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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.

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ClinicalTrials.gov Identifier: NCT00610168
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : March 30, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE January 25, 2008
First Posted Date  ICMJE February 7, 2008
Results First Submitted Date  ICMJE February 9, 2017
Results First Posted Date  ICMJE March 30, 2017
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE January 1, 2008
Actual Primary Completion Date April 30, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs [ Time Frame: At Month 0 ]
    The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
  • Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs [ Time Frame: At Month 1 ]
    The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • Anti-diphtheria antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-tetanus antibody concentrations [ Time Frame: One month after the booster dose ]
Change History Complete list of historical versions of study NCT00610168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations [ Time Frame: At Month 0 (PRE) and Month 1 (POST) ]
    Concentrations are presented as international units per millilitre (IU/mL).
  • Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) [ Time Frame: At Month 0 (PRE) and Month 1 (POST) ]
    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)
  • Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [ Time Frame: At Month 0 (PRE) and Month 1 (POST) ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
  • Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) [ Time Frame: At Month 1 ]
    Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster 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 0-3) follow-up period after booster 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 Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster 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.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • Anti-diphtheria antibody concentration
  • Anti-tetanus antibody concentrations
  • Anti-PT, anti-FHA and anti-PRN seropositivity
  • Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations
  • Booster response to the PT, FHA and PRN antigens
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period ]
  • Occurrence of serious adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
Official Title  ICMJE Evaluation of GSK Biologicals' dTpa Booster Vaccine in Young Adults 10 Years After Previous dTpa Boosting.
Brief Summary The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
Detailed Description This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Acellular Pertussis
  • Tetanus
  • Diphtheria
Intervention  ICMJE Biological: Boostrix TM
Single booster dose of vaccine
Other Name: dTpa vaccine
Study Arms  ICMJE
  • Experimental: BOOSTRIX I GROUP
    Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
    Intervention: Biological: Boostrix TM
  • Experimental: BOOSTRIX II GROUP
    Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
    Intervention: Biological: Boostrix TM
Publications *
  • He Q et al. Immunity to pertussis 10 years after acellular booster vaccine in adolescence and response to a second dTpa booster in young adults. Abstract presented at the 19th annual european congress of clinical microbiology and infectious diseases, Helsinki, Finland, 16-19 May 2009.
  • Mertsola J, Van Der Meeren O, He Q, Linko-Parvinen A, Ramakrishnan G, Mannermaa L, Soila M, Pulkkinen M, Jacquet JM. Decennial administration of a reduced antigen content diphtheria and tetanus toxoids and acellular pertussis vaccine in young adults. Clin Infect Dis. 2010 Sep 15;51(6):656-62. doi: 10.1086/655825.
  • Mertsola J et al. Decennial administration of reduced-antigen dTpa vaccine in young adults - incidence of solicited local symptoms classified by pre-vaccination antibody concentrations. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
  • Mertsola J et al. The immunogenicity and safety of repeated administration of dTpa booster in adolescents and young adults. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
  • Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009
  • Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
  • Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2009)
82
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2008)
509
Actual Study Completion Date  ICMJE April 30, 2008
Actual Primary Completion Date April 30, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004.
  • A male or female subject, recruited 10 years after booster vaccination in study 263855/004.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of 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.
  • Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004.
  • History of documented diphtheria, tetanus, or pertussis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • 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 7 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 (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
    • convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00610168
Other Study ID Numbers  ICMJE 110806
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP