Clinical trial NCT00802867: Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Pertussis
Polio
Haemophilus Infection
Keywords: DAPTACEL®
PENTACEL™
Diphtheria
Tetanus
Pertussis
Haemophilus influenzae type b
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 989
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®
timeFrame: 0 to 3 days post-dose 5 vaccination
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.
timeFrame: Day 28 to 48 Post-dose 5
measure: Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose
timeFrame: Day 28 to 48 Post-dose 5
measure: Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
timeFrame: Day 28 to 48 Post-dose 5
measure: Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
timeFrame: Pre-dose 5 and Day 28 to 48 Post-dose 5
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Oakland
country: United States
state: California
city: Torrance
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boston
country: United States
state: Massachusetts
city: Woburn
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Albany
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Sylva
country: United States
state: North Carolina
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Vancouver
country: United States
state: Washington
city: Marshfield
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: