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

NCT04642079 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: B74710142019-003308-11
• Study Type: interventional
• Target: 839
• Locations: 1 country
• Sites: 43

Brief Summary

This study is designed to evaluate the safety and immunogenicity of 20vPnC in healthy children 15 months through 17 years of age

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Reporting Prompted Local Reactions Within 7 Days After Vaccination

  Local reactions included redness, swelling and, pain at the injection site, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. One measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: \> 0.0 to 2.0 cm, moderate: \>2.0 to 7.0 cm and severe: \>7.0 cm. Pain at the injection site was graded as mild: hurt if gently touched (cohort 1) and did not interfere with activity (cohort 2-4); moderate: hurt if gently touched with crying (cohort 1) and interfered with daily activity (cohort 2-4) and; severe: limited limb movement (cohort 1) and prevented daily activity (cohort 2-4). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.

  Within 7 days after vaccination on Day 1

• Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohort 1

  Systemic events for Cohort 1 included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0-degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.

  Within 7 days after vaccination on Day 1

• Percentage of Participants Reporting Prompted Systemic Events Within 7 Days After Vaccination: Cohorts 2, 3 and 4

  Systemic events for Cohort 2-4 included fever, fatigue, headache, muscle pain and joint pain, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature \>=38.0 degrees C and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevents daily routine activity). 95% CI was based on Clopper and Pearson method.

  Within 7 days after vaccination on Day 1

• Percentage of Participants Reporting Adverse Events (AEs) up to 1 Month After Vaccination

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  From vaccination (on Day 1) up to 1 month after vaccination

• Percentage of Participants Reporting Serious Adverse Events (SAEs) up to 6 Months After Vaccination

  An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.

  From vaccination (on Day 1) up to 6 months after vaccination

• Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 Months After Vaccination

  An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.

  From vaccination (on Day 1) up to 6 months after vaccination

• Geometric Mean Fold Rises (GMFRs) of Pneumococcal Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 1 and 2

  Pneumococcal serotype-specific IgG concentrations were measured from serum samples for the 7 additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on Student's t distribution). Superiority of IgG concentration 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of GMFR was \>1.

  Before vaccination on Day 1 to 1 month after vaccination

• GMFRs of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers for the 7 Additional Serotypes From Before to 1 Month After 20vPnC Vaccination: Cohort 3 and 4

  Pneumococcal serotype-specific OPA titers were measured from serum samples for 7 the additional 20vPnC serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. GMFR = geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding 2-sided 95% CIs (based on the Student's t distribution). Superiority of OPA titers 1 month after 20vPnC to before vaccination for each serotype was demonstrated if the 95% lower CI of the GMFR was \>1.

  Before vaccination on Day 1 to 1 month after vaccination

Secondary Outcomes (8)

• Percentage of Participants With Predefined Levels of Pneumococcal Serotype-Specific IgG Concentrations for the 7 Additional Serotypes at 1 Month After Vaccination in Cohort 1 Only

  At 1 Month after vaccination on Day 1

• Percentage of Participants With >=4-fold Rise in Pneumococcal Serotype-Specific OPA Titers for the 7 Additional Serotypes From Before to 1 Month After Vaccination: Cohorts 2, 3, and 4 Only

  Before vaccination on Day 1 to 1 month after vaccination

• Geometric Mean Concentrations (GMCs) of Pneumococcal Serotype-Specific IgG for the 20vPnC Serotypes Before and 1 Month After Vaccination

  Before vaccination and 1 month after vaccination

• GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 13vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 1 and 2

  Before vaccination on Day 1 to 1 month after vaccination

• GMFRs of Pneumococcal Serotype-Specific IgG Concentrations for the 20vPnC Serotypes From Before to 1 Month After Vaccination: Cohort 3 and 4

  Before vaccination on Day 1 to 1 month after vaccination

Study Arms (4)

Cohort 1: =>15 through 23 months of age

EXPERIMENTAL

20vPnC

Biological: 20vPnC

Cohort 2: 2 through 4 years of age

EXPERIMENTAL

20vPnC

Biological: 20vPnC

Cohort 3: 5 through 9 years of age

EXPERIMENTAL

20vPnC

Biological: 20vPnC

Cohort 4: 10 through 17 years of age

EXPERIMENTAL

20vPnC

Biological: 20vPnC

Interventions

20vPnC BIOLOGICAL

20-valent pneumococcal conjugate vaccine

Cohort 1: =>15 through 23 months of age; Cohort 2: 2 through 4 years of age; Cohort 3: 5 through 9 years of age; Cohort 4: 10 through 17 years of age

Eligibility Criteria

• Age: 15 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (43)

Northwest Arkansas Pediatrics

Fayetteville, Arkansas, 72703, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

The Children's Clinic

Jonesboro, Arkansas, 72401, United States

Location

California Research Foundation

San Diego, California, 92123-1881, United States

Location

Pharmax Research Clinic, Inc.

Miami, Florida, 33126, United States

Location

Bio-Medical Research, LLC

Miami, Florida, 33184, United States

Location

Children's Health Center

Tampa, Florida, 33617, United States

Location

Tekton Research, Inc

Chamblee, Georgia, 30341, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Meridian Clinical Research, LLC

Sioux City, Iowa, 51106, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

Michael W. Simon, M.D., PSC

Lexington, Kentucky, 40517, United States

Location

MedPharmics, LLC

Gulfport, Mississippi, 39503, United States

Location

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, 68803, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68504, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68516, United States

Location

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research, Sioux City

Omaha, Nebraska, 68134, United States

Location

Wr-Crcn, Llc

Henderson, Nevada, 89014, United States

Location

MedPharmic's, LLC

Albuquerque, New Mexico, 87102, United States

Location

Meridian Clinical Research, LLC

Binghamton, New York, 13901, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

Ohio Pediatric Research Association Inc.

Dayton, Ohio, 45414, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States

Location

Lockman & Lubell Pediatric Associates

Fort Washington, Pennsylvania, 19034, United States

Location

Palmetto Pediatrics, PA

North Charleston, South Carolina, 29406, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Tekton Research, Inc

San Antonio, Texas, 78244, United States

Location

Alliance for Multispecialty Research, LLC

Layton, Utah, 84041, United States

Location

Wasatch Pediatrics, Cottonwood Office

Murray, Utah, 84107, United States

Location

Pediatric Care

Provo, Utah, 84604, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc./ Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

CopperView Medical Center

South Jordan, Utah, 84095, United States

Location

J. Lewis Research, Inc. / Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

Wee Care Pediatrics

Syracuse, Utah, 84075, United States

Location

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

Charlottesville, Virginia, 22902, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: December 4, 2020
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: January 22, 2024
• Results First Posted: April 26, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (43)