Study to Evaluate the Safety of Rotarix™ in Chinese Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-13

Study Completion Date

2010-04-16

Brief Summary

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The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.

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Detailed Description

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Conditions

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Infections, Rotavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rotavirus Group

Subjects will receive Rotarix™

Group Type EXPERIMENTAL

Rotarix ™

Intervention Type BIOLOGICAL

Oral, single dose

Placebo Group

Subjects will receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Oral, single dose

Interventions

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Rotarix ™

Oral, single dose

Intervention Type BIOLOGICAL

Placebo

Oral, single dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that their parents/guardians (Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female subject of Chinese origin, between, and including, 2 and 6 years of age at the time of vaccination.
* Written informed consent obtained from the parent or legally acceptable representative of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs six months prior to the vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 14 days of the Human Rotavirus vaccine or placebo with the exception of the routine childhood vaccines. Routine childhood vaccines must not be administered on the same day as the Human Rotavirus vaccine or placebo.
* Administration of immunoglobulins and/or any blood products since birth within three months preceding the study vaccine or planned administration during the study period.
* Major congenital defects or serious chronic illness.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of Intusussception or any chronic gastrointestinal disease that would predispose for Intusussception including any uncorrected congenital malformation of the gastrointestinal tract.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
* 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..
* Child in care.

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Liucheng County, Guangxi, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND

PMID: 23807360 (View on PubMed)

Study Documents

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