Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
Study Details
Study Description
Brief Summary
This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1: =>15 through 23 months of age 20vPnC |
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine
|
Experimental: Cohort 2: 2 through 4 years of age 20vPnC |
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine
|
Experimental: Cohort 3: 5 through 9 years of age 20vPnC |
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine
|
Experimental: Cohort 4: 10 through 17 years of age 20vPnC |
Biological: 20vPnC
20-valent pneumococcal conjugate vaccine
|
Outcome Measures
Primary Outcome Measures
- The percentage of participants reporting prompted local reactions within 7 days after vaccination [Day 7]
Prompted local reactions after vaccination. All cohorts: redness, swelling, and pain at the injection site
- The percentage of participants reporting prompted systemic events within 7 days after vaccination [Day 7]
Prompted systemic events after vaccination. Cohort 1: Fever, decreased appetite, drowsiness/increased sleep, and irritability. Cohorts 2 through 4: Fever, fatigue, headache, muscle pain, and joint pain
- The percentage of participants reporting Adverse Events (AEs) up to 1 month after vaccination [1 month after vaccination]
AEs occurring from vaccination up to 1 month after vaccination
- The percentage of participants reporting Serious Adverse Events (SAEs) up to 6 months after vaccination [6 months after vaccination]
SAEs occurring from vaccination up to 6 months after vaccination
- The percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after vaccination [6 months after vaccination]
NDCMCs occurring from vaccination up to 6 months after vaccination
- Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 7 additional serotypes 1 month after vaccination [1 month after vaccination]
IgG GMFRs from before to 1 month after vaccination for Cohorts 1 and 2
- Opsonophagocytic activity (OPA) GMFRs for the 7 additional serotypes 1 month after vaccination [1 month after vaccination]
OPA GMFRs from before to 1 month after vaccination for Cohorts 3 and 4
Secondary Outcome Measures
- Percentage of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes at 1 month after vaccination in Cohort 1 only [1 month after vaccination]
Predefined IgG concentrations from before to 1 month after vaccination in Cohort 1 only
- Percentage of participants with ≥4-fold rise in serotype-specific OPA titers for the 7 additional serotypes from before to 1 month after vaccination in Cohorts 2, 3, and 4 only [from before to 1 month after vaccination]
≥4-fold rise in OPA titers from before to 1 month after vaccination in Cohorts 2, 3, and 4 only
- IgG Geometric Mean Concentrations (GMCs) for the 20vPnC serotypes before and 1 month after vaccination [before and 1 month after vaccination]
IgG GMCs before and 1 month after vaccination
- IgG GMFRs for the 13vPnC serotypes from before to 1 month after vaccination [before to 1 month after vaccination]
IgG GMFRs from before to 1 month after vaccination for Cohorts 1 and 2
- IgG GMFRs for the 20vPnC serotypes from before to 1 month after vaccination [before to 1 month after vaccination]
IgG GMFRs from before to 1 month after vaccination in Cohorts 3 and 4
- OPA Geometric Mean Titers (GMTs) for the 20vPnC serotypes before and 1 month after vaccination [before and 1 month after vaccination]
OPA GMTs before and 1 month after vaccination
- OPA GMFRs for the 20vPnC serotypes from before to 1 month after vaccination [before to 1 month after vaccination]
OPA GMFRs from before to 1 month after vaccination in Cohorts 1 and 2
- OPA GMFRs for the 13vPnC serotypes from before to 1 month after vaccination [before to 1 month after vaccination]
OPA GMFRs from before to 1 month after vaccination in Cohorts 3 and 4
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female children ≥15 months to <18 years of age at the time of consent.
-
Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
-
For children <5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment into the study
Exclusion Criteria:
-
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
-
Major known congenital malformation or serious chronic disorder
-
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
-
Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
-
Cohorts 3 and 4: Pregnant or breastfeeding female participants
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northwest Arkansas Pediatrics | Fayetteville | Arkansas | United States | 72703 |
2 | The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | United States | 72401 |
3 | The Children's Clinic | Jonesboro | Arkansas | United States | 72401 |
4 | California Research Foundation | San Diego | California | United States | 92123-1881 |
5 | Pharmax Research Clinic, Inc. | Miami | Florida | United States | 33126 |
6 | Bio-Medical Research, LLC | Miami | Florida | United States | 33184 |
7 | Children's Health Center | Tampa | Florida | United States | 33617 |
8 | Tekton Research, Inc. | Chamblee | Georgia | United States | 30341 |
9 | Clinical Research Prime | Idaho Falls | Idaho | United States | 83404 |
10 | Meridian Clinical Research, LLC | Sioux City | Iowa | United States | 51106 |
11 | Alliance for Multispecialty Research, LLC | Newton | Kansas | United States | 67114 |
12 | Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | United States | 40004 |
13 | Michael W. Simon, M.D., PSC | Lexington | Kentucky | United States | 40517 |
14 | MedPharmics, LLC | Gulfport | Mississippi | United States | 39503 |
15 | Meridian Clinical Research, LLC | Grand Island | Nebraska | United States | 68803 |
16 | Midwest Children's Health Research Institute | Lincoln | Nebraska | United States | 68504 |
17 | Midwest Children's Health Research Institute | Lincoln | Nebraska | United States | 68516 |
18 | Meridian Clinical Research, LLC | Norfolk | Nebraska | United States | 68701 |
19 | Meridian Clinical Research, LLC | Omaha | Nebraska | United States | 68134 |
20 | Wr-Crcn, Llc | Henderson | Nevada | United States | 89014 |
21 | MedPharmic's, LLC | Albuquerque | New Mexico | United States | 87102 |
22 | Meridian Clinical Research, LLC | Binghamton | New York | United States | 13901 |
23 | Dayton Clinical Research | Dayton | Ohio | United States | 45406 |
24 | Ohio Pediatric Research Association Inc. | Dayton | Ohio | United States | 45414 |
25 | PriMed Clinical Research | Dayton | Ohio | United States | 45419 |
26 | Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | United States | 16506 |
27 | Lockman & Lubell Pediatric Associates | Fort Washington | Pennsylvania | United States | 19034 |
28 | Palmetto Pediatrics, PA | North Charleston | South Carolina | United States | 29406 |
29 | Benchmark Research | Austin | Texas | United States | 78705 |
30 | University of Texas Medical Branch | Galveston | Texas | United States | 77555 |
31 | Tekton Research, Inc. | San Antonio | Texas | United States | 78244 |
32 | Wee Care Pediatrics | Layton | Utah | United States | 84041 |
33 | Wasatch Pediatrics, Cottonwood Office | Murray | Utah | United States | 84107 |
34 | Pediatric Care | Provo | Utah | United States | 84604 |
35 | JBR Clinical Research | Salt Lake City | Utah | United States | 84107 |
36 | J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | United States | 84109 |
37 | J. Lewis Research, Inc./ Foothill Family Clinic South | Salt Lake City | Utah | United States | 84121 |
38 | CopperView Medical Center | South Jordan | Utah | United States | 84095 |
39 | J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah | United States | 84095 |
40 | Wee Care Pediatrics | Syracuse | Utah | United States | 84075 |
41 | Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice) | Charlottesville | Virginia | United States | 22902 |
42 | Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | United States | 22902 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B7471014
- 2019-003308-11