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Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162590
First Posted: July 14, 2010
Last Update Posted: May 19, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
July 13, 2010
July 14, 2010
May 19, 2017
March 1, 2010
March 31, 2010   (Final data collection date for primary outcome measure)
Occurrence of each solicited symptom [ Time Frame: Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose ]
Occurrence of each solicited symptom [ Time Frame: Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose. ]
Complete list of historical versions of study NCT01162590 on ClinicalTrials.gov Archive Site
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after the vaccine dose ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the study period following the vaccine dose ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after the vaccine dose ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the study period following the vaccine dose. ]
Not Provided
Not Provided
 
Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults
Reactogenicity and Safety of a Single Dose of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563) in Healthy Adults
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy adults aged 18 to 45 years in China.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infections, Rotavirus
  • Biological: Rotarix ™
    Oral, single dose
  • Biological: Placebo
    Oral, single dose
  • Experimental: Rotarix Group
    Subjects will receive Rotarix™.
    Intervention: Biological: Rotarix ™
  • Placebo Comparator: Placebo Group
    Subjects will receive placebo.
    Intervention: Biological: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
March 31, 2010
March 31, 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01162590
113545
Not Provided
Not Provided
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP