Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers

NCT ID: NCT00920439

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-01
• Study Completion Date: 2009-08-03

Brief Summary

The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.

Conditions

Poliomyelitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

POLIORIX GROUP

Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix™ vaccine that was administrated into the upper right thigh by intramuscular injection (IM).

Group Type: EXPERIMENTAL

PoliorixTM

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

Interventions

PoliorixTM

Single dose, intramuscular administration.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
• Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
• Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Written informed consent obtained from the parent or guardian 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 within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination
• 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 and/or Hib vaccine(s).
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, 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
• Previous booster vaccination against poliomyelitis since the end of the primary vaccination series.
• History of poliomyelitis disease.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

• 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

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: Clinical Study Report

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: 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

Document Type: Dataset Specification

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

112683

Identifier Type: -

Identifier Source: org_study_id