Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants

NCT ID: NCT00937404

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-04
• Study Completion Date: 2009-11-13

Brief Summary

The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.

Conditions

Poliomyelitis

Keywords

IPV

Study Design

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

Study Groups

IPV Group

Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, receive 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.

Group Type: EXPERIMENTAL

Poliorix

Intervention Type: BIOLOGICAL

All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.

Interventions

Poliorix

All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.

Intervention Type: BIOLOGICAL

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 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(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 allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• 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: 60 Days
• Maximum Eligible Age: 90 Days
• 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: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Other Identifiers

112581

Identifier Type: -

Identifier Source: org_study_id