Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

NCT ID: NCT01323647

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 957 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-25
• Study Completion Date: 2011-09-19

Brief Summary

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

Detailed Description

All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.

Group Type: EXPERIMENTAL

PoliorixTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration

Infanrix+Hib

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Group B

Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.

Group Type: ACTIVE_COMPARATOR

Infanrix+Hib

Intervention Type: BIOLOGICAL

Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Interventions

PoliorixTM

Single dose, intramuscular administration

Intervention Type: BIOLOGICAL

Infanrix+Hib

Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.
• Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
• Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
• 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.

Exclusion Criteria

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
• Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) 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.
• Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
• 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.
• Major congenital defects or serious chronic illness.
• Acute disease and/or fever at the time of enrolment.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Wuzhou, Guangxi, China

GSK Investigational Site

Mengshan Town, , China

Countries

China

References

Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.

Reference Type: DERIVED

PMID: 26873055 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

114306

Identifier Type: -

Identifier Source: org_study_id