Clinical trial NCT00662870: Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
Official title: Safety, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Whooping Cough
Polio
Haemophilus Influenzae Type b
Keywords: DAPTACEL
Diphtheria
Tetanus
Whooping Cough
Polio
Haemophilus influenzae type b
Pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 1941
Sex: ALL
Minimum age (years): 42
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.

Stage I Primary Objectives:

1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines.

Stage II Primary Objectives:

1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

Detailed description: This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL

Eligibility criteria: Inclusion Criteria :

* Healthy infants 2 months of age.
* Infants with at least 37 weeks of gestation at delivery.
* Signed informed consent from parent or guardian.
* Able to attend the scheduled visits and to comply with the study procedure.
* Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.

Exclusion Criteria :

* Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
* Known or suspected hypersensitivity to any component of the study vaccine to be administered.
* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Known HIV-positive mother.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay or neurologic disorders.
* Chronic medical, congenital, developmental or surgical disease.
* Participation in any other experimental vaccine trial.
* Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
* Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine

Primary outcomes:
measure: Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination.
timeFrame: 30 days post-vaccination 3
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville, AR 72703
country: United States
state: Arkansas
city: Jonesboro, AR 72401
country: United States
state: Arkansas
city: Little Rock, AR 72211
country: United States
state: Arkansas
city: Fountain Valley, CA 92708
country: United States
state: California
city: Englewood, CO 80112
country: United States
state: Colorado
city: Norwich, CT 06360
country: United States
state: Connecticut
city: Orlando, FL 32856
country: United States
state: Florida
city: Marietta, GA 30062
country: United States
state: Georgia
city: Chicago, IL 60614
country: United States
state: Illinois
city: Bardstown, KY 40004
country: United States
state: Kentucky
city: Bossier City, LA 71111
country: United States
state: Louisiana
city: Bridgeton, MO 63044
country: United States
state: Missouri
city: Rochester, NY 14620
country: United States
state: New York
city: Chapel Hill, NC 27514
country: United States
state: North Carolina
city: Portland, OR 97201
country: United States
state: Oregon
city: Norristown, PA 19401
country: United States
state: Pennsylvania
city: Pittsburgh, PA 15213
country: United States
state: Pennsylvania
city: Pittsburgh, PA 15241
country: United States
state: Pennsylvania
city: Kingsport, TN 37664
country: United States
state: Tennessee
city: Austin, TX 78758
country: United States
state: Texas
city: Fort Worth, TX 76107
country: United States
state: Texas
city: San Antonio, TX 78205
country: United States
state: Texas
city: Provo, UT 84604
country: United States
state: Utah
city: Spokane, WA 99220
country: United States
state: Washington
city: LaCrosse, WI 54601
country: United States
state: Wisconsin
city: Marshfield, WI 54449
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Guerra FA, Blatter MM, Greenberg DP, Pichichero M, Noriega FR; Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial. Pediatrics. 2009 Jan;123(1):301-12. doi: 10.1542/peds.2007-3317.