20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
2 other identifiers
interventional
1,997
2 countries
110
Brief Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2020
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedStudy Start
First participant enrolled
May 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2022
CompletedResults Posted
Study results publicly available
December 6, 2023
CompletedDecember 6, 2023
November 1, 2023
2.3 years
May 7, 2020
August 30, 2023
November 13, 2023
Conditions
Outcome Measures
Primary Outcomes (15)
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 days after Dose 1
Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 Days After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 days after Dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Within 7 days after Dose 4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events 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 greater than or equal to (\>=) 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 was 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 Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Systemic events 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 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 was 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 Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Systemic events 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 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 was 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 Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Systemic events 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 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 was 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 Dose 4
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
An AE was any untoward medical occurrence in a participants, 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. AEs reported in this outcome measure excluded local reactions and systemic events.
From Dose 1 to 1 Month after Dose 3
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
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. AEs reported in this outcome measure excluded local reactions and systemic events.
From Dose 4 to 1 month after Dose 4
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months Following Dose 4
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
From Dose 1 to 6 months following Dose 4
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months Following Dose 4
An NDCMC was defined as a significant 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 Dose 1 to 6 months following Dose 4
Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per mL (mcg/mL), for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
1 month after Dose 3
Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Concentrations of anticapsular IgG for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in all participants at 1 month after Dose 4 using the Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. Assay result below LLOQ was set to 0.5\*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).
From Dose 1 to 6 months following Dose 4
Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Concentration of antibody to diphtheria toxoid (predefined level ≥0.1 IU/mL), tetanus toxoid (predefined level ≥0.1 IU/mL), IgG antibodies to pertussis antigens (pertussis toxin, filamentous hemagglutinin and pertactin, each with the predefined level as the 5th percentile observed in the 13vPnC group), hepatitis B antibody (in milli-international units per mL \[mIU/mL\]) (predefined level ≥10 mIU/mL), neutralizing antibody (NA) titers to poliovirus types 1, 2, and 3 (predefined level NA titer ≥1:8), Haemophilus influenzae type b (Hib) (≥0.15 μg/mL) were determined on subsets of sera collected at the immunogenicity time point 1 month after Dose 3. The antibody levels were measured by a validated multiplex Luminex immunoassay. The concomitant immune responses were measured on random subsets.
1 month after Dose 3
Secondary Outcomes (12)
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
1 month after Dose 3
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
1 month after Dose 4
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
1 month after Dose 3
Serotype-specific OPA GMTs at 1 Month After Dose 4
1 month after Dose 4
Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
1 month after Dose 3 to before Dose 4
- +7 more secondary outcomes
Study Arms (2)
20-valent pneumococcal conjugate vaccine
EXPERIMENTALPneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
ACTIVE COMPARATORPneumococcal conjugate vaccine
Interventions
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Eligibility Criteria
You may qualify if:
- Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for 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 receipt of \>1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (110)
Children's of Alabama
Birmingham, Alabama, 35233, United States
UAB Pediatric Primary Care Clinic at Children's of Alabama
Birmingham, Alabama, 35233, United States
Southeastern Pediatric Associates
Dothan, Alabama, 36305, United States
MedPharmics, LLC
Phoenix, Arizona, 85015, United States
Northwest Arkansas Pediatrics
Fayetteville, Arkansas, 72703, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Gardens Medical Center
Bell Gardens, California, 90201, United States
Coast Clinical Research, LLC
Bellflower, California, 90706, United States
Priti Desai, M.D. Inc.
Covina, California, 91723, United States
Universal Biopharma Research Institute Inc.
Fresno, California, 93703, United States
Matrix Clinical Research
Gardena, California, 90247, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250, United States
Kaiser Permanente Oakland
Oakland, California, 94611, United States
Orange County Research Institute
Ontario, California, 91762, United States
Center for Clinical Trials of San Gabriel
West Covina, California, 91790, United States
Children's Colorado Health Pavilion (Child Health Clinic)
Aurora, Colorado, 80011, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, 80906, United States
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, 80922, United States
Gentle Medicine Associates
Boynton Beach, Florida, 33435, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Benton Pediatrics
Gainesville, Florida, 32653, United States
Qway Research
Hialeah, Florida, 33010, United States
Next Phase Research Alliance
Homestead, Florida, 33030, United States
Axcess Medical Research
Loxahatchee Groves, Florida, 33470, United States
Acevedo Clinical Research Associates
Miami, Florida, 33142, United States
Suncoast Research Associates, LLC
Miami, Florida, 33173, United States
Bio-Medical Research, LLC
Miami, Florida, 33184, United States
Crystal Biomedical Research, LLC
Miami Lakes, Florida, 33014, United States
Children's Health Center
Tampa, Florida, 33617, United States
Tekton Research, Inc
Chamblee, Georgia, 30341, United States
Uptown Pediatrics
Columbus, Georgia, 31901, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Meridian Clinical Research
Macon, Georgia, 31210, United States
Omega Pediatrics
Roswell, Georgia, 30076, United States
Idaho Falls Pediatrics
Ammon, Idaho, 83406, United States
Idaho Falls Pediatrics
Idaho Falls, Idaho, 83402, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Family First Medical Center
Idaho Falls, Idaho, 83404, United States
Snake River Research, PLLC
Idaho Falls, Idaho, 83404, United States
The Pediatric Center
Idaho Falls, Idaho, 83404, United States
Saltzer Health
Nampa, Idaho, 83686, United States
ASR, LLC
Nampa, Idaho, 83687, United States
The Iowa Clinic
Ankeny, Iowa, 50023, United States
Blank Children's Pediatric Clinic
Des Moines, Iowa, 50309, United States
Unity Point Health
Des Moines, Iowa, 50309, United States
The Iowa Clinic
West Des Moines, Iowa, 50266, United States
Alliance for Multispecialty Research, LLC
El Dorado, Kansas, 67042, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Michael W. Simon, MD, PSC
Lexington, Kentucky, 40517, United States
Novak Center for Children's Health
Louisville, Kentucky, 40202, United States
Brownsboro Park Pediatrics
Louisville, Kentucky, 40207, United States
Velocity Clinical Research at Primary Pediatrics, Macon
Baton Rouge, Louisiana, 70809, United States
Benchmark Research
Covington, Louisiana, 70433, United States
ACC Pediatric Research
Haughton, Louisiana, 71037, United States
Velocity Clinical Research, Covington
Metairie, Louisiana, 70006, United States
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201, United States
The Pediatric Center of Frederick, LLC
Frederick, Maryland, 21702, United States
MedPharmics, LLC
Gulfport, Mississippi, 39503, United States
Boeson Research
Missoula, Montana, 59804, United States
Meridian Clinical Research
Hastings, Nebraska, 68901, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68516, United States
Children's Physicians Dundee
Omaha, Nebraska, 68132, United States
Medpharmics
Albuquerque, New Mexico, 87102, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Child Health Care Associates
East Syracuse, New York, 13057, United States
Smart Medical Research, Inc
Jackson Heights, New York, 11372, United States
Child Health Care Associates
Liverpool, New York, 13090, United States
ECU Physicians Adult and Pediatric Health Center
Greenville, North Carolina, 27834, United States
ECU Physicians Pediatric Outpatient Clinic
Greenville, North Carolina, 27834, United States
Leo Jenkins Cancer Center Pharmacy
Greenville, North Carolina, 27834, United States
Dayton Clinical Research
Dayton, Ohio, 45409, United States
Ohio Pediatric Research Association, Inc.
Dayton, Ohio, 45414, United States
Pediatric Associates of Fairfield
Fairfield, Ohio, 45014, United States
Senders Pediatrics
South Euclid, Ohio, 44121, United States
Pediatric Medical Associates
East Norriton, Pennsylvania, 19401, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506, United States
Lockman & Lubell Pediatric Associates
Fort Washington, Pennsylvania, 19034, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, 29406-9170, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, 57105, United States
Sanford 69th & Louise Family Medicine
Sioux Falls, South Dakota, 57108, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Premier Medical Group
Clarksville, Tennessee, 37040, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38104, United States
Coastal Bend Clinical Research
Corpus Christi, Texas, 78413, United States
Kool Kids Pediatrics
Houston, Texas, 77065, United States
La Providence Pediatrics Clinic
Houston, Texas, 77071, United States
Houston Clinical Research Associates
Houston, Texas, 77090, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Diagnostic Clinic of Longview
Longview, Texas, 75605, United States
Ashley Pediatrics Day and Night Clinic
McAllen, Texas, 78503, United States
Dr. Ruben Aleman & Associates
McAllen, Texas, 78504, United States
Tekton Research, Inc
San Antonio, Texas, 78244, United States
Wee Care Pediatrics
Kaysville, Utah, 84037, United States
Wee Care Pediatrics
Layton, Utah, 84041, United States
Wasatch Pediatrics, Cottonwood Office
Murray, Utah, 84107, United States
Wee Care Pediatrics
Roy, Utah, 84067, United States
Dixie Pediatrics
St. George, Utah, 84790, United States
Wee Care Pediatrics
Syracuse, Utah, 84075, United States
Pediatric Associates of Charlottesville, PLC
Charlottesville, Virginia, 22902, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
The Vancouver Clinic, Inc
Vancouver, Washington, 98664, United States
San Miguel Medical
Trujillo Alto, PR, 00976, Puerto Rico
Cooperativa de Facultad Medica Sanacoop DBA Instituto Sanacoop
Bayamón, 00961, Puerto Rico
Clinical Research Puerto Rico
Guayama, 00784, Puerto Rico
Hispanic Alliance for Clinical and Translational Research
San Juan, 00935, Puerto Rico
San Juan Hospital
San Juan, 00935, Puerto Rico
Related Publications (3)
Senders S, Korbal P, Kline M, Tamimi N, Thompson A, Drozd J, Cutler MW, Giardina PC, Trammel J, Lei L, Peng Y, Watson W, McElwee K. Immunogenicity and safety of concomitant vaccines given with 20-valent pneumococcal conjugate vaccine in healthy infants. Vaccine. 2025 Dec 5;68:127916. doi: 10.1016/j.vaccine.2025.127916. Epub 2025 Nov 3.
PMID: 41187484DERIVEDSenders S, Klein NP, Tamimi N, Thompson A, Baugher G, Trammel J, Peng Y, Giardina P, Scully IL, Pride M, Center KJ, Gruber WC, Scott DA, Watson W. A Phase Three Study of the Safety and Immunogenicity of a Four-dose Series of 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2024 Jun 1;43(6):596-603. doi: 10.1097/INF.0000000000004334. Epub 2024 Mar 26.
PMID: 38535409DERIVEDMt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19.
PMID: 37846456DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2020
First Posted
May 11, 2020
Study Start
May 20, 2020
Primary Completion
September 2, 2022
Study Completion
September 2, 2022
Last Updated
December 6, 2023
Results First Posted
December 6, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.