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

March 24, 2015 updated by: Sanofi Pasteur, a Sanofi Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1
Participants 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.
Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV
0.5 mL, Intramuscular
Other Names:
  • TdcP-IPV
Biological: Hepatitis B vaccine
0.5 ml, Intramuscular
Other Names:
  • Recombivax HB®
Active Comparator: Study Group 2
Participants 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.
Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV
0.5 mL, Intramuscular
Other Names:
  • TdcP-IPV
Biological: Hepatitis B vaccine
0.5 ml, Intramuscular
Other Names:
  • Recombivax HB®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination
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
Time Frame: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination
Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay
Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial
Time Frame: Day 0 up to day 30 following each vaccination
Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches.
Day 0 up to day 30 following each vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination
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.
Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Investigators

  • Study Director: Medical Director, Sanofi Pasteur Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

May 1, 2000

Study Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD9809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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