20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

November 13, 2023 updated by: Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

Study Overview

Study Type

Interventional

Enrollment (Actual)

1997

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bayamon, Puerto Rico, 00961
        • Cooperativa de Facultad Medica Sanacoop DBA Instituto Sanacoop
      • Guayama, Puerto Rico, 00784
        • Clinical Research Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Hispanic Alliance for Clinical and Translational Research
      • San Juan, Puerto Rico, 00935
        • San Juan Hospital
      • Trujillo Alto, Puerto Rico, 00976
        • San Miguel Medical
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's of Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Pediatric Primary Care Clinic at Children's of Alabama
      • Dothan, Alabama, United States, 36305
        • Southeastern Pediatric Associates
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • MedPharmics, LLC
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Northwest Arkansas Pediatrics
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro, P.A.
    • California
      • Bell Gardens, California, United States, 90201
        • Gardens Medical Center
      • Bellflower, California, United States, 90706
        • Coast Clinical Research, LLC
      • Covina, California, United States, 91723
        • Priti Desai, M.D. Inc.
      • Fresno, California, United States, 93703
        • Universal Biopharma Research Institute Inc.
      • Gardena, California, United States, 90247
        • Matrix Clinical Research
      • Hawthorne, California, United States, 90250
        • Advanced Investigative Medicine, Inc.
      • Oakland, California, United States, 94611
        • Kaiser Permanente Oakland
      • Ontario, California, United States, 91762
        • Orange County Research Institute
      • West Covina, California, United States, 91790
        • Center for Clinical Trials of San Gabriel
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80011
        • Children's Colorado Health Pavilion (Child Health Clinic)
      • Colorado Springs, Colorado, United States, 80906
        • Optumcare Colorado Springs, LLC
      • Colorado Springs, Colorado, United States, 80922
        • Optumcare Colorado Springs, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Gentle Medicine Associates
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Gainesville, Florida, United States, 32653
        • Benton Pediatrics
      • Hialeah, Florida, United States, 33010
        • Qway Research
      • Homestead, Florida, United States, 33030
        • Next Phase Research Alliance
      • Loxahatchee Groves, Florida, United States, 33470
        • Axcess Medical Research
      • Miami, Florida, United States, 33184
        • Bio-Medical Research, LLC
      • Miami, Florida, United States, 33142
        • Acevedo Clinical Research Associates
      • Miami, Florida, United States, 33173
        • Suncoast Research Associates, LLC
      • Miami Lakes, Florida, United States, 33014
        • Crystal Biomedical Research, LLC
      • Tampa, Florida, United States, 33617
        • Children's Health Center
    • Georgia
      • Chamblee, Georgia, United States, 30341
        • Tekton Research, Inc
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Columbus, Georgia, United States, 31901
        • Uptown Pediatrics
      • Macon, Georgia, United States, 31210
        • Meridian Clinical Research
      • Roswell, Georgia, United States, 30076
        • Omega Pediatrics
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Idaho Falls Pediatrics
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research, PLLC
      • Idaho Falls, Idaho, United States, 83404
        • The Pediatric Center
      • Idaho Falls, Idaho, United States, 83402
        • Idaho Falls Pediatrics
      • Idaho Falls, Idaho, United States, 83404
        • Family First Medical Center
      • Nampa, Idaho, United States, 83687
        • ASR, LLC
      • Nampa, Idaho, United States, 83686
        • Saltzer Health
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • The Iowa Clinic
      • Des Moines, Iowa, United States, 50309
        • Blank Children's Pediatric Clinic
      • Des Moines, Iowa, United States, 50309
        • Unity Point Health
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/Adult Research
      • Lexington, Kentucky, United States, 40517
        • Michael W. Simon, MD, PSC
      • Louisville, Kentucky, United States, 40207
        • Brownsboro Park Pediatrics
      • Louisville, Kentucky, United States, 40202
        • Novak Center for Children's Health
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Velocity Clinical Research at Primary Pediatrics, Macon
      • Covington, Louisiana, United States, 70433
        • Benchmark Research
      • Haughton, Louisiana, United States, 71037
        • ACC Pediatric Research
      • Metairie, Louisiana, United States, 70006
        • Velocity Clinical Research, Covington
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore, Center for Vaccine Development and Global Health
      • Frederick, Maryland, United States, 21702
        • The Pediatric Center of Frederick, LLC
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • MedPharmics, LLC
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Meridian Clinical Research
      • Lincoln, Nebraska, United States, 68516
        • Midwest Children's Health Research Institute
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute
      • Omaha, Nebraska, United States, 68132
        • Children's Physicians Dundee
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • MedPharmics
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY downstate Medical Center
      • East Syracuse, New York, United States, 13057
        • Child Health Care Associates
      • Jackson Heights, New York, United States, 11372
        • Smart Medical Research, Inc
      • Liverpool, New York, United States, 13090
        • Child Health Care Associates
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • ECU Physicians Adult and Pediatric Health Center
      • Greenville, North Carolina, United States, 27834
        • ECU Physicians Pediatric Outpatient Clinic
      • Greenville, North Carolina, United States, 27834
        • Leo Jenkins Cancer Center Pharmacy
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Dayton Clinical Research
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association, Inc.
      • Fairfield, Ohio, United States, 45014
        • Pediatric Associates of Fairfield
      • South Euclid, Ohio, United States, 44121
        • Senders Pediatrics
    • Pennsylvania
      • East Norriton, Pennsylvania, United States, 19401
        • Pediatric Medical Associates
      • Erie, Pennsylvania, United States, 16506
        • Allegheny Health and Wellness Pavilion
      • Fort Washington, Pennsylvania, United States, 19034
        • Lockman & Lubell Pediatric Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research
      • North Charleston, South Carolina, United States, 29406-9170
        • Palmetto Pediatrics, PA
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Children's Specialty Clinic
      • Sioux Falls, South Dakota, United States, 57108
        • Sanford 69th & Louise Family Medicine
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Clarksville, Tennessee, United States, 37040
        • Premier Medical Group
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Memphis, Tennessee, United States, 38104
        • LeBonheur Children's Hospital
    • Texas
      • Corpus Christi, Texas, United States, 78413
        • Coastal Bend Clinical Research
      • Houston, Texas, United States, 77090
        • Houston Clinical Research Associates
      • Houston, Texas, United States, 77065
        • Kool Kids Pediatrics
      • Houston, Texas, United States, 77071
        • La Providence Pediatrics Clinic
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • Longview, Texas, United States, 75605
        • Diagnostic Clinic of Longview
      • McAllen, Texas, United States, 78503
        • Ashley Pediatrics Day and Night Clinic
      • McAllen, Texas, United States, 78504
        • Dr. Ruben Aleman & Associates
      • San Antonio, Texas, United States, 78244
        • Tekton Research, Inc
    • Utah
      • Kaysville, Utah, United States, 84037
        • Wee Care Pediatrics
      • Layton, Utah, United States, 84041
        • Wee Care Pediatrics
      • Murray, Utah, United States, 84107
        • Wasatch Pediatrics, Cottonwood Office
      • Roy, Utah, United States, 84067
        • Wee Care Pediatrics
      • Saint George, Utah, United States, 84790
        • Dixie Pediatrics
      • Syracuse, Utah, United States, 84075
        • Wee Care Pediatrics
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Research of Charlottesville, LLC
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Associates of Charlottesville, PLC
    • Washington
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From Dose 1 to 6 months following 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Time Frame: 1 month after Dose 3
Pneumococcal IgG antibody against each of 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) was measured using direct binding 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 were set to 0.5*LLOQ.GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5*LLOQ.GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).
1 month after Dose 3
Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Time Frame: 1 month after Dose 4
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 4
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Time Frame: 1 month after Dose 3
OPA titers 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 randomized subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs 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. OPA titers were determined in randomized subsets of participants at 1 month after Dose 3.
1 month after Dose 3
Serotype-specific OPA GMTs at 1 Month After Dose 4
Time Frame: 1 month after Dose 4
OPA titers 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 randomized subsets of participants at 1 month after Dose 4. Results were expressed as OPA titers. GMTs 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. OPA titers were determined in randomized subsets of participants 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
Time Frame: 1 month after Dose 3 to before Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 were reported from Dose 3 evaluable immunogenicity participant.
1 month after Dose 3 to before Dose 4
Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Time Frame: From 1 month before to 1 month after Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month before Dose 4 to 1 month after Dose 4 were reported from Dose 4 evaluable immunogenicity participants.
From 1 month before to 1 month after Dose 4
Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Time Frame: from 1 month after Dose 3 to 1 month after Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 were reported from participants in both Dose 3 and Dose 4 evaluable immunogenicity populations.
from 1 month after Dose 3 to 1 month after Dose 4
Percentage of Participants With Alternative Prespecified Hib Antibody Level 1 Month After Dose 3
Time Frame: 1 month after Dose 3
Antibody concentration to the Hib vaccine antigens were determined on sera collected from a randomly selected subset of participants with sufficient sera volumes. Percentage of participants with alternative prespecified Hib antibody (≥1.0 μg/mL) were reported from Dose 3 evaluable immunogenicity participants.
1 month after Dose 3
Geometric Mean Ratios (GMRs) of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Measles) 1 Month After Dose 4
Time Frame: 1 month after Dose 4
Antibody concentrations to concomitant vaccine antigen (measles) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs 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 and were reported from Dose 4 evaluable immunogenicity participants.
1 month after Dose 4
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Mumps) 1 Month After Dose 4
Time Frame: 1 month after Dose 4
Antibody concentrations to concomitant vaccine antigen (mumps) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs 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 and were reported from Dose 4 evaluable immunogenicity participants.
1 month after Dose 4
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens (Rubella) 1 Month After Dose 4
Time Frame: 1 month after Dose 4
Antibody concentrations to concomitant vaccine antigen (rubella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs 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 and were reported from Dose 4 evaluable immunogenicity participants.
1 month after Dose 4
GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Varicella) 1 Month After Dose 4
Time Frame: 1 month after Dose 4
Antibody concentrations to concomitant vaccine antigen (varicella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs 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 and were reported from Dose 4 evaluable immunogenicity participants.
1 month after Dose 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2020

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

September 2, 2022

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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