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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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828617
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : March 25, 2020
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)
Actual Enrollment : 1718 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
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 9, 2019

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.



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.


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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


Locations
Show Show 21 study locations
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    
Other Study ID Numbers: B7471008
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
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