Last updated: 11/07/2018 05:34:00
Evaluation of Boostrix™10 years after previous booster vaccination
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluation of GSK Biologicals’ Boostrix™ in healthy adults, 10 years after previous booster vaccination
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of seroprotected subjects against diphtheria and tetanus
Timeframe: At Year 8.5
Concentrations for anti-D and anti-T antibodies.
Timeframe: At Year 8.5
Number of seroprotected subjects against diphtheria and tetanus.
Timeframe: At Year 10
Concentrations for anti-D and anti-T antibodies.
Timeframe: At Year 10
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous haemagglutinin (anti-FHA) antibodies.
Timeframe: At Year 8.5
Concentrations for anti-PT, anti-PRN and anti-FHA antibodies.
Timeframe: At Year 8.5
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.
Timeframe: At Year 10
Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.
Timeframe: At Year 10
Number of seroprotected subjects against diphtheria and tetanus
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations for anti-D and anti-T antibodies.
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies.
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations for anti-PT, anti-FHA and anti-PRN antibodies.
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Number of booster responders to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens.
Timeframe: At 1 month post Year 10 booster vaccination
Secondary outcomes:
Number of subjects with any solicited local symptoms.
Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of subjects with any solicited general symptoms.
Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of subjects with any unsolicited adverse events (AEs).
Timeframe: During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of subjects with any serious adverse events (SAEs).
Timeframe: At Year 8.5
Number of subjects with any serious adverse events (SAEs).
Timeframe: From Year 8.5 up to study end (one month post Year 10 booster vaccination)
Interventions:
Enrollment:
180
Primary completion date:
2012-08-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Vandermeulen C et al. (2015) Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium. Vaccine. 33(26):3026-3034.
Medical condition
acellular pertussis, Tetanus, Diphtheria
Product
SB263855
Collaborators
Not applicable
Study date(s)
June 2010 to May 2012
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 28 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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,
- 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.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Exclusion criteria to be checked at study entry:
convulsions with or without fever, occurring within three days of vaccination.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2012-08-05
Actual study completion date
2012-08-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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