the subject.
- Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion criteria:
- Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
- Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
- History of allergic disease
- 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.
- Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
- Previous confirmed occurrence of RV GE.
- Household contact with an immunosuppressed individual or pregnant women.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
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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