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PoliomyelitisPhase 4NCT00635128

Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

A Phase 4 study testing Boostrix-Polio in people with Poliomyelitis and Diphtheria, run by GlaxoSmithKline at 38 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 9 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Poliomyelitis, Diphtheria, Tetanus
What is being tested?
Boostrix-Polio
Could I receive a placebo?
No, everyone receives an active treatment
How many people
415 participants
Where
38 sitesGermany
Study dates
1 Feb 2008to 8 Jul 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 locations and contacts

38 sites in 1 country.

38 sites in 1 country

Germany38 sites

  • GSK Investigational Site

    Bad Kreuznach, Rhineland-Palatinate, 55543

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Berlin, 13355

  • GSK Investigational Site

    Berlin, 13507

  • GSK Investigational Site

    Brunsbüttel, Schleswig-Holstein, 25541

  • GSK Investigational Site

    Cham, Bavaria, 93413

  • GSK Investigational Site

    Dresden, Saxony, 01169

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Erkrath, North Rhine-Westphalia, 40699

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Ettenheim, Baden-Wurttemberg, 77955

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24937

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24939

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24943

  • GSK Investigational Site

    Frankenthal, Rhineland-Palatinate, 67227

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Gütersloh, North Rhine-Westphalia, 33332

  • GSK Investigational Site

    Heiligenhaus, North Rhine-Westphalia, 42579

  • GSK Investigational Site

    Kaufering, Bavaria, 86916

  • GSK Investigational Site

    Kehl, Baden-Wurttemberg, 77694

  • GSK Investigational Site

    Kleve-Materborn, North Rhine-Westphalia, 47533

  • GSK Investigational Site

    Koenigstein, Hesse, 61462

  • GSK Investigational Site

    Krefeld, North Rhine-Westphalia, 47798

  • GSK Investigational Site

    Landshut, Bavaria, 84032

  • GSK Investigational Site

    Löhne, North Rhine-Westphalia, 32584

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Munich, Bavaria, 80939

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48159

  • GSK Investigational Site

    Oberkirch, Baden-Wurttemberg, 77704

  • GSK Investigational Site

    Offenburg, Baden-Wurttemberg, 77654

  • GSK Investigational Site

    Olching, Bavaria, 82140

  • GSK Investigational Site

    Salzgitter, Lower Saxony, 38226

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54294

  • GSK Investigational Site

    Weilheim, Bavaria, 82362

  • GSK Investigational Site

    Willich, North Rhine-Westphalia, 47877

  • GSK Investigational Site

    Wolfenbüttel, Lower Saxony, 38302

  • GSK Investigational Site

    Worms, Rhineland-Palatinate, 67547

  • GSK Investigational Site

    Worms, Rhineland-Palatinate, 67549

Other trials in Germany

About this study

Official title: Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.

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.

Being tested
Boostrix-Polio
Keywords
Diphtheria, vaccine, DTP, Poliomyelitis, Pertussis, Booster, Tetanus
Medical subject headings
Poliomyelitis, Diphtheria, Tetanus, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boostrix-PolioBiological

    A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

Study groups in NCT00635128
Study groupRoleWhat they receive
BOOSTRIX-POLIO GROUPExperimentalHealthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Boostrix-Polio
BOOSTRIX + IPV MÉRIEUX GROUPExperimentalHealthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Boostrix-Polio

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Any Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

    Measured: During the 4-day (Days 0-3) follow-up period after booster vaccination

Secondary outcomes (11)

  1. Number of Subjects With Any Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

    Measured: During the 4-day (Days 0-3) follow-up period after booster vaccination

  2. Number of Subjects With Any Solicited General Symptoms

    Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.

    Measured: During the 4-day (Days 0-3) follow-up period after booster vaccination

  3. Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids

    Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.

    Measured: Prior to (Month 0) and one month after (Month 1) booster vaccination

  4. Anti-D and Anti-T Antibody Concentrations

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

    Measured: Prior to (Month 0) and one month after (Month 1) booster vaccination

  5. Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)

    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).

    Measured: Prior to (Month 0) and one month after (Month 1) booster vaccination

  6. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

    Measured: Prior to (Month 0) and one month after (Month 1) booster vaccination

  7. Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens

    A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.

    Measured: Prior to (Month 0) and one month after (Month 1) booster vaccination

  8. Anti-Polio 1, 2 and 3 Antibody Titers

    Antibody titers were presented as geometric mean titers (GMTs).

    Measured: Prior to (Month 0) and one month after (Month 1) booster vaccination

  9. Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN

    Booster vaccine 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).

    Measured: One month after booster vaccination (At Month 1)

  10. Number of Subjects With Unsolicited Adverse Events (AEs)

    AEs results are presented for all subjects. 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.

    Measured: During the 31-day (Days 0-30) follow-up period after booster vaccination

  11. Number of Subjects With Serious Adverse Events (SAEs)

    Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Measured: During the entire booster period (Month 0 to Month 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2008 (estimated)
  2. Study start1 Feb 2008
  3. Primary completion8 Jul 2008
  4. Study completion8 Jul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00635128
Sponsor's protocol ID
110947
Status last verified
Apr 2017
First submitted
6 Mar 2008
Last updated
6 Jun 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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. doi: 10.4161/hv.20229. Epub 2012 Apr 9.

    PubMed 22485049

  • 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.

  • Knuf M, Vetter V, Celzo F, Ramakrishnan G, Van Der Meeren O, Jacquet JM. Repeated administration of a reduced-antigen-content diphtheria-tetanus-acellular pertussis and poliomyelitis vaccine (dTpa-IPV; Boostrix IPV). Hum Vaccin. 2010 Jul;6(7):554-61. doi: 10.4161/hv.6.7.11760.

    PubMed 20448468

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Boostrix-Polio in people with Poliomyelitis and Diphtheria, run by GlaxoSmithKline at 38 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Any Grade 3 Solicited Local Symptoms (time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00635128, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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