Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE
1 other identifier
interventional
1,710
1 country
21
Brief Summary
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2019
Shorter than P25 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
February 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2019
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedNovember 23, 2020
November 1, 2020
8 months
February 1, 2019
September 21, 2020
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Within 10 days after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Within 7 days after vaccination
Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Within 1 month after vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Within 6 month after vaccination
Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 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. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Within 6 months after vaccination
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
1 month after vaccination
Secondary Outcomes (3)
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Before vaccination to 1 month after vaccination
Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Before vaccination to 1 month after vaccination
Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
1 month after vaccination
Study Arms (4)
20vPnC Lot 1
EXPERIMENTAL20vPnC Lot 1
20vPnC Lot 2
EXPERIMENTAL20vPnC Lot 2
20vPnC Lot 3
EXPERIMENTAL20vPnC Lot 3
13vPnC
ACTIVE COMPARATOR13vPnC
Interventions
Eligibility Criteria
You may qualify if:
- Male or female adults ≥18 and \<50 years of age.
- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
- Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.
You may not qualify if:
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Pregnant female subjects or breastfeeding female subjects (known or suspected).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (21)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Kaiser Permanente Sacramento
Sacramento, California, 95815, United States
Kaiser Permanente South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente San Jose
San Jose, California, 95119, United States
Kaiser Permanente Santa Clara
Santa Clara, California, 95051, United States
Accel Research Sites - Clinical Research Unit
DeLand, Florida, 32720, United States
Research Centers of America, LLC
Hollywood, Florida, 33024, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
East West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, 57049, United States
Benchmark Research
Austin, Texas, 78705, United States
J. Lewis Research, Inc. /Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. /Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Related Publications (2)
Sabharwal C, Sundaraiyer V, Peng Y, Moyer L, Belanger TJ, Gessner BD, Jodar L, Jansen KU, Gruber WC, Scott DA, Watson W. Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease. Hum Vaccin Immunother. 2022 Nov 30;18(6):2126253. doi: 10.1080/21645515.2022.2126253. Epub 2022 Nov 11.
PMID: 36368038DERIVEDKlein NP, Peyrani P, Yacisin K, Caldwell N, Xu X, Scully IL, Scott DA, Jansen KU, Gruber WC, Watson W. A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. Vaccine. 2021 Sep 7;39(38):5428-5435. doi: 10.1016/j.vaccine.2021.07.004. Epub 2021 Jul 24.
PMID: 34315611DERIVED
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2019
First Posted
February 4, 2019
Study Start
February 14, 2019
Primary Completion
October 9, 2019
Study Completion
October 9, 2019
Last Updated
November 23, 2020
Results First Posted
November 4, 2020
Record last verified: 2020-11
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.