Clinical trial NCT00444457: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-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
Keywords: Vaccine
Infants
Pneumococcal Conjugate Vaccines
Vaccines, Pneumococcal
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 1712
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 will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.


Eligibility criteria: Inclusion criteria:

* Healthy 2 month old infants
* Available for the duration of the study and reachable by telephone
* Able to complete two blood drawing procedures during the study

Exclusion criteria:

* Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
* Bleeding disorder, immune deficiency or significant chronic or congenital disease
* Previous receipt of blood products or immune globulin

Primary outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series
timeFrame: 1 Month after the infant series (7 Months of age)
measure: Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
measure: Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
measure: Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
Other outcomes:
measure: Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 7 days after dose (2 months of age)
measure: Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 7 days after dose (4 months of age)
measure: Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 7 days after dose (6 months of age)
measure: Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)
timeFrame: Within 7 days after dose (12 months of age)
measure: Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 7 days after dose (2 months of age)
measure: Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 7 days after dose (4 months of age)
measure: Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 7 days after dose (6 months of age)
measure: Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)
timeFrame: Within 7 days after dose (12 months of age)
Locations:
city: Benton
country: United States
state: Arkansas
city: Conway
country: United States
state: Arkansas
city: Fayetteville
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: North Little Rock
country: United States
state: Arkansas
city: Downey
country: United States
state: California
city: Fontana
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Moreno Valley
country: United States
state: California
city: Paramount
country: United States
state: California
city: Riverside
country: United States
state: California
city: Rolling Hills Estates
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Palm Beach Gardens
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Nampa
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Dekalb
country: United States
state: Illinois
city: Bardstown
country: United States
state: Kentucky
city: Crestview Hills
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Fall River
country: United States
state: Massachusetts
city: Jamaica Plain
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Whitehouse Station
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Fishkill
country: United States
state: New York
city: Hopewell Jct
country: United States
state: New York
city: Ithaca
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Sylva
country: United States
state: North Carolina
city: Bismark
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Huber Heights
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Kittanning
country: United States
state: Pennsylvania
city: Latrobe
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Clarksville
country: United States
state: Tennessee
city: Franklin
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Galveston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Murray
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: Vienna
country: United States
state: Virginia
city: Vancouver
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: LaCrosse
country: United States
state: Wisconsin
city: Marshfield
country: United States
state: Wisconsin
city: Monroe
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Payton T, Girgenti D, Frenck RW, Patterson S, Love J, Razmpour A, Sidhu MS, Emini EA, Gruber WC, Scott DA. Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.
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.