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

NCT01107587 | Completed Phase 1

• 1 other identifier: 113518
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infections, Rotavirus

Keywords

Human rotavirus vaccine

Outcome Measures

Primary Outcomes (1)

• Occurrence of grade 3 solicited adverse events.

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

Secondary Outcomes (3)

• 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).

Study Arms (2)

HRV group

EXPERIMENTAL

Subjects will receive GSK Biologicals' human rotavirus vaccine 444563.

Biological: GSK Biologicals' human rotavirus vaccine 444563

Placebo Group

PLACEBO COMPARATOR

Subjects will receive placebo.

Biological: Placebo

Interventions

GSK Biologicals' human rotavirus vaccine 444563 BIOLOGICAL

Oral, two doses.

HRV group

Placebo BIOLOGICAL

Oral, two doses.

Placebo Group

Eligibility Criteria

• Age: 6 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

• 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 113518 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Rotavirus Infections

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: April 20, 2010
• First Posted: April 21, 2010
• Study Start: April 13, 2010
• Primary Completion: June 28, 2010
• Study Completion: June 28, 2010
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)