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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00802867
Other study ID # P3T10
Secondary ID
Status Completed
Phase Phase 4
First received December 4, 2008
Last updated April 12, 2016
Start date February 2004
Est. completion date September 2005

Study information

Verified date April 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

- 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 989
Est. completion date September 2005
Est. primary completion date June 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria :

- 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™.

Exclusion Criteria :

- 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.

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
0.5 mL, Intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).
Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer.
Day 28 to 48 Post-dose 5 No
Other Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose 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. Day 28 to 48 Post-dose 5 No
Other Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Seroprotection is defined as a titer of = 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination Day 28 to 48 Post-dose 5 No
Other Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Pre-dose 5 and Day 28 to 48 Post-dose 5 No
Primary 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.
0 to 3 days post-dose 5 vaccination Yes
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