NCT01040052

Brief Summary

The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration. Primary objective: To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 29, 2011

Completed
Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

December 21, 2009

Results QC Date

March 1, 2011

Last Update Submit

April 12, 2016

Conditions

DiphtheriaTetanusPertussis

Keywords

DiphtheriaTetanusPertussisAdacel®

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine

    Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).

    Days 0-7 Post-vaccination

Study Arms (1)

Study Group

EXPERIMENTAL
Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)

Interventions

Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Adacel®
Study Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female (not pregnant) from 18-45 years of age.
  • Healthy, with no current illnesses.
  • Have not been immunized against diphtheria, pertussis and tetanus in the past 5 years.
  • Women of childbearing age will agree to use birth control during the study.
  • In good health, as verified by the following criteria: Heart rate, blood pressure, temperature and health history.
  • Able to understand and comply with requirements of the study.
  • A voluntary consent form is required before participating in the study.

You may not qualify if:

  • History of allergy to any ingredient in the vaccine.
  • A positive pregnancy test (for women of childbearing age) or women who are breastfeeding.
  • Compromised immune system due to treatment of a progressive disease.
  • Currently on oral or injected steroids, inhaled high-dosage steroids or other immunodeficiency or toxic drugs.
  • History of taking Immunoglobulin or other products during the 3 months prior to participating in the study.
  • Received other vaccines during the 4 months prior to participating in the study.
  • Has an acute or chronic condition that affects safety (including but not limited to: chronic liver disease, some kidney pathologies, progressive or unstabilized nerve disorders, diabetes and organ transplants).
  • Experienced a severe adverse event after receiving ADACEL® vaccine.
  • History of acute illness with temperatures over 37.5ºC during the week before receiving the vaccine.
  • Human immunodeficiency virus (HIV) infection.
  • History of alcohol or drug addiction during the past 5 years.
  • Plans to travel outside of the study area between shots and visits.
  • History of Guillain-Barré syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Việt Trì, Phu Tho, Vietnam

Location

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusWhooping Cough

Interventions

adacelTetanus Toxoid

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

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

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 25, 2009

Study Start

December 1, 2009

Primary Completion

February 1, 2010

Study Completion

April 1, 2010

Last Updated

May 16, 2016

Results First Posted

March 29, 2011

Record last verified: 2016-04

Locations

VN(1)