Clinical trial NCT01171963: Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: Liquid human retrovirus vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-29
Enrollment: 3340
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Subjects can receive routine childhood vaccination according to the expanded program of immunisation recommendations in China.

There will be two treatment groups (liquid human rotavirus vaccine and placebo). The study will also have two immunogenicity subgroups comprising of few subjects from both the treatment groups. The immunogenicity subgroup 1 will assess the immunogenicity of the liquid human rotavirus vaccine and the immunogenicity subgroup 2 will assess the immunogenicity of liquid human rotavirus vaccine and also the immunogenicity of oral poliovirus vaccine and diphtheria tetanus and acellular pertussis vaccine given concomitantly with liquid human rotavirus vaccine or placebo.

This protocol posting has been updated following the Protocol Amendment 2, dated 05 August 2011. The impacted section in the protocol posting is: Outcome Measures Section.

Eligibility 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.

Primary outcomes:
measure: 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:
measure: 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
measure: Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.
timeFrame: From Month 1 ½ to Month 21
measure: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.
timeFrame: From Month 1 ½ to Month 21
measure: 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
measure: Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause
timeFrame: From Month 1 ½ to Month 21
measure: 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
measure: 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
measure: 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
measure: 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
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: Throughout the entire study period (from Day 0 to Study End at Month 21)
measure: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies
timeFrame: At Month 2 and at 12 months of age
measure: Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.
timeFrame: At Month 2 and at 12 months of age
measure: 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
measure: Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations
timeFrame: At Day 0, Month 2 and at 12 months of age
measure: Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.
timeFrame: At Day 0, Month 2 and at 12 months of age.
measure: Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.
timeFrame: At Day 0, Month 2 and at 12 months of age
measure: Number of Subjects Seroprotected Against Diphtheria and Tetanus
timeFrame: At Day 0 and at Month 4
measure: Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
timeFrame: At Day 0 and at Month 4
measure: Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3.
timeFrame: At Day 0 and at Month 4
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Hechi
country: China
facility: GSK Investigational Site
state: Guangxi
city: Liucheng County
country: China
facility: GSK Investigational Site
state: Guangxi
city: Liuzhou
country: China
facility: GSK Investigational Site
state: Guangxi
city: Luzhai County
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Li RC, Huang T, Li Y, Luo D, Tao J, Fu B, Si G, Nong Y, Mo Z, Liao X, Luan I, Tang H, Rathi N, Karkada N, Han HH. Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: a randomized, placebo-controlled trial in China. Hum Vaccin Immunother. 2014;10(1):11-8. doi: 10.4161/hv.26319. Epub 2013 Sep 6.
citation: Li RC, Li YP, Mo ZJ, Luo D, Huang T, Kong JL, Wang LH, Song NS, Liu A, Zhang H, Liao X, Karkada N, Han HH. Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies. Hum Vaccin Immunother. 2013 Aug;9(8):1638-42. doi: 10.4161/hv.25076. Epub 2013 Jun 4.