NCT00347958

Brief Summary

Objectives: To provide safety data on revaccination with ADACEL® vaccine. To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

Typical duration for phase_4

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 22, 2010

Completed
Last Updated

December 4, 2013

Status Verified

November 1, 2013

Enrollment Period

1.5 years

First QC Date

July 3, 2006

Results QC Date

May 14, 2010

Last Update Submit

November 11, 2013

Conditions

TetanusDiphtheriaPertussis

Keywords

Tetanus,Diphtheria,Pertussis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination

    Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.

    0-14 days post-vaccination

Other Outcomes (3)

  • Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.

    Day 28 post-vaccination

  • Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.

    Day 28 post-vaccination

  • Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®

    Day 28 post-vaccination

Study Arms (1)

Adacel vaccine group

EXPERIMENTAL

Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.

Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine

Interventions

Tetanus-diphtheria-acellular pertussis (Tdap) vaccineBIOLOGICAL

0.5mL, Intramuscular (IM)

Also known as: Adacel®
Adacel vaccine group

Eligibility Criteria

Age15 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.
  • At least 15 but no greater than 69 years of age at the time of vaccination in this trial.
  • Signed Institutional Review Board (IRB)-approved informed assent / consent form.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • For a woman, inability to become pregnant or negative serum/urine pregnancy test.

You may not qualify if:

  • Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
  • Serious chronic disease (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:
  • interfere with the ability to participate fully in the study; or
  • interfere with evaluation of the vaccine.
  • Known or suspected impairment of immunologic function.
  • History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
  • Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment
  • Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Suspected or known hypersensitivity to any of the vaccine components or to latex.
  • Unable to attend the scheduled visits or to comply with the study procedures.
  • In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.
  • Nursing mother.
  • Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Jonesboro, Arkansas, 72401, United States

Location

Unknown Facility

Bossier City, Louisiana, 71111, United States

Location

Unknown Facility

University Heights, Ohio, 44118, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15241, United States

Location

Unknown Facility

Coquitlam, British Columbia, V3C 4J2, Canada

Location

Unknown Facility

Surrey, British Columbia, V3R-8P8, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3K-6R8, Canada

Location

Unknown Facility

Beauport, Quebec, G1E 7G9, Canada

Location

Unknown Facility

Montreal, Quebec, H3H LP3, Canada

Location

Related Links

MeSH Terms

Conditions

TetanusDiphtheriaWhooping Cough

Interventions

Vaccinesadacel

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsCorynebacterium InfectionsActinomycetales InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur Inc.
RegistryContactUs@sanofipasteur.com

Study Officials

  • Clinical Trials

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

August 1, 2006

Primary Completion

February 1, 2008

Study Completion

October 1, 2008

Last Updated

December 4, 2013

Results First Posted

July 22, 2010

Record last verified: 2013-11

Locations

US(4)CA(6)