Clinical trial NCT00772928: Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
Official title: Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Haemophilus Infection
Pertussis
Polio
Keywords: Pertussis
Whooping cough
Diphtheria
Tetanus
Haemophilus influenzae
Poliovirus Types 1, 2, and 3.
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 1167
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: This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™

Primary Objective - Stage I:

To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).

Primary Objective - Stage II:

To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

Detailed description: This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.

Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.

Eligibility criteria: Inclusion Criteria :

* Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
* Infants with at least 36 weeks of gestation at delivery.
* Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
* Able to attend the scheduled visits and to comply with the study procedures.
* Parent or legal guardian willing to take rectal temperatures during the infant series.
* Parent or legal guardian has access to a telephone.
* Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
* Able to obtain at least 1.5 mL of blood sample prior to Dose 1.

Exclusion Criteria :

* Clinically significant findings on review of systems (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 Human Immunodeficiency Virus (HIV)-positive mother or child.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay or neurologic disorder.
* Chronic medical, congenital, or developmental disease.
* Participation in any other clinical trial.
* 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.
* Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.

Primary outcomes:
measure: Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
timeFrame: 28 to 48 days post-3rd vaccination
measure: Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
timeFrame: 60 Days Post-dose 3
Secondary outcomes:
Other outcomes:
measure: Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™
timeFrame: 0-3 days post- vaccination and entire study period
Locations:
city: Montgomery
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: Rolling Hills Estate
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Bardstown
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Brooklyn
country: United States
state: New York
city: Norristown
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Lacrosse
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: