Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age

A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 60 THROUGH 64 YEARS OF AGE

This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Other: Saline; Biological: PPSV23; Biological: Multivalent; Biological: Prevnar 13

• Study Type: Interventional
• Enrollment (Actual): 444
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Medical Research South, LLC
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
  • Utah
    • Draper, Utah, United States, 84020
      • J. Lewis Research Inc. / Foothill Family Clinic Draper
    • South Jordan, Utah, United States, 84095
      • J. Lewis Research, Inc. - Jordan River Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female adults >/= 60 to </=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
2. Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
3. Female subjects who are not of childbearing potential.

Exclusion Criteria:

1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
2. History of microbiologically proven invasive disease caused by S pneumoniae.
3. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multivalent; Pneumococcal conjugate vaccine	Other: Saline; Placebo; Biological: Multivalent; Pneumococcal conjugate vaccine
Active Comparator: Control; Prevnar 13 and PPSV23	Biological: PPSV23; Pneumococcal polysaccharide vaccine; Other Names: Pneumovax 23; Biological: Prevnar 13; Pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1	Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.	within 10 days after Vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1	Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=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. Fatigue, headache, muscle pain and joint pain were graded as mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.	within 7 days after Vaccination 1
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	within 1 month after Vaccination 1 (up to 35 days)
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.	within 6 months after Vaccination 1 (up to 196 days)
Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.	within 12 months after Vaccination 1 (up to 378 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC	Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis.	1 month after Vaccination 1
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC	Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.	1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC	GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.	before Vaccination 1 to one month after Vaccination 1
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC	GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.	before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Hurley D, Griffin C, Young M, Scott DA, Pride MW, Scully IL, Ginis J, Severs J, Jansen KU, Gruber WC, Watson W. Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age. Clin Infect Dis. 2021 Oct 5;73(7):e1489-e1497. doi: 10.1093/cid/ciaa1045.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B7471002

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