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Trial record 1 of 2 for:    rotarix | Rotavirus Infections | Phase 1
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Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162590
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy adults aged 18 to 45 years in China.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Adults
Actual Study Start Date : March 1, 2010
Actual Primary Completion Date : March 31, 2010
Actual Study Completion Date : March 31, 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rotarix Group
Subjects will receive Rotarix™.
 Biological: Rotarix ™
Oral, single dose
Placebo Comparator: Placebo Group
Subjects will receive placebo.
 Biological: Placebo
Oral, single dose


Outcome Measures
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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 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female subject of Chinese origin, 18 years to 45 years inclusive of age at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.
  • Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception.
  • Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. Planned administration/ administration of a vaccine not foreseen by the study protocol within 14 days of the study vaccine or placebo and ending 14 days after.
  • 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
  • Administration of immunoglobulins and/ or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/ or drug abuse.
Contacts and Locations
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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): NCT01162590


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

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113545
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113545
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113545
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113545
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: 113545
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: 113545
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01162590    
Other Study ID Numbers: 113545
First Posted: July 14, 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:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Infections