Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants

Study Overview
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Brief Summary
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The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.

Official Title
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Reactogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine 444563, in Healthy Infants

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Biological: GSK Biologicals' human rotavirus vaccine 444563
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) 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 parent(s)/ Legally Acceptable Representative(s) 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 (for corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed). Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations. Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. Acute disease at the time of enrolment.. History of confirmed rotavirus gastroenteritis. Gastroenteritis within 7 days preceding the study vaccine or placebo administration. Previous vaccination with rotavirus vaccine or planned to use during the study period. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. 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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 16 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRV group<br>Subjects will receive GSK Biologicals' human rotavirus vaccine 444563. | Biological: GSK Biologicals' human rotavirus vaccine 444563<br>* Oral, two doses.<br>|
| Placebo Comparator: Placebo Group<br>Subjects will receive placebo. | Biological: Placebo<br>* Oral, two doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of grade 3 solicited adverse events. |  | Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of each solicited adverse event. |  | Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. | 
| Occurrence of unsolicited adverse events. |  | Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose. | 
| Occurrence of serious adverse events. |  | Throughout the study period (Day 0 to Month 2). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human rotavirus vaccine