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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323959
First Posted: March 28, 2011
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Acellular Pertussis Poliomyelitis Diphtheria Tetanus Biological: BoostrixTM Polio Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of GSK Biologicals' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens [ Time Frame: At Month 1 ]
    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).

  • Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: At Month 1 ]
    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)

  • Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens [ Time Frame: At Day 0 ]
    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)

  • Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: At Day 0 ]
    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)

  • Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies [ Time Frame: At Day 0 ]
    Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)

  • Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [ Time Frame: At Day 0 ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)

  • Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers [ Time Frame: At Day 0 ]
    Titers are presented as geometric mean titers (GMTs).

  • Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations [ Time Frame: At Day 0 ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)


Secondary Outcome Measures:
  • Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) [ Time Frame: At Month 1 ]
    Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration.

  • Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off [ Time Frame: At Month 1 ]
    Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)

  • Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [ Time Frame: At Month 1 ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)

  • Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers [ Time Frame: At Month 1 ]
    Titers are presented as geometric mean titers (GMTs).

  • Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations [ Time Frame: At Month 1 ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after vaccination ]
    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: Month 0 - Month 1 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 212
Study Start Date: April 1, 2011
Study Completion Date: March 1, 2012
Primary Completion Date: March 1, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: BoostrixTM Polio
Single dose, intramuscular administration.
Experimental: 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.
Biological: BoostrixTM Polio
Single dose, intramuscular administration.
Experimental: 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.
Biological: BoostrixTM Polio
Single dose, intramuscular administration.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323959


Locations
France
GSK Investigational Site
Derval, France, 44590
GSK Investigational Site
La Chapelle Basse Mer, France, 44450
GSK Investigational Site
La Riche, France, 37250
GSK Investigational Site
Nantes cedex 2, France, 44277
GSK Investigational Site
Nantes, France, 44300
GSK Investigational Site
Tours, France, 37000
GSK Investigational Site
Tours, France, 37200
Germany
GSK Investigational Site
Deggendorf, Bayern, Germany, 94469
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
GSK Investigational Site
Muenchen, Bayern, Germany, 80337
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Selbitz, Bayern, Germany, 95152
GSK Investigational Site
Vilshofen, Bayern, Germany, 94474
GSK Investigational Site
Weilheim, Bayern, Germany, 82362
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113060
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113060
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113060
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113060
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113060
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113060
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323959     History of Changes
Other Study ID Numbers: 113060
First Submitted: March 24, 2011
First Posted: March 28, 2011
Results First Submitted: February 7, 2017
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
BoostrixTM Polio
dTpa-IPV
booster

Additional relevant MeSH terms:
Diphtheria
Poliomyelitis
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs