Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00304265

Pertussis Diphtheria Tetanus +1 more

COMPLETED PHASE4

Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

NCT01546909

Diphtheria Tetanus Poliomyelitis

COMPLETED PHASE4

Safety of REPEVAX® Given One Month After REVAXIS®

NCT00400309

Healthy Adult

COMPLETED PHASE3

Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine

NCT01262924

Diphteria, Tetanus and Pertussis

COMPLETED PHASE3

REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

NCT00447525

Diphtheria Tetanus Poliomyelitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

REPEVAX

Group Type EXPERIMENTAL

REPEVAX

Intervention Type BIOLOGICAL

1 dose of 0.5 mL at Day 0

Monovalent tetanus vaccine

Group Type ACTIVE_COMPARATOR

Monovalent Tetanus vaccine

Intervention Type BIOLOGICAL

1 dose of 0.5 mL at Day 0

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

REPEVAX

1 dose of 0.5 mL at Day 0

Intervention Type BIOLOGICAL

Monovalent Tetanus vaccine

1 dose of 0.5 mL at Day 0

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy adults aged ≥18 years
* Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence)
* Subject with vaccination history of a primary immunisation with a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the local vaccination calendar
* Negative urine pregnancy test for female subjects of child-bearing potential. A female subject who is of reproductive potential must agree to remain abstinent or use (or have her partner use) acceptable methods of birth control during the study period
* Subject having signed the informed consent form prior to participation in the study

Exclusion Criteria

* Acute severe illness or fever (\>=38.0°C) within the last 3 days
* Hypersensitivity or known allergy to one of the components of one of the study vaccines (including formaldehyde, streptomycin, neomycin, polymyxin B, or glutaraldehyde)
* Anaphylactic or other allergic reactions to a previous dose of a vaccine containing diphtheria or tetanus toxoids or poliomyelitis viruses or pertussis (acellular or whole cell)
* Guillain Barré syndrome or neuropathy of brachial plexus following a previous vaccination with a tetanus toxoid containing vaccine
* Known encephalopathy after receipt of a pertussis vaccine or neurological disorders after an injection with the same antigens
* Progressive or unstable neurological disorder, uncontrolled seizures or progressive encephalopathy not stabilized
* Known malignant disease, note:

* subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs),
* subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and
* subjects with a history of other malignancies who have been disease-free for at least 5 years will be eligible for enrollment
* Immunosuppressive therapy:

* High dose (≥ 20 mg/day prednisone equivalent) systemic (≥ 14 days) corticosteroid treatment daily or on alternate day within the last 28 days (inhaled corticosteroids allowed)
* Chemotherapeutic agents used to treat cancer or other conditions
* Treatments associated with organ or bone marrow transplantation
* Immune dysfunction caused by a medical condition, or any other cause (e.g., congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma or generalized malignancy)
* Known severe thrombocytopenia or coagulation disorder contraindicating an intramuscular injection
* Administration of blood products including immunoglobulins within the last 90 days or planned before Visit 3
* Recent administration of a live vaccine (≤28 days) or an inactivated vaccine (≤14 days) or vaccination planned before Visit 3
* For female subjects, pregnancy (positive pregnancy test before first blood sample) or breast-feeding through Visit 3
* Planned participation in another clinical study during the present study period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes