Clinical trial NCT00373958: Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-08
Enrollment: 666
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.


Eligibility criteria: Inclusion Criteria:

* Healthy 2-month-old infants.
* Available for the entire study period.

Exclusion criteria:

* Previous vaccination with any vaccine before the start of the study.
* Known contraindication to vaccination.

Primary outcomes:
measure: Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
timeFrame: One month after the 3-dose infant series (7 months of age)
measure: Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
timeFrame: 1 Month After the Toddler Dose
measure: Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
timeFrame: One Month After the Infant Series (7 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events
timeFrame: Within 7 days after each dose
measure: Percentage of Participants Reporting Pre-specified Local Reactions
timeFrame: Within 7 days after each dose
Secondary outcomes:
measure: Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
timeFrame: One month after toddler dose (13 to 16 months of age)
measure: Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
timeFrame: one month after the toddler dose
measure: Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
timeFrame: one month after the toddler dose
measure: Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
timeFrame: one month after the toddler dose
measure: Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
timeFrame: One month after infant series and one month after toddler dose
measure: Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
timeFrame: one month after the infant series and the toddler dose
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: Downey
country: United States
state: California
city: Fontana
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Paramount
country: United States
state: California
city: Riverside
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Bronx
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Latrobe
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: The Woodlands
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Provo
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
citation: Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.