DiphtheriaPhase 3NCT00258895
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
A Phase 3 study testing DAPTACEL®: DTaP in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 22 sites in United States.
Trial summary
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DAPTACEL®: DTaP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 22 sitesUnited States
- Study dates
- Mar 2005to Apr 2007
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged ≥ 4 and < 7 years from date of birth at the time of study vaccination
- Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB
- Judged to be in good health on the basis of reported medical history and physical examination
- Able and willing to attend the scheduled visits and to comply with the study procedures
- Has documented complete infant series and the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™).
Who cannot join
- Received a 5th dose of DTaP-containing vaccine
- a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age.
- For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age
- Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination
- Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination
- Known or suspected primary or acquired disease of the immune system
Show all 13Show fewer
- Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment
- Had allergy shots started or had changes in regimen or dosing of allergy shots within 4 weeks prior to study vaccination
- Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable)
- Any other condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine
- Enrolled in another vaccine trial
- Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months
- Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Study site
Bardstown, Kentucky
Study site
Bossier City, Louisiana
Study site
Centennial, Colorado
Study site
Fayetteville, Arkansas
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Jonesboro, Arkansas
Study site
Kingsport, Tennessee
Study site
La Crosse, Wisconsin
Study site
Little Rock, Arkansas
Study site
Marietta, Georgia
Study site
Marshfield, Wisconsin
Study site
Norristown, Pennsylvania
Study site
Norwich, Connecticut
Study site
Pembroke, North Carolina
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Provo, Utah
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
Spokane, Washington
Study site
Sylva, North Carolina
About this study
Official title: Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®
Primary Objectives:
- To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
- To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
Read more
Observational Objectives:
- To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
- To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.
- To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Being tested
- DAPTACEL®: DTaP
- Keywords
- DAPTACEL®, Pentacel™, Diphtheria, Tetanus, Pertussis, Whooping cough, Acellular Pertussis Vaccine Adsorbed
- 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.
DAPTACEL®: DTaPBiological
Also called DAPTACEL®
0.5 mL, Intramuscular
DAPTACEL®: DTaPBiological
Also called DAPTACEL®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| DAPTACEL Primed | Experimental | Participants received Daptacel in Study P3T06. Receives: Biological: DAPTACEL®: DTaP |
| Pentacel Primed | Experimental | Participants received Pentacel in Study P3T06 Receives: Biological: DAPTACEL®: DTaP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination
Measured: 0 to 7 days Post-Dose 5
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination
Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.
Measured: Day 28 to 48 Post-dose 5
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination
Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.
Measured: Day 28 to 48 Post-Dose 5
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.
Measured: Day 0 and between Days 28-48 Post-dose 5
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination
Measured: Day 0 and between Days 28-48 post-dose 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2006
- Study completionApr 2007
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 649 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
- NCT00258895
- Sponsor's protocol ID
- P3T11
- Status last verified
- Apr 2016
- First submitted
- 24 Nov 2005
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®
- ClinicalTrials.gov ID
- NCT00258895
- Acronym / sponsor ID
- P3T11
- Conditions
- Diphtheria, Tetanus, Pertussis
- Keywords
- DAPTACEL®, Pentacel™, Diphtheria, Tetanus, Pertussis, Whooping cough, Acellular Pertussis Vaccine Adsorbed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Posted 28 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
- To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
Observational Objectives:
- To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
- To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.
- To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAPTACEL Primed | Experimental | Biological: DAPTACEL®: DTaPParticipants received Daptacel in Study P3T06. |
| Pentacel Primed | Experimental | Biological: DAPTACEL®: DTaPParticipants received Pentacel in Study P3T06 |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged ≥ 4 and < 7 years from date of birth at the time of study vaccination
- Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB
- Judged to be in good health on the basis of reported medical history and physical examination
- Able and willing to attend the scheduled visits and to comply with the study procedures
- Has documented complete infant series and the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™).
Key exclusion criteria (13 listed)
- Received a 5th dose of DTaP-containing vaccine
- a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age.
- Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination
- Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination
- Known or suspected primary or acquired disease of the immune system
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 |
|---|---|---|
| DAPTACEL®: DTaPAlso: DAPTACEL®0.5 mL, Intramuscular | Biological | DAPTACEL Primed |
| DAPTACEL®: DTaPAlso: DAPTACEL®0.5 mL, Intramuscular | Biological | Pentacel Primed |
Primary outcome
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination
Time frame: 0 to 7 days Post-Dose 5
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination
Time frame: Day 28 to 48 Post-dose 5
Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination
Time frame: Day 28 to 48 Post-Dose 5
Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.
Time frame: Day 0 and between Days 28-48 Post-dose 5
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination
Time frame: Day 0 and between Days 28-48 post-dose 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DAPTACEL®: DTaP in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 22 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 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 14 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 22 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 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 28 Sep 2009). 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?
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination (time frame: 0 to 7 days Post-Dose 5). The study lists 5 primary outcomes in all. 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 14 Apr 2016.