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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2000-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pertussis Tetanus Diphtheria Poliomyelitis Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Hepatitis B vaccine

Intervention Type BIOLOGICAL

0.5 ml, Intramuscular

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.

Group Type ACTIVE_COMPARATOR

Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Hepatitis B vaccine

Intervention Type BIOLOGICAL

0.5 ml, Intramuscular

Interventions

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Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Hepatitis B vaccine

0.5 ml, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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TdcP-IPV Recombivax HB®

Eligibility Criteria

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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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes