Clinical trial NCT00258895: Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: DAPTACEL®
Pentacel™
Diphtheria
Tetanus
Pertussis
Whooping cough
Acellular Pertussis Vaccine Adsorbed
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 649
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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:

1. 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™.
2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.
3. 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.


Eligibility criteria: Inclusion Criteria:

* 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™).

Exclusion Criteria:

* 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.

  b. 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
* 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.

Primary outcomes:
measure: Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination
timeFrame: 0 to 7 days Post-Dose 5
measure: Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination
timeFrame: Day 28 to 48 Post-dose 5
measure: Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination
timeFrame: Day 28 to 48 Post-Dose 5
measure: Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.
timeFrame: Day 0 and between Days 28-48 Post-dose 5
measure: Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination
timeFrame: Day 0 and between Days 28-48 post-dose 5
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Marietta
country: United States
state: Georgia
city: Bardstown,
country: United States
state: Kentucky
city: Bossier City
country: United States
state: Louisiana
city: Rochester
country: United States
state: New York
city: Pembroke
country: United States
state: North Carolina
city: Sylva
country: United States
state: North Carolina
city: Norristown
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Provo
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: LaCrosse
country: United States
state: Wisconsin
city: Marshfield
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: