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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Rotavirus

Treatments: Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV); Biological: Infanrix™; Biological: GSK Biologicals' liquid human rotavirus vaccine 444563; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01171963

113808

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,340 patients

Sex: All

Ages: 6 to 16 weeks old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,340 participants in 2 patient groups, including a placebo group

Rotarix Group

Experimental group

Description:

Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.

Treatment:

Biological: GSK Biologicals' liquid human rotavirus vaccine 444563

Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)

Biological: Infanrix™

Placebo Group

Placebo Comparator group

Description:

Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.

Treatment:

Biological: Placebo

Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)

Biological: Infanrix™