Last updated: 11/07/2018 10:34:54
Immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Boostrix™ vaccine in previously boosted young adults
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluation of immunogenicity and safety of GSK Biologicals' Tdap booster vaccine (Boostrix™) in young adults, administered 10 years after previous Tdap boosting
Trial description: The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00109330).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T).
Timeframe: At Month 1
Antibody concentrations against pertussis toxoid (anti-PT), against filamentous hemagglutinin (anti-FHA) and against pertactin (anti-PRN).
Timeframe: At Month 1
Secondary outcomes:
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T).
Timeframe: At Month 0
Number of subjects with anti-D and anti-T concentrations above the cut-off.
Timeframe: At Month 0 and Month 1
Anti-D and anti-T antibody concentrations.
Timeframe: At Month 0 and Month 1
Antibody concentrations against pertussis toxoid (anti-PT), against filamentous hemagglutinin (anti-FHA) and against pertactin (anti-PRN).
Timeframe: At Month 0
Number of subjects with a booster response to anti-D and anti-T.
Timeframe: At Month 1
Number of subjects with a booster response to anti-PT, anti-FHA and anti-PRN.
Timeframe: At Month 1.
Number of subjects with solicited local symptoms.
Timeframe: During the 4 days (Day 0 – 3) follow-up period after vaccination.
Number of subjects with solicited general symptoms.
Timeframe: During the 4 days (Day 0 – 3) follow-up period after vaccination.
Number of subjects with unsolicited adverse events (AEs).
Timeframe: During the 31 days (Day 0 – 30) after vaccination.
Number of subjects with serious adverse events (SAEs).
Timeframe: From Day 0 to 31 days post-vaccination.
Interventions:
Enrollment:
165
Primary completion date:
2014-02-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kovac M et al. (2018) Immunogenicity and safety of a second booster dose of an acellular pertussis vaccine combined with reduced antigen content diphtheria-tetanus toxoids 10 years after a first booster in adolescence: An open, phase III, non-randomized, multi-center study. Hum Vaccin Immunother. 14(8):1977-1986. doi: 10.1080/21645515.2018.1460292.
Medical condition
Tetanus, acellular pertussis, Diphtheria
Product
SB776423
Collaborators
Not applicable
Study date(s)
January 2013 to April 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
19 - 30 years
Accepts healthy volunteers
Yes
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- Subjects who have received a dose of Tdap or Td vaccines 10 years (+/-300 days) back, in study NCT00109330.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . For corticosteroids, this will mean prednisone (≥ 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who have received a dose of Tdap or Td vaccines 10 years (+/-300 days) back, in study NCT00109330.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the vaccine dose.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Exclusion criteria:
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . For corticosteroids, this will mean prednisone (≥ 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 31 days after the dose of vaccine, with the exception of Influenza vaccine which is allowed throughout the 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 vaccine/product (pharmaceutical product or device).
- Previous vaccination against diphtheria, tetanus or pertussis since the last dose received in the Study NCT00109330.
- History of diphtheria, tetanus or pertussis diseases following the receipt of booster dose in the Study NCT00109330.
- Severe allergic reaction (e.g. anaphylaxis) after previous administration of any tetanus toxoid, diphtheria toxoid, or pertussis-antigen containing vaccines, or any component of Boostrix.
- Hypersensitivity to latex.
- Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of unknown etiology occurring within 7 days following previous vaccination with pertussis-containing vaccine.
- History of any neurological disorders or seizures.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 99.5°F for oral, axillary or tympanic route, or ≥ 100.4°F for rectal route. The preferred route for recording temperature in this study will be oral.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions up to 1 month post-vaccination.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Trial location(s)
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Showing 1 - 6 of 20 Results
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
2014-02-04
Actual study completion date
2014-02-04
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.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website