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TetanusPhase 4NCT01311557

Study of Adacel® Vaccine Administered to Persons 10 Years of Age

A Phase 4 study testing Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed in people with Tetanus and Diphtheria, run by Sanofi at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age. Read more about this study

Who is it for?
Ages 10 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Tetanus, Diphtheria, Pertussis
What is being tested?
Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,302 participants
Where
34 sitesUnited States
Study dates
Mar 2011to Jan 2012
Phase
Phase 4
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 10 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age is > 10 to < 12 years of age at the time of vaccination.
  • Assent form has been signed and dated by the subject, and informed consent has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
  • Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
  • For a female of childbearing potential, abstinence or use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
  • Documented vaccination history of receiving 5 previous doses of DTaP (combination diphtheria, tetanus, and acellular pertussis) vaccine (consisting of 3 infant doses in the first year of life, a 4th dose in the 2nd year of life, and a 5th dose at 4 through 6 years of age).

Who cannot join

  • 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, acute, or chronic disease that is unstable or that, in the opinion of the Investigator, might: (i) interfere with the ability to participate fully in the study; or (ii) interfere with evaluation of the vaccine.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Prior receipt of pertussis, diphtheria, or tetanus containing vaccines within the past 5 years.
  • A personal history of physician-diagnosed or laboratory confirmed pertussis disease within the last 2 years.
  • A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.
Show all 16Show fewer
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of the immune response.
  • History of allergy to egg proteins, latex, or any constituents of the vaccine.
  • Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
  • Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine.
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study.
  • Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the parent/guardian.
  • Laboratory-confirmed thrombocytopenia, bleeding disorders, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, at the discretion of the Investigator.
  • Known pregnancy, or a positive urine or serum pregnancy test.
  • Prior personal history of Guillain-Barré syndrome.
  • Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Study site

    Austin, Texas, 78705

  • Study site

    Bardstown, Kentucky, 40040

  • Study site

    Barnwell, South Carolina, 29812

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Cleveland, Ohio, 44121

  • Study site

    Crestview Hills, Kentucky, 41017

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Haughton, Louisiana, 71037

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Longmont, Colorado, 80501

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Marietta, Georgia, 30062

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami Beach, Florida, 33141

  • Study site

    Midlothian, Virginia, 23113

  • Study site

    Norwich, Connecticut, 06360

  • Study site

    Orem, Utah, 84057

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Plymouth, Minnesota, 55441

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Rochester, New York, 14609

  • Study site

    Sacramento, California, 95816

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    San Antonio, Texas, 78205

  • Study site

    South Jordan, Utah, 84095

  • Study site

    Spokane, Washington, 99202

  • Study site

    Vienna, Virginia, 22180

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    Woburn, Massachusetts, 01801

  • Study site

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age

The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age.

Primary Objectives:

Read more
  • To compare pertussis antibody responses induced by Adacel® in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.
  • To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.
  • To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.

Secondary Objective:

  • To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.
Read the detailed description

Study participants will receive a single dose of study vaccine and will then be monitored for safety from the day of vaccination for up to 30 days post-vaccination.

Being tested
Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
Keywords
Tetanus, Diphtheria, Pertussis, Tdap vaccine, Adacel®
Medical subject headings
Tetanus, Diphtheria, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis AdsorbedBiological

    Also called Adacel®

    0.5 mL, Intramuscular

  • Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis AdsorbedBiological

    Also called Adacel®

    0.5 mL, Intramuscular

Study groups in NCT01311557
Study groupRoleWhat they receive
Adacel Vaccine Group 1ExperimentalParticipants enrolled at 10 to < 11 years of age
Receives: Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
Adacel Vaccine Group 2ExperimentalParticipants enrolled at 11 to < 12 years of age
Receives: Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine

    Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).

    Measured: Day 30 post-vaccination

  2. Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine

    Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.

    Measured: 30 days post-vaccination

  3. Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine

    Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were > 2.56 EU/mL for diphtheria or > 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.

    Measured: 30 days post-vaccination

Secondary outcomes (3)

  1. Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine

    Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.

    Measured: Day 0 (pre-vaccination) and 30 days post-vaccination

  2. Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine

    Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).

    Measured: Day 0 (pre-vaccination) and Day 30 post-vaccination

  3. Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine

    Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.

    Measured: Day 0 up to Day 7 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionNov 2011
  4. Study completionJan 2012

Resources

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 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01311557
Sponsor's protocol ID
Td519
Other IDs
U1111-1115-6619
Status last verified
Apr 2016
First submitted
7 Mar 2011
Last updated
8 Apr 2016
Data monitoring committee
No

Publications

  • Marshall GS, Pool V, Greenberg DP, Johnson DR, Sheng X, Decker MD. Safety and immunogenicity of tetanus-diphtheria-acellular pertussis vaccine administered to children 10 or 11 years of age. Clin Vaccine Immunol. 2014 Nov;21(11):1560-4. doi: 10.1128/CVI.00474-14. Epub 2014 Sep 17.

    PubMed 25230939

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed in people with Tetanus and Diphtheria, run by Sanofi at 34 sites in United States.

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 5 inclusion and 16 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 8 Apr 2016). 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?

Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine (time frame: Day 30 post-vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01311557, which also lists 1 linked publication.

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 8 Apr 2016.

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