Study to Evaluate the Safety of Rotarix™ in Chinese Children

Infections, Rotavirus Clinical Trial

Official title:

Reactogenicity and Safety of a Single Dose of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563) in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086436
• Other study ID #: 113552
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2010
• Last updated: May 18, 2017
• Start date: March 13, 2010
• Est. completion date: April 16, 2010

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 16, 2010
• Est. primary completion date: April 16, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• Rotarix ™
Oral, single dose
• Placebo
Oral, single dose

Locations

Country	Name	City	State
China	GSK Investigational Site	Liucheng County	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of each solicited symptom		Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose.
Secondary	Occurrence of unsolicited adverse events		Within the 31 days (Day 0 - Day 30) after the vaccine dose.
Secondary	Occurrence of serious adverse events		Throughout the study period following the vaccine dose.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 113552 can be found on the GSK Clinical Study Register