Study to Evaluate the Safety of Rotarix™ in Chinese Children

NCT01086436 | Completed Phase 1

• 1 other identifier: 113552
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Rotavirus

Keywords

Human Rotavirus vaccine

Outcome Measures

Primary Outcomes (1)

• Occurrence of each solicited symptom

  Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose.

Secondary Outcomes (2)

• Occurrence of unsolicited adverse events

  Within the 31 days (Day 0 - Day 30) after the vaccine dose.

• Occurrence of serious adverse events

  Throughout the study period following the vaccine dose.

Study Arms (2)

Rotavirus Group

EXPERIMENTAL

Subjects will receive Rotarix™

Biological: Rotarix ™

Placebo Group

PLACEBO COMPARATOR

Subjects will receive placebo.

Biological: Placebo

Interventions

Rotarix ™ BIOLOGICAL

Oral, single dose

Rotavirus Group

Placebo BIOLOGICAL

Oral, single dose

Placebo Group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Liucheng County, Guangxi, 545200, China

Location

Related 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.

  PMID: 23807360 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Rotavirus Infections

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: March 13, 2010
• Primary Completion: April 16, 2010
• Study Completion: April 16, 2010
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)