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

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ClinicalTrials.gov Identifier: NCT03313037
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Multivalent Biological: Prevnar 13 Biological: PPSV23 Other: Saline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : December 10, 2018
Estimated Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multivalent
Pneumococcal conjugate vaccine
Biological: Multivalent
Pneumococcal conjugate vaccine

Other: Saline
Placebo

Active Comparator: Control
Prevnar 13 and PPSV23
Biological: Prevnar 13
Pneumococcal conjugate vaccine

Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23




Primary Outcome Measures :
  1. Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness, swelling, and pain at the injection site). [ Time Frame: Day 10 ]
    Describe prompted local reactions after Vaccination 1.

  2. Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). [ Time Frame: Day 7 ]
    Describe prompted systemic events after Vaccination 1.

  3. Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination. [ Time Frame: Month 1 after Vaccination 1 ]
    Describe adverse events occurring within 1 month after Vaccination 1.

  4. Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months and 12 months after vaccination. [ Time Frame: Month 6 and Month 12 after Vaccination 1 ]
    Describe SAEs and NDCMCs occurring 6 months and 12 months after Vaccination 1.


Secondary Outcome Measures :
  1. Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after vaccination. [ Time Frame: Month 1 after Vaccination 1 ]
    Describe OPA GMTs 1 month after vaccination.

  2. Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) from before vaccination to 1 month after vaccination. [ Time Frame: Month 1 after Vaccination 1 ]
    Describe OPA GMFRs before vaccination to 1 month after vaccination.



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Ages Eligible for Study:   60 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313037


Locations
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
QPS-MRA, LLC (Miami Research Associates)
South Miami, Florida, United States, 33143
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Medical Research South, LLC
Charleston, South Carolina, United States, 29407
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States, 84020
J. Lewis Research, Inc. - Jordan River Family Medicine
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03313037     History of Changes
Other Study ID Numbers: B7471002
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs