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AzTrials

PertussisPhase 4NCT00304265

Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

A Phase 4 study testing COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®) in people with Pertussis and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 17 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

Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine. Read more about this study

Who is it for?
Ages 10 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Pertussis, Diphtheria, Tetanus
What is being tested?
COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
17 sitesGermany
Study dates
Mar 2006to Oct 2007
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 10 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Eligible to receive REPEVAX® or COVAXIS® vaccine, in accord with German recommendations for a booster dose of acellular pertussis vaccine at 9-17 years of age.
  • Signed and dated informed consent or assent form (as applicable) that is obtained prior to the first study intervention.
  • Judged to be in good health on the basis of reported medical history and history-directed physical examination.
  • Plans to remain in the study area for the length of the trial.
  • The participant and a parent or legal guardian can read, write, and understand the documents and all are mentally competent to give assent and consent.
  • If female, not known or suspected to be pregnant at the time of enrollment into the study and is not planning pregnancy during participation in this trial.
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  • Either prior participation in study 371-03/01 (Group 1 - 6th Dose Pertussis Vaccine Group) or a documented history of 3 doses of tetanus, diphtheria and whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life (Group 2 - 5th Dose Pertussis Vaccine Group).
  • Has access to a telephone.
  • Oral temperature < 38.0ºC.

Who cannot join

  • Pregnancy or nursing a child
  • Known or suspected primary or acquired disease of the immune system (conditions suspected of having an immunologic component such as autoimmune diseases [e.g. rheumatoid arthritis or inflammatory bowel disease] will not be excluded unless they meet exclusion criterion 3 or 5).
  • Malignancy, allergy immunotherapy, or receiving immunosuppressive therapy (participants who are taking topical and inhaled steroids could be included in the study as would participants on a "short course" of oral steroids, -<7 days, as long as there are not two courses within the previous two weeks prior to vaccination).
  • Receipt of any pertussis, diphtheria or tetanus-containing vaccines within the past 3 years.
  • Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
  • Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures.
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  • Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the last 2 years.
  • Receipt of blood products or immunoglobulin within the previous 3 months.
  • Known or suspected allergy to any of the vaccines or vaccine components intended for use in the study.
  • Daily use of non-steroidal anti-inflammatory drugs.
  • Receipt of any vaccine or investigational product within the 30 days prior to enrollment, or planning to receive another vaccine within 28 days after receiving study vaccine.
  • Chemical dependency (e.g. alcoholism or intravenous drug use but not including nicotine or caffeine), based on investigator judgment.
  • Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis, respiratory problems (e.g. wheezing, shortness of breath).
  • Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
  • History of immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving diphtheria, tetanus, or pertussis vaccine.
  • Planned participation in another interventional clinical trial during the present trial period (participation in a related study to evaluate immune responses to this study's vaccination is permitted).
  • Thrombocytopenia or bleeding disorder that would pose a contraindication to an intramuscular (IM) vaccination.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Germany17 sites

  • Study site

    Bielefeld, D-33611

  • Study site

    Detmold, D-32756

  • Study site

    Donzdorf, D-73072

  • Study site

    Grafing, D-85567

  • Study site

    Heilbronn, D-74072

  • Study site

    Lauffen am Neckar, D-74348

  • Study site

    Marbach, D-71672

  • Study site

    Marktoberdorf, D-87616

  • Study site

    Munich, Lindwurmstrasse 4, D-80337

  • Study site

    Munich, D-80939

  • Study site

    Munich, D-81247

  • Study site

    Schwäbisch Hall, D-74523

  • Study site

    Schwandorf in Bayern, D-92421

  • Study site

    Schwieberdingen, D-71701

  • Study site

    Stuttgart, D-70469

  • Study site

    Süßen, D-73079

  • Study site

    Veitshöchheim, D-97209

Other trials in Germany

About this study

Official title: Reactogenicity of Acellular Pertussis Vaccine Booster in Adolescents Who Have Received 5 Prior Doses of BIKEN Acellular Pertussis Vaccine in Combination With Diphtheria and Tetanus Toxoids (TRIPEDIA®) or Who Have Received Primary Vaccination With 3 Doses of Whole-Cell Pertussis Vaccine, Plus at Least 1 Pertussis Booster Vaccination

Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine.

To describe and characterize adverse events occurring after vaccination with REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine among two groups: Group 1 - adolescents 10-14 years of age who participated in study 371-03/01 (and thus received a 5th dose of TRIPEDIA® vaccine) and Group 2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life.

Being tested
COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
Keywords
Pertussis,, Diphtheria,, Tetanus,, Poliomyelitis
Medical subject headings
Whooping Cough, Diphtheria, Tetanus, Poliomyelitis

What participants receive

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

  • COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)Biological

    Also called REPEVAX®, COVAXIS™, IPV Merieux™

    0.5 mL, Intramuscular

Study groups in NCT00304265
Study groupRoleWhat they receive
6th Dose Pertussis Vaccine GroupExperimentalParticipants received 6th dose of pertussis vaccine
Receives: Biological: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
5th Dose Pertussis Vaccine GroupExperimentalParticipants received 5th dose of pertussis vaccine
Receives: Biological: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)

What is being measured

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

  1. Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine

    Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.

    Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

    Measured: Days 0 to 14 Post-vaccination

Timeline

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

  1. First posted17 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionOct 2006
  4. Study completionOct 2007

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00304265
Sponsor's protocol ID
TRI05
Status last verified
Apr 2016
First submitted
16 Mar 2006
Last updated
14 Apr 2016
Data monitoring committee
Yes

Publications

  • Liese JG, Rieber N, Malzer T, Ocak M, Johnson DR, Decker MD; Munich Vaccine Study Group. Reactogenicity of tetanus, diphtheria, 5-component acellular pertussis vaccine administered as a sixth consecutive acellular pertussis vaccine dose to adolescents. Pediatr Infect Dis J. 2010 Dec;29(12):1067-71. doi: 10.1097/INF.0b013e3181ea5866.

    PubMed 20616762

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®) in people with Pertussis and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 17 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 9 inclusion and 17 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 7 Apr 2011). 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 Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine (time frame: Days 0 to 14 Post-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 NCT00304265, which also lists 1 linked publication.

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 14 Apr 2016.

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