Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults
Evaluation of GSK Biologicals' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination
1 other identifier
interventional
212
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2011
Shorter than P25 for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 28, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
August 3, 2017
CompletedJune 6, 2018
April 1, 2017
11 months
March 24, 2011
February 7, 2017
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).
At Month 1
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
At Month 1
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)
At Day 0
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
At Day 0
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
At Day 0
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
At Day 0
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Titers are presented as geometric mean titers (GMTs).
At Day 0
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)
At Day 0
Secondary Outcomes (9)
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
At Month 1
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
At Month 1
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
At Month 1
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
At Month 1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
At Month 1
- +4 more secondary outcomes
Study Arms (3)
BOOSTRIX POLIO GROUP
EXPERIMENTALHealthy 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.
BOOSTRIX+POLIORIX GROUP
EXPERIMENTALHealthy 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.
REVAXIS GROUP
EXPERIMENTALHealthy 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.
Interventions
Single dose, intramuscular administration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Derval, 44590, France
GSK Investigational Site
La Chapelle-Basse-Mer, 44450, France
GSK Investigational Site
La Riche, 37250, France
GSK Investigational Site
Nantes, 44277, France
GSK Investigational Site
Nantes, 44300, France
GSK Investigational Site
Tours, 37000, France
GSK Investigational Site
Tours, 37200, France
GSK Investigational Site
Deggendorf, Bavaria, 94469, Germany
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635, Germany
GSK Investigational Site
Munich, Bavaria, 80337, Germany
GSK Investigational Site
Regensburg, Bavaria, 93053, Germany
GSK Investigational Site
Selbitz, Bavaria, 95152, Germany
GSK Investigational Site
Vilshofen, Bavaria, 94474, Germany
GSK Investigational Site
Weilheim, Bavaria, 82362, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
Related Publications (1)
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.
PMID: 25882172DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 28, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 6, 2018
Results First Posted
August 3, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.