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

NCT03760146

Last updated date
Study Location
Accel Resarch Sites
Birmingham, Alabama, 35216, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.

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. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.


4. Pregnant female subjects or breastfeeding female subjects.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
NCT04382326
  1. Paramount, California
  2. Colorado Springs, Colorado
  3. Apopka, Florida
  4. Gainesville, Florida
  5. Gainesville, Florida
  6. Miami, Florida
  7. Miami, Florida
  8. Nampa, Idaho
  9. El Dorado, Kansas
  10. Baton Rouge, Louisiana
  11. Covington, Louisiana
  12. Missoula, Montana
  13. Albuquerque, New Mexico
  14. Dayton, Ohio
  15. Fairfield, Ohio
  16. Erie, Pennsylvania
  17. Charleston, South Carolina
  18. Cheraw, South Carolina
  19. North Charleston, South Carolina
  20. Kaysville, Utah
  21. Layton, Utah
  22. Murray, Utah
  23. Murray, Utah
  24. Roy, Utah
  25. Saint George, Utah
  26. Syracuse, Utah
  27. Charlottesville, Virginia
  28. Charlottesville, Virginia
  29. Charlottesville, Virginia
  30. Guayama,
  31. Dothan, Alabama
  32. Fayetteville, Arkansas
  33. Ontario, California
  34. Homestead, Florida
  35. Chamblee, Georgia
  36. Idaho Falls, Idaho
  37. Idaho Falls, Idaho
  38. Bardstown, Kentucky
  39. Louisville, Kentucky
  40. Haughton, Louisiana
  41. Lincoln, Nebraska
  42. Lincoln, Nebraska
  43. Dayton, Ohio
  44. East Norriton, Pennsylvania
  45. Bristol, Tennessee
  46. Kingsport, Tennessee
  47. Houston, Texas
  48. San Antonio, Texas
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal Disease20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
NCT04379713
  1. Canoga Park, California
  2. Sacramento, California
  3. Miami, Florida
  4. North Miami Beach, Florida
  5. Bridgeton, Missouri
  6. Summerville, South Carolina
  7. Lampasas, Texas
  8. Lampasas, Texas
  9. Pharr, Texas
  10. Layton, Utah
  11. Fort Myers, Florida
  12. Naples, Florida
  13. Blackfoot, Idaho
  14. Statesville, North Carolina
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal DiseaseSerotype Distribution of Chest X-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year.
NCT01564771
  1. Athens, Attiki
  2. Alexandroupoli, Evros
  3. Alexandroupoli,
  4. Athens,
  5. Athens,
  6. Athens,
  7. Athens,
  8. Athens,
  9. Athens,
  10. Athens,
  11. Athens,
  12. Athens,
  13. Athens,
  14. Athens,
  15. Athens,
  16. Athens,
  17. Athens,
  18. Athnens,
  19. Kavala,
  20. Kavala,
  21. Larissa,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pneumococcal DiseaseChild Pneumococcal Serotype Epidemiology In Greece
NCT01111214
  1. Athens, Attiki
  2. Alexandroupoli,
  3. Herakleion,
  4. Herakleion,
  5. Ioannina,
  6. Larissa,
  7. Thessaloniki,
  8. Thessaloniki,
  9. Trikala,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Official Title  ICMJE 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 18 YEARS OF AGE AND OLDER
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE
  • Biological: 20vPnC
    20vPnC
  • Biological: 13vPnC
    Pneumococcal conjugate vaccine
  • Biological: PPSV23
    Pneumococcal polysaccharide vaccine
    Other Name: Pneumovax 23
  • Other: Saline
    Placebo
Study Arms  ICMJE
  • Experimental: 60 years and above 20vPnC/Saline
    20vPnC and saline
    Interventions:
    • Biological: 20vPnC
    • Other: Saline
  • Active Comparator: 60 years and above 13vPnC/PPSV23
    13vPnC and PPSV23
    Interventions:
    • Biological: 13vPnC
    • Biological: PPSV23
  • Experimental: 50 through 59 years of age 20vPnC
    20vPnC
    Intervention: Biological: 20vPnC
  • Experimental: 18 through 49 years of age 20vPnC
    20vPnC
    Intervention: Biological: 20vPnC
  • Active Comparator: 50 through 59 years of age 13vPnC
    13vPnC
    Intervention: Biological: 13vPnC
  • Active Comparator: 18 through 49 years of age 13vPnC
    13vPnC
    Intervention: Biological: 13vPnC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2020)
3902
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2018)
3880
Actual Study Completion Date  ICMJE December 16, 2019
Actual Primary Completion Date December 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
  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. Negative urine pregnancy test at Visit1 for all subjects who are 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.
  4. Pregnant female subjects or breastfeeding female subjects.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03760146
Other Study ID Numbers  ICMJE B7471007
2018-004279-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP