Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants

GlaxoSmithKline1 site in 1 country1,101 target enrollmentNovember 28, 2009

ConditionsPoliomyelitis Poliomyelitis Vaccines

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Poliomyelitis
Sponsor: GlaxoSmithKline
Enrollment: 1101
Locations: 1
Primary Endpoint: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.

Registry

clinicaltrials.gov

Start Date

November 28, 2009

End Date

July 5, 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
•Born after a gestation period of 36 to 42 weeks inclusive.
•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR) (s) can and will comply with the requirements of the protocol.
•Written informed consent obtained from the parent(s)/LAR(s) 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(s) 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.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
•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.
•Evidence of previous or intercurrent poliomyelitis disease or vaccination.
•History of seizures or progressive neurological disease.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Major congenital defects or serious chronic illness.

Outcomes

Primary Outcomes

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3

Time Frame: At Month 3, one month after the third vaccine dose

A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).

Secondary Outcomes

Anti-poliovirus Types 1, 2 and 3 Antibody Titers(Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3))
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3(At Day 0, prior to the first vaccine dose)
Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 31-day (Days 0-30) post-vaccination period)
Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to Month 3))
Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses)