DiphtheriaPhase 4NCT00802867
Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
A Phase 4 study testing Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 19 sites in United States.
Trial summary
Objectives: To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. 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?
- Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 989 participants
- Where
- 19 sitesUnited States
- Study dates
- Feb 2004to Sep 2005
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged ≥ 4 years and 6 years.
- Signed and dated Investigational Review Board-approved informed consent from a parent or legally authorized representative.
- 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 4th dose in Study 494-01 or Study 494-03, consisting of four previous administrations of PENTACEL™.
Who cannot join
- Received a 5th dose of DTaP-containing vaccine scheduled at 4 to 6 years of age.
- Serious underlying chronic disease, including, but not limited to:
- Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or
- Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration.
- Known or suspected primary or acquired disease of the immune system.
- Administration of immune globulin or other blood products within the last 3 months, or injected or oral corticosteroids or other immunomodulatory therapy within 6 weeks of the study vaccine. 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.
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- Had allergy shots started or had changes in regimen or dosing of allergy shots within the last 4 weeks.
- Receipt of any other vaccine within the past 30 days, or planning to receive another vaccine within 30 days before the Visit 2 blood draw, with the exclusion of M-M-R®II and IPV.
- 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.
- Temporary contraindications:
- A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:
- Oral temperature ≥ 100.4°F (≥ 38.0ºC) (Note: A tympanic thermometer should not be used).
- Any moderate or severe acute illness with or without fever.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Albany, New York, 12208
Study site
Atlanta, Georgia, 30322
Study site
Boston, Massachusetts, 02115
Study site
Chapel Hill, North Carolina, 27514
Study site
Jonesboro, Arkansas, 72401
Study site
Layton, Utah, 84041
Study site
Little Rock, Arkansas, 72205
Study site
Marshfield, Wisconsin, 54449
Study site
Nashville, Tennessee, 37232
Study site
Oakland, California, 94612
Study site
Omaha, Nebraska, 68131
Study site
Orlando, Florida, 32806
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Rochester, New York, 14620
Study site
San Antonio, Texas, 78205
Study site
Sylva, North Carolina, 28779
Study site
Torrance, California, 90502
Study site
Vancouver, Washington, 98664
Study site
Woburn, Massachusetts, 01801
About this study
Official title: Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)
Objectives:
- To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
- To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
Read the detailed description
This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio, Haemophilus Infection
- Being tested
- Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
- Keywords
- DAPTACEL®, PENTACEL™, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)Biological
Also called DAPTACEL®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine. Receives: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®
Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.
Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
Measured: 0 to 3 days post-dose 5 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startFeb 2004
- Primary completionJun 2005
- Study completionSep 2005
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 989 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802867
- Sponsor's protocol ID
- P3T10
- Status last verified
- Apr 2016
- First submitted
- 4 Dec 2008
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)
- ClinicalTrials.gov ID
- NCT00802867
- Acronym / sponsor ID
- P3T10
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio, Haemophilus Infection
- Keywords
- DAPTACEL®, PENTACEL™, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 989 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 12 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
- To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
Detailed description
This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged ≥ 4 years and 6 years.
- Signed and dated Investigational Review Board-approved informed consent from a parent or legally authorized representative.
- 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 4th dose in Study 494-01 or Study 494-03, consisting of four previous administrations of PENTACEL™.
Key exclusion criteria (16 listed)
- Received a 5th dose of DTaP-containing vaccine scheduled at 4 to 6 years of age.
- Serious underlying chronic disease, including, but not limited to:
- Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or
- Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration.
- 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 |
|---|---|---|
| Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)Also: DAPTACEL®0.5 mL, Intramuscular | Biological | 1 |
Primary outcome
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®
Time frame: 0 to 3 days post-dose 5 vaccination
Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
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 Monitor study director
Sanofi Pasteur Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 19 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 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 19 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 12 Jan 2010). 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 With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® (time frame: 0 to 3 days post-dose 5 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 14 Apr 2016.