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Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

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ClinicalTrials.gov Identifier: NCT03828617
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 20vPnC Biological: 13vPnC Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : December 16, 2019
Estimated Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 20vPnC Lot 1
20vPnC Lot 1
Biological: 20vPnC
20vPnC

Experimental: 20vPnC Lot 2
20vPnC Lot 2
Biological: 20vPnC
20vPnC

Experimental: 20vPnC Lot 3
20vPnC Lot 3
Biological: 20vPnC
20vPnC

Active Comparator: 13vPnC
13vPnC
Biological: 13vPnC
Pneumococcal conjugate vaccine




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

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

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

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

  5. Serotype-specific OPA titers 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    OPA titers 1 month after vaccination.


Secondary Outcome Measures :
  1. Fold rise in serotype-specific OPA titers from before to 1 month after vaccination. [ Time Frame: From before to 1 month after vaccination ]
    Fold rise in OPA titers 1 month after vaccination.

  2. ≥4-Fold rise in serotype-specific OPA titers from before to 1 month after vaccination. [ Time Frame: From before to 1 month after vaccination ]
    Subjects with ≥4-fold rise in OPA titers 1 month after vaccination.

  3. Serotype-specific OPA titers greater than or equal to the lower limit of quantitation (≥ LLOQ) 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    Subjects with OPA titers ≥ LLOQ 1 month after vaccination.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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): NCT03828617


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Kaiser Permanente Vaccine Study Center Not yet recruiting
Oakland, California, United States, 94612
Kaiser Permanente Sacramento Recruiting
Sacramento, California, United States, 95815
Kaiser Permanente South Sacramento Not yet recruiting
Sacramento, California, United States, 95823
Kaiser Permanente San Jose Recruiting
San Jose, California, United States, 95119
Kaiser Permanente Santa Clara Recruiting
Santa Clara, California, United States, 95051
United States, Florida
Research Centers of America, LLC Not yet recruiting
Hollywood, Florida, United States, 33024
United States, Georgia
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East West Medical Research Institute Not yet recruiting
Honolulu, Hawaii, United States, 96814
United States, Kentucky
Kentucky Pediatric/Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
United States, Nebraska
Meridian Clinical Research, LLC Recruiting
Norfolk, Nebraska, United States, 68701
Meridian Clinical Research, LLC Recruiting
Omaha, Nebraska, United States, 68134
United States, North Carolina
M3 Wake Research, Inc. Recruiting
Raleigh, North Carolina, United States, 27612
United States, Rhode Island
Omega Medical Research Not yet recruiting
Warwick, Rhode Island, United States, 02886
United States, South Dakota
Meridian Clinical Research Recruiting
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Benchmark Research Not yet recruiting
Austin, Texas, United States, 78705
United States, Utah
J. Lewis Research, Inc. /Foothill Family Clinic Recruiting
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. /Foothill Family Clinic Recruiting
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03828617     History of Changes
Other Study ID Numbers: B7471008
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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

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