Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants

Reactogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine 444563, in Healthy Infants

The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.

Study Overview

• Status: Completed
• Conditions: Infections, Rotavirus
• Intervention / Treatment: Biological: GSK Biologicals' human rotavirus vaccine 444563; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Liucheng County, Guangxi, China, 545200
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth (for corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
• Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment..
• History of confirmed rotavirus gastroenteritis.
• Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
• Previous vaccination with rotavirus vaccine or planned to use during the study period.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Subjects will receive placebo.	Biological: Placebo; Oral, two doses.
Experimental: HRV group; Subjects will receive GSK Biologicals' human rotavirus vaccine 444563.	Biological: GSK Biologicals' human rotavirus vaccine 444563; Oral, two doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of grade 3 solicited adverse events.	Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of each solicited adverse event.	Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Occurrence of unsolicited adverse events.	Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose.
Occurrence of serious adverse events.	Throughout the study period (Day 0 to Month 2).

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2010
• Primary Completion (Actual): June 28, 2010
• Study Completion (Actual): June 28, 2010

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Human rotavirus vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections
• Other Study ID Numbers: 113518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Dataset Specification
   Information identifier: 113518
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 113518
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 113518
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: 113518
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 113518
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 113518
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register