Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants

NCT ID: NCT00290342

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2007-01-23

Brief Summary

DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Participants in this Phase IIIb study will either receive GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or co-administration of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis (DTPa) vaccine and Sanofi-Pasteurs' inactivated poliovirus vaccine. Vaccines for both groups will be administered at 2, 4 and 6 months of age. Two blood samples will be collected during the course of the study: prior to vaccination and one month after the third vaccine dose.

Conditions

Tetanus; Acellular Pertussis; Diphtheria

Study Design

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

Study Groups

Infanrix-IPV Group

Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.

Group Type: EXPERIMENTAL

DTPa-IPV

Intervention Type: BIOLOGICAL

3 intramuscular injections

Infanrix + IMOVAX Polio Group

Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.

Group Type: ACTIVE_COMPARATOR

DTPa

Intervention Type: BIOLOGICAL

3 intramuscular injections

IMOVAX Polio®

Intervention Type: BIOLOGICAL

3 intramuscular injections

Interventions

DTPa-IPV

3 intramuscular injections

Intervention Type: BIOLOGICAL

DTPa

3 intramuscular injections

Intervention Type: BIOLOGICAL

IMOVAX Polio®

3 intramuscular injections

Intervention Type: BIOLOGICAL

Other Intervention Names

Infanrix™-IPV; Infanrix™

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
• A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of the first vaccination.
• 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.
• Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine.
• Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose.
• 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 (pharmaceutical product or device).
• Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease.
• History of diphtheria, tetanus, pertussis and/or poliovirus diseases.
• Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period.
• Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 12 Weeks
• 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

Bucheon-si, , South Korea

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Gwangju, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Jeonju, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

Countries

South Korea

Study Documents

Document Type: Study Protocol

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: 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: Statistical Analysis Plan

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

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

104871

Identifier Type: -

Identifier Source: org_study_id