Last updated: 11/02/2018 23:50:20
Vaccine Efficacy against Rotavirus Diarrhea; Vaccine Given with Routine Childhood Vaccinations in Healthy African Infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
Trial description: The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5. The primary objective will be reached if the lower limit of the 95% confidence interval (CI) on vaccine efficacy is >0%.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with severe rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of age
Secondary outcomes:
Number of subjects with severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus strain, classified by rotavirus type
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of age
Number of subjects reporting any rotavirus gastroenteritis caused by the circulating wild-type rotavirus strain
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of age
Number of subjects with severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus strain
Timeframe: From the first vaccine or placebo dose up to 1 year of age
In South Africa, number of subjects with severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus strain
Timeframe: From 2 weeks after the third dose of vaccine or placebo up to 1 year of age
Number of subjects reporting severe gastroenteritis of any cause
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of age
Number of subjects hospitalized and/or with supervised re-hydration therapy due to rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of age
For subjects in Cohort 2 South Africa and the cohort in Malawi: Number of subjects with severe rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strains
Timeframe: During the period from 2 weeks after the last dose of vaccine or placebo until study end
For subjects in Cohort 2 South Africa and the cohort in Malawi: Number of subjects with severe rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strains
Timeframe: During the period from 1 year of age to study end
For subjects in Cohort 2 South Africa and the cohort in Malawi: Number of subjects hospitalized and/or with supervised re-hydration therapy due to rotavirus gastroenteritis (RV GE) episode caused by the circulating wild-type RV strains
Timeframe: During the period from 2 weeks after the last dose of vaccine or placebo until study end
For subjects in Cohort 2 South Africa and the cohort in Malawi: Number of subjects hospitalized and/or with supervised re-hydration therapy due to rotavirus gastroenteritis (RV GE) episode caused by the circulating wild-type RV strains
Timeframe: During the period from 1 year of age to study end
For subjects in Cohort 2 South Africa and the cohort in Malawi: Number of subjects with severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus strains, classified by rotavirus type
Timeframe: During the period from 2 weeks after the last dose of vaccine or placebo until study end
For subjects in Cohort 2 South Africa and the cohort in Malawi: Number of subjects with severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus strains, classified by rotavirus type
Timeframe: During the period from 1 year of age to study end
Number of subjects with adverse events (AEs) or serious adverse events (SAEs) leading to drop out
Timeframe: From the first dose of vaccine or placebo up to end of the study
Number of subjects reporting serious adverse events (SAEs)
Timeframe: From the first dose of vaccine or placebo up to end of the study
Geometric mean concentration of anti-rotavirus immunoglobulin A (IgA) antibodies in initially seronegative subjects
Timeframe: One month after the last vaccine dose
Number of seroconverted subjects
Timeframe: One month after the last vaccine or placebo dose
Geometric mean concentration of anti-rotavirus immunoglobulin A (IgA) antibodies
Timeframe: One month after the last vaccine or placebo dose
Number of seropositive subjects
Timeframe: One month after the last vaccine or placebo dose
Interventions:
Enrollment:
2089
Primary completion date:
2008-30-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cunliffe N et al. Efficacy of human rotavirus vaccine RIX4414 in Africa during the first year of life. Abstract presented at the 27th Annual Meeting of the European Society for Paediatric Infectious Disease (ESPID), Brussels, Belgium, 9-13 June 2009.
Cunliffe NA et al. (2012) Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian children in the first two years of life: A randomized, double-blind, placebo controlled trial. Vaccine. 30(1)36-43.
Cunliffe NA et al. Efficacy of Human Rotavirus Vaccine RIX4414 in Malawian Infants in the first two years of life. Abstract presented at the 6th African Rotavirus Symposium, Johannesburg, South Africa, 2‐3 August 2010.
Madhi S A et al. (2010) Effect of Human Rotavirus Vaccine on Severe Diarrhea in African Infants. N Eng J Med. 362(4): 289-298.
Madhi S et al. Efficacy of the human rotavirus vaccine RIX4414 against rotavirus G2P[4]/g8p[4] strains in South African infants. Abstract presented at the 6th world congress of the World Society for Pediatric Infectious Diseases (WSPID), Buenos Aires, Argentina, 18-22 November 2009.
Madhi SA et al (2012) Efficacy and immunogenicity of two or three dose rotavirus-vaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, double-blind, placebo-controlled trial. Vaccine. 30(1)44-51.
Nakagomi T et al. (2012) Molecular characterization of rotavirus strains detected during a clinical trial of a human rotavirus vaccine in Blantyre, Malawi. Vaccine. 30(1)140-151.
Neuzil K et al. Immunogenicity of human rotavirus vaccine RIX4414 in South African and Malawian infants. Abstract presented at the 6th world congress of the World Society for Pediatric Infectious Diseases (WSPID), Buenos Aires, Argentina, 18-22 November 2009.
Neuzil K et al. RIX4414 is protective against severe RVGE caused by diverse rotavirus serotypes during the first year of life in African infants. Abstract presented at the 27th Annual Meeting of the European Society for Paediatric Infectious Disease (ESPID), Brussels, Belgium, 9-13 June 2009.
Steele AD et al. Efficacy of human rotavirus vaccine, Rotarix™ against severe gastroenteritis caused by diverse circulating rotavirus strains in African infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
Steele D et al. Diverse circulating rotavirus strains during the first year of life in African infants. Abstract presented at 10th International symposium on dsRNA Viruses, Hamilton Island, QLD, Australia, 21-25 June 2009.
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.
Madhi SA et al. (2010) Effect of Human Rotavirus vaccine on severe diarrhea in African Infants. N Eng J Med. 362(4):289-298.
Steele AD et al. (2012) Human rotavirus vaccine Rotarix™ provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial. BMC Infect Dis. 12:213.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
October 2005 to June 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
5 - 10 weeks
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
- Use of any investigational or non-registered product (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.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
- Written informed consent obtained from the parent or guardian of the subject who is of legal age
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- In South Africa, birth weight > 2000 grams or if weight unknown, gestation period > 36 weeks.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
- Chronic administration (defined as more than 14 days) of immunosuppressants since birth.
- History of use of experimental rotavirus vaccine.
- Previous routine vaccination except Bacille Calmette-Guérin (BCG), hepatitis B virus (HBV) and oral poliovirus (OPV) vaccination at birth
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Gastroenteritis within 7 days preceding the first study vaccine administration
- Previous confirmed occurrence of rotavirus gastroenteritis (RV GE).
- A family history of congenital or hereditary immunodeficiency.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- History of any neurologic disorders or seizures.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Use of any investigational or non-registered product (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.
Trial location(s)
Location
GSK Investigational Site
Eldorado Park Ext 9, Soweto, South Africa
Status
Study Complete
Showing 1 - 6 of 13 Results
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
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-30-06
Actual study completion date
2008-30-06
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website