Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00548171
Ethics application status
Date submitted
22/10/2007
Date registered
23/10/2007

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
Diphtheria-Tetanus-acellular Pertussis Vaccines 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: Boostrix™
Intramuscular injection, 1 dose
Intervention code [1] 0 0
Treatment: Other
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)
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
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
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
Timepoint [3] 0 0
Prior (PRE) to booster vaccination
Secondary outcome [4] 0 0
Anti-DT and Anti-TT Antibody Concentrations
Timepoint [4] 0 0
Prior to the booster vaccination
Secondary outcome [5] 0 0
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Timepoint [5] 0 0
Prior the booster vaccination
Secondary outcome [6] 0 0
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
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
Timepoint [7] 0 0
Prior the booster vaccination
Secondary outcome [8] 0 0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Timepoint [8] 0 0
Prior the booster vaccination
Secondary outcome [9] 0 0
Number of Seronegative Subjects for Anti-DT Antibodies - 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.
Timepoint [10] 0 0
Prior to the booster vaccination
Secondary outcome [11] 0 0
Number of Seronegative Subjects for Anti-DT Antibodies - 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
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
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
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
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
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
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)
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)
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
Sex
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
5/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2008
Sample size
Target
Accrual to date
Final
203
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD is available via the Clinical Study Data Request site (click on the link provided below)

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Posting.aspx?ID=148


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00548171