Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

NCT03760146 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: B74710072018-004279-11
• Study Type: interventional
• Target: 3,902
• Locations: 2 countries
• Sites: 68

Brief Summary

A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts

  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).

  Within 10 days after 20vPnC or 13vPnC

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts

  Systemic events fever, fatigue, headache, muscle pain and 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).

  Within 7 days after 20vPnC or 13vPnC

• Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts

  An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

  Within 1 month after 20vPnC or 13vPnC

• Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts

  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.

  Within 6 months after 20vPnC or 13vPnC

• Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts

  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.

  Within 6 months after 20vPnC or 13vPnC

• Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population

  OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

  1 month after Vaccination 1

• Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)

  OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

  1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

Secondary Outcomes (11)

• Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population

  1 month after vaccination

• Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population

  1 month after vaccination

• Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population

  Before Vaccination 1 to 1 month after Vaccination 1

• Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population

  From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"

• Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population

  Before vaccination to 1 month after vaccination

Study Arms (6)

60 years and above 20vPnC/Saline

EXPERIMENTAL

20vPnC and saline

Biological: 20vPnC; Other: Saline

60 years and above 13vPnC/PPSV23

ACTIVE COMPARATOR

13vPnC and PPSV23

Biological: 13vPnC; Biological: PPSV23

50 through 59 years of age 20vPnC

EXPERIMENTAL

20vPnC

Biological: 20vPnC

18 through 49 years of age 20vPnC

EXPERIMENTAL

20vPnC

Biological: 20vPnC

50 through 59 years of age 13vPnC

ACTIVE COMPARATOR

13vPnC

Biological: 13vPnC

18 through 49 years of age 13vPnC

ACTIVE COMPARATOR

13vPnC

Biological: 13vPnC

Interventions

20vPnC BIOLOGICAL

20vPnC

18 through 49 years of age 20vPnC; 50 through 59 years of age 20vPnC; 60 years and above 20vPnC/Saline

13vPnC BIOLOGICAL

Pneumococcal conjugate vaccine

18 through 49 years of age 13vPnC; 50 through 59 years of age 13vPnC; 60 years and above 13vPnC/PPSV23

PPSV23 BIOLOGICAL

Pneumococcal polysaccharide vaccine

Also known as: Pneumovax 23

60 years and above 13vPnC/PPSV23

Saline OTHER

Placebo

60 years and above 20vPnC/Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults \>/= 18 years of age (from the 18th birthday) at enrollment and older.
• 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.
• Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

You may not qualify if:

• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
• History of microbiologically proven invasive disease caused by S pneumoniae.
• 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.
• Pregnant female subjects or breastfeeding female subjects.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (68)

Accel Research Sites

Birmingham, Alabama, 35216, United States

Location

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

East Valley Gastroenterology and Hepatology Associates

Chandler, Arizona, 85224, United States

Location

The Pain Center of Arizona

Peoria, Arizona, 85381, United States

Location

MedPharmics, LLC

Phoenix, Arizona, 85015, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

The Pain Center of Arizona

Phoenix, Arizona, 85018, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Accel Research Sites - Clinical Research Unit

DeLand, Florida, 32720, United States

Location

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Meridian Clinical Research LLC

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Axtell Clinic, P.A.

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Northwest Family Physicians

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Meridian Clinical Research, LLC

Rockville, Maryland, 20854, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research LLC

Omaha, Nebraska, 68134, United States

Location

ActivMed Practices & Research, Inc.

Portsmouth, New Hampshire, 03801, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45246, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Meridian Clinical Research, LLC

Dakota Dunes, South Dakota, 57049, United States

Location

Tekton Research, Inc.

Austin, Texas, 78745, United States

Location

Bellaire Doctor's Clinic

Bellaire, Texas, 77401, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

HealthFirst Medical Group

Fort Worth, Texas, 76135, United States

Location

Ventavia Research Group, LLC

Keller, Texas, 76248, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Ventavia Research Group, LLC

Spring, Texas, 77389, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

J. Lewis Research Inc. / Foothill Family Clinic Draper

Draper, Utah, 84020, 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

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

South Jordan, Utah, 84095, United States

Location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Ladulaas Kliniska Studier

Borås, 50630, Sweden

Location

Infektionskliniken Malarsjukhuset

Eskilstuna, 63188, Sweden

Location

ProbarE i Lund

Lund, 222 22, Sweden

Location

Avdelningen för kliniska prövningar

Örebro, 70362, Sweden

Location

Karolinska Trial Alliance, KTA Prim

Stockholm, 113 61, Sweden

Location

Akardo Med Site

Stockholm, 114 46, Sweden

Location

Akademiska Sjukhuset

Uppsala, 75185, Sweden

Location

Related Publications (4)

• 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: 36368038 DERIVED

• Essink B, Sabharwal C, Cannon K, Frenck R, Lal H, Xu X, Sundaraiyer V, Peng Y, Moyer L, Pride MW, Scully IL, Jansen KU, Gruber WC, Scott DA, Watson W. Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged >/=18 Years. Clin Infect Dis. 2022 Aug 31;75(3):390-398. doi: 10.1093/cid/ciab990.

  PMID: 34940806 DERIVED

• Mt-Isa S, Abderhalden LA, Musey L, Weiss T. Matching-adjusted indirect comparison of pneumococcal vaccines V114 and PCV20. Expert Rev Vaccines. 2022 Jan;21(1):115-123. doi: 10.1080/14760584.2021.1994858. Epub 2021 Oct 27.

  PMID: 34672224 DERIVED

• Perdrizet J, Santana CFS, Senna T, Alexandre RF, Sini de Almeida R, Spinardi J, Wasserman M. Cost-effectiveness analysis of replacing the 10-valent pneumococcal conjugate vaccine (PCV10) with the 13-valent pneumococcal conjugate vaccine (PCV13) in Brazil infants. Hum Vaccin Immunother. 2021 Apr 3;17(4):1162-1172. doi: 10.1080/21645515.2020.1809266. Epub 2020 Sep 23.

  PMID: 32966176 DERIVED

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: December 12, 2018
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: December 2, 2021
• Results First Posted: December 29, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

SE (7); US (61)