DiphtheriaPhase 3NCT01040052
A Study to Assess the Safety of Adacel® Vaccine
A Phase 3 study testing Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- Dec 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial
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.
Read the detailed description
Participants will receive a single dose of Adacel® vaccine and will be followed closely during 30 minutes post-vaccination period; a home visit will be made daily during 7 days following vaccination in order to monitor safety.
An additional visit will be conducted 30 days post-vaccination to collect safety information.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Being tested
- Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
- Keywords
- Diphtheria, Tetanus, Pertussis, Adacel®
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)Biological
Also called Adacel®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Days 0-7 Post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040052
- Sponsor's protocol ID
- TD532
- Other IDs
- U1111-1111-6093
- Status last verified
- Apr 2016
- First submitted
- 21 Dec 2009
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bridging Study to Assess the Safety of the Vaccine Adacel® in a Clinical Trial
- ClinicalTrials.gov ID
- NCT01040052
- Acronym / sponsor ID
- TD532
- Conditions
- Diphtheria, Tetanus, Pertussis
- Keywords
- Diphtheria, Tetanus, Pertussis, Adacel®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Posted 29 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will receive a single dose of Adacel® vaccine and will be followed closely during 30 minutes post-vaccination period; a home visit will be made daily during 7 days following vaccination in order to monitor safety.
An additional visit will be conducted 30 days post-vaccination to collect safety information.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)Also: Adacel®0.5 mL, Intramuscular | Biological | Study Group |
Primary outcome
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Time frame: Days 0-7 Post-vaccination
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine (time frame: Days 0-7 Post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.