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

NCT00928785 | Completed Phase 3

• 1 other identifier: RPV02C
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Healthy

Keywords

Tetanus Vaccine; Tdap-IPV vaccine

Outcome Measures

Primary Outcomes (1)

• Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)

  10 days

Secondary Outcomes (4)

• Geometric Mean Titre (GMT) for tetanus antibodies in both groups

  Day 0, Day 1 and Day 28

• The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)

  Day 28

• Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events

  D0 to Day 7

• Percentage of subjects with serious adverse events

  D0 to Day 28

Study Arms (2)

REPEVAX

EXPERIMENTAL

Biological: REPEVAX

Monovalent tetanus vaccine

ACTIVE COMPARATOR

Biological: Monovalent Tetanus vaccine

Interventions

REPEVAX BIOLOGICAL

1 dose of 0.5 mL at Day 0

REPEVAX

Monovalent Tetanus vaccine BIOLOGICAL

1 dose of 0.5 mL at Day 0

Monovalent tetanus vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (9)

Hôpital Gabriel Montpied - CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpital St Eloi

Montpellier, 34295, France

Location

Groupe Hospitalier Cochin - Saint-Vincent de Paul

Paris, 75014, France

Location

Hôpital Bichat Claude Bernard

Paris, 75018, France

Location

Unknown Facility

Heilbronn, 74072, Germany

Location

Unknown Facility

Künzig, 94550, Germany

Location

Unknown Facility

Nettersheim, 53947, Germany

Location

Unknown Facility

Offenbach, 63071, Germany

Location

Unknown Facility

Reichenbach/Vogtland, 8468, Germany

Location

Related Publications (1)

• Laurichesse H, Zimmermann U, Galtier F, Launay O, Duval X, Richard P, Sadorge C, Soubeyrand B. Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(R)) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries. Hum Vaccin Immunother. 2012 Dec 1;8(12):1875-81. doi: 10.4161/hv.22083. Epub 2012 Oct 2.

  PMID: 23032160 DERIVED

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Medical Director

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

DE (5); FR (4)