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Study to Evaluate the Safety of Rotarix™ in Chinese Children

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ClinicalTrials.gov Identifier: NCT01086436
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Infections, Rotavirus Biological: Rotarix ™ Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reactogenicity and Safety of a Single Dose of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563) in Healthy Children
Actual Study Start Date : March 13, 2010
Actual Primary Completion Date : April 16, 2010
Actual Study Completion Date : April 16, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rotavirus Group
Subjects will receive Rotarix™
Biological: Rotarix ™
Oral, single dose

Placebo Comparator: Placebo Group
Subjects will receive placebo.
Biological: Placebo
Oral, single dose




Primary Outcome Measures :
  1. Occurrence of each solicited symptom [ Time Frame: Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose. ]

Secondary Outcome Measures :
  1. Occurrence of unsolicited adverse events [ Time Frame: Within the 31 days (Day 0 - Day 30) after the vaccine dose. ]
  2. Occurrence of serious adverse events [ Time Frame: Throughout the study period following the vaccine dose. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086436


Locations
China, Guangxi
GSK Investigational Site
Liucheng County, Guangxi, China, 545200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113552
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113552
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113552
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113552
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113552
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113552
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01086436     History of Changes
Other Study ID Numbers: 113552
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Human Rotavirus vaccine

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases