Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    B7471007
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03760146
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 20vPnC Biological: 13vPnC Biological: PPSV23 Other: Saline Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3880 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 A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : January 2, 2020
Estimated Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 60 years and above 20vPnC/Saline
20vPnC and saline
Biological: 20vPnC
20vPnC

Other: Saline
Placebo

Active Comparator: 60 years and above 13vPnC/PPSV23
13vPnC and PPSV23
Biological: 13vPnC
Pneumococcal conjugate vaccine

Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23

Experimental: 50 through 59 years of age 20vPnC
20vPnC
Biological: 20vPnC
20vPnC

Experimental: 18 through 49 years of age 20vPnC
20vPnC
Biological: 20vPnC
20vPnC

Active Comparator: 50 through 59 years of age 13vPnC
13vPnC
Biological: 13vPnC
Pneumococcal conjugate vaccine

Active Comparator: 18 through 49 years of age 13vPnC
13vPnC
Biological: 13vPnC
Pneumococcal conjugate vaccine




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 ]
    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 ]
    Prompted systemic events after Vaccination 1.

  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/Vaccination 1. [ Time Frame: 6 months after vaccination/Vaccination 1 ]
    SAEs and NDCMCs occurring 6 months after vaccine/Vaccination 1.

  5. Serotype-specific OPA geometric mean titers (GMTs) in 60 year olds and above 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    OPA GMTs 1 month after vaccination.


Secondary Outcome Measures :
  1. Serotype-specific OPA GMTs in 50 through 59 year olds 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    OPA GMTs 1 month after vaccination.

  2. Serotype-specific OPA GMTs in 18 through 49 year olds 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    OPA GMTs 1 month after vaccination.

  3. 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.

  4. ≥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.

  5. 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 greater than or equal to LLOQ 1 month after vaccination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03760146


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 62 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03760146     History of Changes
Other Study ID Numbers: B7471007
2018-004279-11 ( EudraCT Number )
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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