Clinical trial NCT00761631: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
Official title: A Phase 3, Open Label Trial Evaluating the Safety,Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects \>15months to \<18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

* Negative urine pregnancy test for female subjects who are menstruating.

Exclusion Criteria:

* Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.

Group 4 only:

* Previous vaccination with Prevnar or any other pneumococcal vaccine.
* Pregnant or breastfeeding adolescent females.

Primary outcomes:
measure: Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
timeFrame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
timeFrame: 28 to 42 days after dose 1 for Group 3
measure: Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)
timeFrame: 28 to 42 days after dose 1
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
timeFrame: 28 to 42 days after dose 1 for Group 3 and 4
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
timeFrame: From the day of dose 1 (Day 1) to Day 7 after dose 1
measure: Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
timeFrame: From the day of dose 2 (Day 1) to Day 7 of dose 2
measure: Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
timeFrame: From the day of dose 1 (Day 1) to Day 7 of dose 1
measure: Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
timeFrame: From the day of dose 2 (Day 1) to Day 7 of dose 2
Locations:
city: Benton
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Dekalb
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: St.Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Whitehouse Station
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Clarksville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Galveston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Murray
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: South Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Vienna
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Monroe
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Frenck R Jr, Thompson A, Senders S, Harris-Ford L, Sperling M, Patterson S, Devlin C, Jansen KU, Gruber WC, Emini EA, Scott DA, Gurtman A. 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naive to 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.
citation: Frenck R Jr, Thompson A, Yeh SH, London A, Sidhu MS, Patterson S, Gruber WC, Emini EA, Scott DA, Gurtman A; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a.