Last updated: 11/03/2018 11:21:47
Safety and immunogenicity of a booster dose of GSK Biological's Boostrix-Polio vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluation of GSK Biological’s dTpa-IPV booster vaccine in children and adolescents, 5 years after previous dTpa-IPV boosting.
Trial description: Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects with any Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) follow-up period after 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 anti-diphtheria (Anti-D) and anti-tetanus (Anti-T) toxoids
Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and anti-T antibody concentrations
Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of seroprotected subjects against Polio type 1, 2 and 3 antigens
Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-Polio 1, 2 and 3 antibody titers
Timeframe: Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of subjects with booster response to anti-PT, anti-FHA and anti-PRN
Timeframe: One month after booster vaccination (At Month 1)
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0–30) follow-up period after booster vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire booster period (Month 0 to Month 1)
Interventions:
Biological/vaccine: Boostrix-Polio
Enrollment:
415
Observational study model:
Not applicable
Primary completion date:
2008-08-07
Time perspective:
Not applicable
Clinical publications:
Knuf M et al. The repeated administration of a reduced antigen content diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (dTpa-IPV; BoostrixTM IPV) in adolescents. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
Knuf M, Baine Y, Bianco V, Boutriau D, Miller JM.Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children.Hum Vaccin Immunother. 2012 Jul;8(7):866-72.
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-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.
Medical condition
Poliomyelitis, Diphtheria, Tetanus, acellular pertussis
Product
SB711866
Collaborators
Not applicable
Study date(s)
February 2008 to July 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
9 - 13 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the booster dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
- Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressant 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 vaccination, or planned administration during 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 tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
- History of diphtheria, tetanus, pertussis, or poliomyelitis 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 immunoglobulin 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 events (AEs) 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 within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
- Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
- Acute disease at the time of enrolment.
- Pregnant or lactating female.
Trial location(s)
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Study Complete
Location
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
Status
Study Complete
Location
GSK Investigational Site
Brunsbuettel, Schleswig-Holstein, Germany, 25541
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24939
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67549
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
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
Completed
Actual primary completion date
2008-08-07
Actual study completion date
2008-08-07
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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