Clinical trial NCT03828617: Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-02-04
Enrollment: 1710
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female adults ≥18 and \<50 years of age.
2. 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.
3. 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.

Exclusion Criteria:

1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
2. 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.
3. History of microbiologically proven invasive disease caused by S pneumoniae.
4. Pregnant female subjects or breastfeeding female subjects (known or suspected).

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 10 Days After Vaccination
timeFrame: Within 10 days after vaccination
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 month after vaccination
measure: Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination
timeFrame: Within 6 month after vaccination
measure: Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
timeFrame: Within 6 months after vaccination
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
timeFrame: Before vaccination to 1 month after vaccination
measure: 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
timeFrame: Before vaccination to 1 month after vaccination
measure: 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
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: DeLand
country: United States
facility: Accel Research Sites - Clinical Research Unit
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research, LLC
state: South Dakota
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. /Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. /Foothill Family Clinic South
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Klein 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.