Last updated: 11/07/2018 14:27:01
A study to test 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants
Trial description: The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
10708
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Guillermo M et al. RIX4414 (Rotarix™) has demonstrated efficacy during the first 2 years of life in infants from 11 Latin American countries. Abstract presented at the 10th International Rotavirus Symposium (IRS), Bangkok, Thailand, 19-21 Sep 2012.
Lau YL et al. (2013) Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial. Vaccine. 31(18):2253-2259. doi: 10.1016/j. vaccine. 2013.03.001.
Phua KB et al. (2009) Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: Randomised, double-blind, controlled study. Vaccine. 27(43):5936-5941.
Phua KB et al. Efficacy of rotavirus vaccine RIX4414 during the first 3 years of life: a randomised, double-blind, placebo-controlled study in infants from Hong Kong, Singapore and Taiwan. Abstract presented at the 10th International Rotavirus Symposium (IRS), Bangkok, Thailand, 19-21 Sep 2012.
Phua KB et al. Human rotavirus vaccine RIX4414 (Rotarix™) is highly efficacious in Asian infants during the first three years of life. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.
Phua KB et al. Human rotavirus vaccine RIX4414 (Rotarix™) is highly efficacious in infants from Asia during the first two years of life. Abstract presented at the 13th International Congress on Infectious Diseases (ICID). Kuala Lumpur, Malaysia, 19-22 June 2008.
Phua KB et al. Human rotavirus vaccine RIX4414 is highly efficacious in Asian infants during the third year of life. Abstract presented at the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Brussels, Belgium, 9-13 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.
Han HH et al. (2017) Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis. Hum Vaccin Immunother. 3(1):237-244.
Lau YL et al. (2013) Efficacy, safety and immunogenicity of a human rotavirus vaccine (RIX4414) in Hong Kong children up to three years of age: a randomized, controlled trial. Vaccine. 31(18):2253-2259.
Phua KB et al. (2012) Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: a randomized clinical trial in an Asian population. Vaccine. 30(30):4552-4557.
Phua KB et al. (2016) Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants. Ann Acad Med Singapore. 45(2); 44-50.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
December 2003 to July 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 17 weeks
Accepts healthy volunteers
Yes
- Inclusion criteria:
- Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Healthy infants 6-12 or 11-17 weeks of age at the time of dose 1 whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol. Exclusion criteria:
- 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 placebo, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Child is unlikely to remain in the study area during study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- First or second degree of consanguinity of parents.
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-28-07
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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