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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00548171




Registration number
NCT00548171
Ethics application status
Date submitted
22/10/2007
Date registered
23/10/2007
Date last updated
15/01/2019

Titles & IDs
Public title
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
Scientific title
Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 10 Years After Previous dTpa Boosting.
Secondary ID [1] 0 0
110804
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acellular Pertussis 0 0
Tetanus 0 0
Diphtheria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Boostrix™

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.

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.


Other interventions: Boostrix™
Intramuscular injection, 1 dose

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
One month after the booster vaccination [PI(M1)]
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Prior (PRE) to booster vaccination
Secondary outcome [4] 0 0
Anti-DT and Anti-TT Antibody Concentrations - Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Timepoint [4] 0 0
Prior to the booster vaccination
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Prior the booster vaccination
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Prior the booster vaccination
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Prior the booster vaccination
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
Prior the booster vaccination
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Prior to the booster vaccination
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Prior to the booster vaccination
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
One month after the booster vaccination
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
One month after the booster vaccination
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Secondary outcome [14] 0 0
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).
Timepoint [14] 0 0
Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Secondary outcome [15] 0 0
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).
Timepoint [15] 0 0
One month after the booster vaccination
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
During the 4-day (Day 0-3) follow-up period after booster vaccination
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
During the 4-day (Day 0-3) follow-up period after booster vaccination
Secondary outcome [18] 0 0
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.
Timepoint [18] 0 0
During the 31-day (Day 0-30) follow-up period after booster vaccination
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
Following the booster vaccination

Eligibility
Key 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.
Minimum age
28 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00548171
Trial related presentations / publications
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.
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.
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.
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. Buenos Aires, Argentina, 19-22 November 2009.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications