Last updated: 11/07/2018 06:56:17
Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Efficacy, immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in healthy infants
Trial description: The purpose of this study is to assess the efficacy, immunogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy Chinese infants 6 to 16 weeks of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with severe episode(s) of rotavirus gastroenteritis (RVGE) caused by the circulating wild type (WT) strains
Timeframe: From Month 1 ½ to Month 21
Secondary outcomes:
Number of subjects with any episode(s) of rotavirus gastroenteritis (RVGE) caused by the circulating wild-type strains
Timeframe: From Month 1 ½ to Month 21
Number of subjects with any episode(s) of rotavirus gastroenteritis (RVGE) of any type.
Timeframe: From Month 1 ½ to Month 21
Number of subjects with severe episode(s) of rotavirus gastroenteritis (RVGE) of any type.
Timeframe: From Month 1 ½ to Month 21
Number of subjects with episodes of rotavirus gastroenteritis (RVGE) caused by the circulating wild type (WT) strains requiring hospitalization
Timeframe: From Month 1 ½ to Month 21
Number of subjects with any and severe gastroenteritis (GE) due to any cause
Timeframe: From Month 1 ½ to Month 21
Number of subjects with any solicited general symptoms following vaccination with the Rotarix vaccine/placebo
Timeframe: Within the 8-day (Days 0–7) follow-up periods after any dose of Rotarix vaccine/placebo
Number of subjects with any solicited general symptoms following administration of the co-administered EPI vaccines
Timeframe: Within the 8-day (Days 0–7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix vaccine
Number of subjects with any solicited local symptoms following Dose 2 of the Rotarix vaccine/placebo
Timeframe: Within the 8-day (Days 0–7) follow-up periods following Dose 2 of the Rotarix vaccine/placebo
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Within the 31-day (Days 0–30) follow-up periods following any dose of the Rotarix vaccine or placebo
Number of subjects with any serious adverse events (SAEs)
Timeframe: Throughout the entire study period (from Day 0 to Study End at Month 21)
Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies
Timeframe: At Month 2 and at 12 months of age
Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies.
Timeframe: At Month 2 and at 12 months of age
Number of seroconverted subjects for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies.
Timeframe: At Month 2 and at 12 months of age
Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies.
Timeframe: At Day 0, Month 2 and at 12 months of age
Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies.
Timeframe: At Day 0, Month 2 and at 12 months of age
Number of subjects seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies.
Timeframe: At Day 0, Month 2 and at 12 months of age
Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations
Timeframe: At Day 0, Month 2 and at 12 months of age
Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations.
Timeframe: At Day 0, Month 2 and at 12 months of age.
Anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibody concentrations.
Timeframe: At Day 0, Month 2 and at 12 months of age
Number of subjects seroprotected against diphtheria and tetanus
Timeframe: At Day 0 and at Month 4
Anti-Diphtheria (Anti-D) and anti-tetanus (anti-T) antibody concentrations
Timeframe: At Day 0 and at Month 4
Number of subjects seroprotected against poliovirus types 1, 2 and 3.
Timeframe: At Day 0 and at Month 4
Titers for anti-poliovirus type 1 (anti-polio 1), anti-polio 2 and anti-polio 3 antibodies
Timeframe: At Day 0 and at Month 4
Number of subjects seropositive for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies.
Timeframe: At Day 0 and at Month 4
Concentrations of anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies
Timeframe: At Day 0 and at Month 4
Interventions:
Biological/vaccine: GSK Biologicals' liquid human rotavirus vaccine 444563
Biological/vaccine: Placebo
Biological/vaccine: Infanrix™
Biological/vaccine: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
Enrollment:
3340
Observational study model:
Not applicable
Primary completion date:
2012-12-05
Time perspective:
Not applicable
Clinical publications:
Li RC et al. (2013) Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: a randomized, placebo-controlled trial in China. Hum Vaccin Immunother. 10(1):1-8.
Li RC et al. (2015) Immunogenicity and reactogenicity of the human rotavirus vaccine, RIX4414 oral suspension, when co-administered with routine childhood vaccines in Chinese infants. Human Vaccines & Immunotherapeutics. DOI 10.1080/21645515.2015.1085143.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
August 2010 to May 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 16 weeks
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
- A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that their parents/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
- A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents/Legally Acceptable Representatives of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/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 the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
- 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.
- Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception .
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of confirmed rotavirus gastroenteritis.
- Acute disease and/or fever at the time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. In addition to the criteria mentioned above, the following criteria will be applicable to all subjects in the immunogenicity subgroup 2:
- History of diphtheria, tetanus and pertussis disease.
- History of seizures or progressive neurological disease.
- Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis.
Trial location(s)
Location
GSK Investigational Site
Liucheng County, Guangxi, China, 545200
Status
Study Complete
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
Completed
Actual primary completion date
2012-12-05
Actual study completion date
2012-12-05
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.
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