Clinical trial NCT00255047: Safety and Immune Response of Different Pediatric Combination Vaccines.
Official title: Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Polio
Pertussis
Keywords: Pertussis
Whooping cough
Filamentous Haemagglutinin
Fimbriae Types 2 and 3;
Pertactin
Diphtheria
Tetanus
Poliovirus Types 1, 2, and 3.
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 2167
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 42 days and ≤ 89 days on the day of inclusion
* Born at full term of pregnancy (≥ 36 weeks)
* Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
* Vaccination with a hepatitis B vaccine at least 30 days before inclusion
* Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
* Provide blood sample prior to Dose 1
* Parent or legal representative willing to take rectal temperatures after each vaccination.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination
* Planned participation in another clinical trial during the present trial period
* Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
* Chronic illness that could interfere with trial conduct or completion
* Received blood or blood-derived products since birth
* Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
* Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
* Coagulation disorder contraindicating intramuscular (IM) vaccination
* Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
* Developmental delay or neurological disorder
* Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Primary outcomes:
measure: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
timeFrame: 30 Days post-dose 3 vaccination
measure: Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
timeFrame: 30 Days post-dose 3 vaccination
measure: Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
timeFrame: 30 Days post-dose 3 vaccination.
Secondary outcomes:
Other outcomes:
measure: Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
timeFrame: 7 days post-vaccination 3
Locations:
city: Tuscaloosa
country: United States
state: Alabama
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: Oakland
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oakland
country: United States
state: California
city: Paramount
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Palm Beach Gardens
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Bossier City
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Woburn
country: United States
state: Massachusetts
city: Omaha
country: United States
state: Nebraska
city: Ithaca
country: United States
state: New York
city: Liverpool
country: United States
state: New York
city: Huber Heights
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
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: Amarillo
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Provo
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: St George
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: Marshfield
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chatterjee A, O'Keefe C, Varman M, Klein NP, Luber S, Tomovici A, Noriega F. Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: a randomized, controlled, open-label, multicenter study. Vaccine. 2012 May 14;30(23):3360-8. doi: 10.1016/j.vaccine.2012.03.057. Epub 2012 Apr 1.