Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rotavirus Gastroenteritis	Biological: GSK Biologicals' liquid human rotavirus vaccine 444563 Biological: Placebo Biological: Infanrix™ Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Boostrix Rotarix Adacel Poliovirus Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of severe rotavirus gastroenteritis caused by the circulating wild-type rotavirus strains in subjects vaccinated with liquid human rotavirus vaccine/placebo. [ Time Frame: Two weeks post-dose 2 of liquid human rotavirus vaccine/placebo till April 2012 (i.e. end of RV season in China). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of any and severe rotavirus gastroenteritis caused by G1 and each non G1 type of rotavirus in subjects vaccinated with liquid human rotavirus vaccine/placebo. [ Time Frame: Two weeks post-dose 2 of liquid human rotavirus vaccine/placebo till April 2012 (i.e. end of RV season in China). ] [ Designated as safety issue: No ]
Occurrence of any and severe all cause gastroenteritis. [ Time Frame: Two weeks post-dose 2 of liquid human rotavirus vaccine/placebo till April 2012 (i.e. end of RV season in China). ] [ Designated as safety issue: No ]
Anti-rotavirus Immunoglobulin A antibody concentrations in the immunogenicity subgroup 1. [ Time Frame: One month post-dose 2 of liquid human rotavirus vaccine/placebo and when the subject attains one year of age. ] [ Designated as safety issue: No ]
Anti-rotavirus Immunoglobulin A antibody concentrations in the immunogenicity subgroup 2. [ Time Frame: One month post-dose 2 of liquid human rotavirus vaccine/placebo and when the subject attains one year of age. ] [ Designated as safety issue: No ]
Immunogenicity against all antigens contained in each co-administered childhood vaccine in the immunogenicity subgroup 2. [ Time Frame: 2 months post-dose 3 of OPV vaccine and 1 month post-dose 3 of DTPa vaccine. ] [ Designated as safety issue: No ]
Occurrence of each general solicited symptom specific to liquid human rotavirus vaccine in all subjects except those in the immunogenicity subgroup 2. [ Time Frame: Within the 8-day (Day 0 - Day 7) follow-up period after each dose of liquid human rotavirus vaccine/placebo. ] [ Designated as safety issue: No ]
Occurrence of local and general solicited symptoms specific to co-administered vaccines in immunogenicity subgroup 2. [ Time Frame: Within the 8-day (Day 0 - Day 7) follow-up period after the Dose 1 and Dose 2 of Oral Poliovirus vaccine and after Dose 1 of Diphtheria Tetanus and acellular Pertussis Vaccine. ] [ Designated as safety issue: No ]
Occurrence of unsolicited symptoms in all subjects. [ Time Frame: Within the 31-day (Day 0 - Day 30) follow-up period after any dose of liquid human rotavirus vaccine or placebo. ] [ Designated as safety issue: No ]
Occurrence of Serious Adverse Events in all subjects. [ Time Frame: Throughout the study period (Day 0 to April 2012 [i.e. end of RV season in China]). ] [ Designated as safety issue: No ]
Occurrence of any and hospitalised rotavirus gastroenteritis caused by circulating wild type rotavirus in subjects vaccinated with liquid human rotavirus vaccine/placebo. [ Time Frame: Two weeks post-dose 2 of liquid human rotavirus vaccine/placebo till April 2012 (i.e. end of RV season in China). ] [ Designated as safety issue: No ]

Enrollment:	3340
Study Start Date:	August 2010
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Not Applicable	Biological: GSK Biologicals' liquid human rotavirus vaccine 444563 Oral administration Biological: Infanrix™ Intramuscular administration Other Name: DTPa Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV) Oral administration
Placebo Comparator: Group B Not Applicable	Biological: Placebo Oral administration Biological: Infanrix™ Intramuscular administration Other Name: DTPa Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV) Oral administration

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

Ages Eligible for Study:	6 Weeks to 16 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171963

Locations

China, Guangxi
GSK Investigational Site
Hechi, Guangxi, China, 547000
GSK Investigational Site
Liucheng County, Guangxi, China, 545200
GSK Investigational Site
Liuzhou, Guangxi, China, 545100
GSK Investigational Site
Luzhai County, Guangxi, China, 545600

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01171963 History of Changes
Other Study ID Numbers:	113808
Study First Received:	July 28, 2010
Last Updated:	July 26, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Liquid human retrovirus vaccine

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013