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Evaluation of Boostrix™10 Years After Previous Booster Vaccination

Primary Purpose

Acellular Pertussis, Tetanus, Diphtheria

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Boostrix™
Boostrix™-US formulation
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acellular Pertussis focused on measuring Immune persistence, Boostrix, dTpa booster study

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029.
  • Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
  • Healthy subjects as established by medical history and clinical examination.
  • Female subjects of non-childbearing potential may receive the booster vaccine.
  • Female subjects of childbearing potential may 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:

Exclusion criteria to be checked at study entry:

  • Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.
  • History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • 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 (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 three days of vaccination.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Additional exclusion criteria to be checked for subjects before the booster vaccination administration:

  • Use of any investigational or non-registered product other than the study vaccine(s) 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.
  • 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.

    • Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Boostrix-REF Group

Boostrix-US Group

Boostrix-INV Group

Arm Description

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Outcomes

Primary Outcome Measures

Number of Seroprotected Subjects Against Diphtheria and Tetanus
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Number of Seroprotected Subjects Against Diphtheria and Tetanus
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.

Secondary Outcome Measures

Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..
Number of Subjects With Any Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Full Information

First Posted
May 20, 2010
Last Updated
June 28, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01147900
Brief Title
Evaluation of Boostrix™10 Years After Previous Booster Vaccination
Official Title
Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 15, 2010 (undefined)
Primary Completion Date
May 8, 2012 (Actual)
Study Completion Date
May 8, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate study (see reference).
Detailed Description
All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acellular Pertussis, Tetanus, Diphtheria
Keywords
Immune persistence, Boostrix, dTpa booster study

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boostrix-REF Group
Arm Type
Experimental
Arm Description
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Arm Title
Boostrix-US Group
Arm Type
Experimental
Arm Description
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Arm Title
Boostrix-INV Group
Arm Type
Experimental
Arm Description
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Boostrix™
Intervention Description
Intramuscular, single dose
Intervention Type
Biological
Intervention Name(s)
Boostrix™-US formulation
Intervention Description
Intramuscular, single dose
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Description
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
At Year 8.5
Title
Concentrations for Anti-D and Anti-T Antibodies.
Description
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Time Frame
At Year 8.5
Title
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
Description
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
At Year 10
Title
Concentrations for Anti-D and Anti-T Antibodies.
Description
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time Frame
At Year 10
Title
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
Description
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame
At Year 8.5
Title
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Description
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
Time Frame
At Year 8.5
Title
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description
A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame
At Year 10
Title
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Time Frame
At Year 10
Title
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Description
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Title
Concentrations for Anti-D and Anti-T Antibodies.
Description
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Time Frame
At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Title
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Time Frame
At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Title
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Description
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Time Frame
At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Title
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
Description
A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.
Time Frame
At 1 month post Year 10 booster vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With Any Solicited Local Symptoms.
Description
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Time Frame
During the 4-day (Days 0-3) follow-up period after booster vaccination
Title
Number of Subjects With Any Solicited General Symptoms.
Description
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.
Time Frame
During the 4-day (Days 0-3) follow-up period after booster vaccination
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Description
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Time Frame
During the 31-day (Days 0-30) follow-up period after booster vaccination
Title
Number of Subjects With Any Serious Adverse Events (SAEs).
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..
Time Frame
At Year 8.5
Title
Number of Subjects With Any Serious Adverse Events (SAEs).
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
From Year 8.5 up to study end (one month post Year 10 booster vaccination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol. Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029. Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination. Healthy subjects as established by medical history and clinical examination. Female subjects of non-childbearing potential may receive the booster vaccine. Female subjects of childbearing potential may 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: Exclusion criteria to be checked at study entry: Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029. History of diphtheria, tetanus, or laboratory confirmed pertussis disease. Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. 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 (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 three days of vaccination. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Additional exclusion criteria to be checked for subjects before the booster vaccination administration: Use of any investigational or non-registered product other than the study vaccine(s) 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. 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. Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25613716
Citation
Vandermeulen C, Theeten H, Rathi N, Kuriyakose S, Han HH, Sokal E, Hoppenbrouwers K, Van Damme P. Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium. Vaccine. 2015 Jun 12;33(26):3026-34. doi: 10.1016/j.vaccine.2014.10.049. Epub 2015 Jan 19.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113055
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113055
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113055
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113055
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113055
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113055
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Evaluation of Boostrix™10 Years After Previous Booster Vaccination

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