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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058

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ClinicalTrials.gov Identifier: NCT00548171
Recruitment Status : Completed
First Posted : October 23, 2007
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE October 22, 2007
First Posted Date  ICMJE October 23, 2007
Results First Submitted Date  ICMJE May 22, 2017
Results First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE November 5, 2007
Actual Primary Completion Date April 30, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL) [ Time Frame: One month after the booster vaccination [PI(M1)] ]
Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
one month after the booster dose: anti-diphtheria and anti-tetanus antibody concentration
Change History Complete list of historical versions of study NCT00548171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values [ Time Frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination ]
    Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL.
  • Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination ]
    Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
  • Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values [ Time Frame: Prior (PRE) to booster vaccination ]
    Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and ≥ 1 IU/mL. This endpoint presents results for subjects included in the ATP cohort for antibody persistence.
  • Anti-DT and Anti-TT Antibody Concentrations [ Time Frame: Prior to the booster vaccination ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
  • Number of Seronegative Subjects for Anti-DT Antibodies - ELISA [ Time Frame: Prior the booster vaccination ]
    Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
  • Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test [ Time Frame: Prior the booster vaccination ]
    Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
  • Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies [ Time Frame: Prior the booster vaccination ]
    Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.
  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: Prior the booster vaccination ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL)
  • Number of Seronegative Subjects for Anti-DT Antibodies - ELISA. [ Time Frame: Prior to the booster vaccination ]
    Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
  • Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test. [ Time Frame: Prior to the booster vaccination ]
    Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
  • Number of Seronegative Subjects for Anti-DT Antibodies - ELISA [ Time Frame: One month after the booster vaccination ]
    Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
  • Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test [ Time Frame: One month after the booster vaccination ]
    Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥ 0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
  • Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies [ Time Frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination ]
    Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.
  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination ]
    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-PT, Anti-FHA and Anti-PRN [ Time Frame: One month after the booster vaccination ]
    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 pre-vaccination 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. Relationship analysis was not performed. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
  • 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, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. 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. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
  • Number of Subjects With Any 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Following the booster vaccination ]
    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. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
anti-diphtheria, anti-tetanus, anti-pertussis antibody conc (before and 1 month post vacc) sol (4 days) and unsol (31 days) symptoms, SAEs
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 in Study NCT01267058
Official Title  ICMJE Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 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 previous clinical study (NCT01267058). Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No new recruitment will be performed in this booster phase (see inclusion criteria).

Detailed Description Not Provided
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™
Intramuscular injection, 1 dose
Study Arms  ICMJE
  • Experimental: Boostrix I Group
    Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.
    Intervention: Biological: Boostrix™
  • Active Comparator: Boostrix II Group
    Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
    Intervention: Biological: Boostrix™
Publications *

*   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: July 20, 2018)
203
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2007)
550
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 263855/002 .
  • A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination in study 263855/002.
  • 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 be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of booster vaccination.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster 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 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 diphtheria, tetanus or pertussis since the last dose received in study 263855/002
  • History of 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 (axillary temperature) 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.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00548171
Other Study ID Numbers  ICMJE 110804
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 July 2018

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