Back to resultsImmunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
Primary Purpose
Acellular Pertussis, Tetanus, Diphtheria
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Boostrix™
Sponsored by
About this trial
This is an interventional prevention trial for Acellular Pertussis
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Boostrix I Group
Boostrix II Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values
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
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
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
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
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
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
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
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.
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.
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
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
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
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
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
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
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
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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00548171
Brief Title
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
Official Title
Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 10 Years After Previous dTpa Boosting.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2007 (Actual)
Primary Completion Date
April 30, 2008 (Actual)
Study Completion Date
April 30, 2008 (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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acellular Pertussis, Tetanus, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Boostrix I Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Boostrix II Group
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Boostrix™
Intervention Description
Intramuscular injection, 1 dose
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
One month after the booster vaccination [PI(M1)]
Secondary Outcome Measure Information:
Title
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values
Description
Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL.
Time Frame
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Title
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Description
Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Title
Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values
Description
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.
Time Frame
Prior (PRE) to booster vaccination
Title
Anti-DT and Anti-TT Antibody Concentrations
Description
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame
Prior to the booster vaccination
Title
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Description
Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Time Frame
Prior the booster vaccination
Title
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Description
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.
Time Frame
Prior the booster vaccination
Title
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Description
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.
Time Frame
Prior the booster vaccination
Title
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL)
Time Frame
Prior the booster vaccination
Title
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA.
Description
Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Time Frame
Prior to the booster vaccination
Title
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test.
Description
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.
Time Frame
Prior to the booster vaccination
Title
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Description
Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Time Frame
One month after the booster vaccination
Title
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Description
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.
Time Frame
One month after the booster vaccination
Title
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Description
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.
Time Frame
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Title
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Time Frame
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Title
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Description
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).
Time Frame
One month after the booster vaccination
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
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.
Time Frame
During the 4-day (Day 0-3) follow-up period after booster vaccination
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
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.
Time Frame
During the 4-day (Day 0-3) follow-up period after booster vaccination
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 31-day (Day 0-30) follow-up period after booster vaccination
Title
Number of Subjects With 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 or result in disability/incapacity.
For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Time Frame
Following the booster vaccination
10. Eligibility
Sex
All
Minimum 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 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.
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
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=148
Citations:
PubMed Identifier
20974302
Citation
Booy R, Van der Meeren O, Ng SP, Celzo F, Ramakrishnan G, Jacquet JM. A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix) is immunogenic and well tolerated in adults. Vaccine. 2010 Dec 10;29(1):45-50. doi: 10.1016/j.vaccine.2010.10.025. Epub 2010 Oct 23.
Results Reference
background
Citation
Booy R et al. The decennial administration of a reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (dTpa; BoostrixTM) in adults. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
Results Reference
background
Citation
Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
Results Reference
background
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110804
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
110804
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110804
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
110804
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
110804
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110804
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
110804
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
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