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AzTrials

PertussisPhase 2NCT02040636

Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

A Phase 2 study testing Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV and Hepatitis B vaccine in people with Pertussis and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in Canada.

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

Primary objective: To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated… Read more about this study

Who is it for?
Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Pertussis, Tetanus, Diphtheria
What is being tested?
Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV and Hepatitis B vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
277 participants
Where
1 siteCanada
Study dates
Jan 1999to May 2000
Phase
Phase 2
Are there results?
None posted in the registry

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 11 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age 11 years and < 14 years of age.
  • Signed, witnessed and dated informed consent that is obtained prior to the first study intervention.
  • Judged to be in good health on the basis of reported medical history.
  • Plans to remain in the study area for the length of the trial.
  • All minors have a parent or legal guardian who can read, write and understand English or French.
  • Pregnancy test to be performed on all female participants at the time of enrollment into the study (prior to day of first immunization visit).

Who cannot join

  • Pregnancy.
  • Known or suspected primary disease of the immune system [conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5].
  • Malignancy or is receiving immunosuppressive therapy (e.g., daily systemic prednisone ≥ 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as could participants on a "short course" of oral steroids, 5-7 days, as long as there are not two courses within the previous two week period).
  • Prior receipt of any pertussis, diphtheria, tetanus or polio containing vaccines, including Hepatitis B vaccine, within the past 5 years.
  • Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction.
  • Known impairment of neurologic function or seizure disorder of any etiology.
Show all 11Show fewer
  • 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 intended for use in the study or any of the vaccine components including neomycin, streptomycin and polymyxin B.
  • Receipt of any vaccine within 2 weeks of receiving a study vaccine.
  • Daily use of non-steroidal anti-inflammatory drugs.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Study site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

About this study

Official title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) Compared to Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) and Hepatitis B Vaccine Given Concurrently In Adolescents 11-14 Years of Age

Primary objective:

  • To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age.

Secondary objective:

  • To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at 11-14 years of age results in detectable immunologic interactions between components of the two vaccines.
Read the detailed description

Participants will be randomized into one of 2 groups to receive either a dose of the TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group 1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2).

All participants will be followed up for immunogenicity and safety

Being tested
Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV, Hepatitis B vaccine
Keywords
Pertussis, Tetanus, Diphtheria, Poliomyelitis, Hepatitis B, Acellular Pertussis Vaccines
Medical subject headings
Whooping Cough, Tetanus, Diphtheria, Poliomyelitis, Hepatitis B

What participants receive

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

  • Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPVBiological

    Also called TdcP-IPV

    0.5 mL, Intramuscular

  • Hepatitis B vaccineBiological

    Also called Recombivax HB®

    0.5 ml, Intramuscular

Study groups in NCT02040636
Study groupRoleWhat they receive
Study Group 1ExperimentalParticipants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) at month 0, Hepatitis B at months 1, 2 and 7.
Receives: Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV; Biological: Hepatitis B vaccine
Study Group 2Active comparatorParticipants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) + Hepatitis B at month 0, Hepatitis B at months 1 and 6.
Receives: Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV; Biological: Hepatitis B vaccine

What is being measured

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

  1. Seroprotection against diphtheria and tetanus antigens after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis (Tdcp-IPV) or concurrent Tdcp-IPV and Hepatitis B vaccine

    Seroprotection defined as: Diphtheria levels ≥ 0.01 IU/mL and ≥ 0.1 IU/mL; Tetanus levels ≥ 0.01 EU/mL and ≥ 0.1 EU/mL.

    Measured: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination

  2. Geometric Mean Titers for Diphtheria and Tetanus after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine & Inactivated Poliomyelitis Vaccine (Tdcp-IPV) or concurrent Tdcp IPV and Hepatitis B vaccine

    Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay

    Measured: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination

  3. Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial

    Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches.

    Measured: Day 0 up to day 30 following each vaccination

Secondary outcomes (1)

  1. Geometric Mean Titers for Pertussis antibodies after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP IPV) or concurrent Tdcp IPV and Hepatitis B vaccine

    Anti pertussis toxoid, anti filamentous hemagglutinin, anti fimbriae 2 + 3 and anti Pertactin antibodies were assayed by enzyme linked immunoassay; Polio types 1, 2, and 3 were assayed using neutralizing antibodies to poliovirus types1, 2 and 3.

    Measured: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years 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 posted20 Jan 2014 (estimated)
  2. Study startJan 1999
  3. Primary completionMay 2000
  4. Study completionMay 2000

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02040636
Sponsor's protocol ID
TD9809
Status last verified
Mar 2015
First submitted
16 Jan 2014
Last updated
25 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Embree J, Law B, Voloshen T, Tomovici A. Immunogenicity, safety, and antibody persistence at 3, 5, and 10 years postvaccination in adolescents randomized to booster immunization with a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliomyelitis vaccine administered with a hepatitis B virus vaccine concurrently or 1 month apart. Clin Vaccine Immunol. 2015 Mar;22(3):282-90. doi: 10.1128/CVI.00682-14. Epub 2014 Dec 24.

    PubMed 25540274

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV and Hepatitis B vaccine in people with Pertussis and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in Canada.

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 6 inclusion and 11 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Seroprotection against diphtheria and tetanus antigens after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis (Tdcp-IPV) or concurrent Tdcp-IPV and Hepatitis B vaccine (time frame: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination). The study lists 3 primary outcomes in all. 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 NCT02040636, 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 25 Mar 2015.

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