Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults

NCT ID: NCT01323959

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-01
• Study Completion Date: 2012-03-01

Brief Summary

This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.

Detailed Description

This protocol posting has been updated following protocol amendment 1, dated 03 June 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

Conditions

Acellular Pertussis; Poliomyelitis; Diphtheria; Tetanus

Study Design

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

Study Groups

BOOSTRIX POLIO GROUP

Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.

Group Type: EXPERIMENTAL

BoostrixTM Polio

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

BOOSTRIX+POLIORIX GROUP

Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.

Group Type: EXPERIMENTAL

BoostrixTM Polio

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

REVAXIS GROUP

Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.

Group Type: EXPERIMENTAL

BoostrixTM Polio

Intervention Type: BIOLOGICAL

Single dose, intramuscular administration.

Interventions

BoostrixTM Polio

Single dose, intramuscular administration.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Male or female subjects who have received vaccine in study NCT01277705.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject:

• practices/has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• agrees to continue adequate contraception during the entire booster epoch.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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 dose.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active 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.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Group C.
• History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
• Occurrence of any of the following adverse event after a previous administration of a DTP vaccine:

• Hypersensitivity reaction to any component of the vaccine,
• encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
• fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause,
• collapse or shock-like state within 48 hours of vaccination,
• convulsions with or without fever, occurring within 3 days of vaccination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Minimum Eligible Age: 25 Years
• 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

Derval, , France

GSK Investigational Site

La Chapelle-Basse-Mer, , France

GSK Investigational Site

La Riche, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Nantes, , France

GSK Investigational Site

Tours, , France

GSK Investigational Site

Tours, , France

GSK Investigational Site

Deggendorf, Bavaria, Germany

GSK Investigational Site

Höhenkirchen-Siegertsbrunn, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Regensburg, Bavaria, Germany

GSK Investigational Site

Selbitz, Bavaria, Germany

GSK Investigational Site

Vilshofen, Bavaria, Germany

GSK Investigational Site

Weilheim, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

Countries

France; Germany

References

Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.

Reference Type: DERIVED

PMID: 25882172 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

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: Individual Participant Data Set

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

Document Type: Clinical Study Report

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

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

113060

Identifier Type: -

Identifier Source: org_study_id