Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04642079
Collaborator
(none)
839
42
4
16
20
1.2

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
  • Biological: 20vPnC
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
839 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A PHASE 3, SINGLE-ARM TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN 15 MONTHS THROUGH 17 YEARS OF AGE
Actual Study Start Date :
Dec 4, 2020
Actual Primary Completion Date :
Apr 6, 2022
Actual Study Completion Date :
Apr 6, 2022

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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Ages Eligible for Study:
15 Months to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04642079
Other Study ID Numbers:
  • B7471014
  • 2019-003308-11
First Posted:
Nov 24, 2020
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022