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Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2

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ClinicalTrials.gov Identifier: NCT04887948
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone

Condition or disease Intervention/treatment Phase
Pneumococcal Disease COVID-19 SARS-CoV-2 Infection Biological: 20-valent pneumococcal conjugate vaccine (20vPnC) Biological: BNT162b2 Other: Saline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Triple
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : November 29, 2021
Estimated Study Completion Date : November 29, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Coadministration Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
 Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)

Biological: BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2)
Active Comparator: 20vPnC-only Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
 Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)

Other: Saline
Normal saline for injection
Active Comparator: BNT162b2-only Group
Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.
 Biological: BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2)

Other: Saline
Normal saline for injection


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants reporting prompted local reactions within 10 days after vaccination [ Time Frame: 10 days ]
    Prompted local reactions (redness, swelling, pain) after vaccination

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

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

  4. Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination [ Time Frame: 6 months ]
    SAEs occurring within 6 months after vaccination


Secondary Outcome Measures :
  1. Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) in participants vaccinated with 20vPnC [ Time Frame: 1 month after vaccination with 20vPnC ]
    Pneumococcal OPA GMTs 1 month after 20vPnC

  2. Geometric mean concentration (GMC) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with BNT162b2 [ Time Frame: 1 month after vaccination with BNT162b2 ]
    SARS-CoV-2 full-length S-binding antibody levels 1 month after BNT162b2

  3. Geometric mean fold-rise (GMFR) in SARS-CoV-2 full-length S-binding antibody levels from before vaccination to 1 month after vaccination in participants vaccinated with BNT162b2 [ Time Frame: 1 month after vaccination with BNT162b2 ]
    GMFR in SARS-CoV-2 full-length S-binding antibody levels from before to 1 month after BNT162b2


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female participants ≥65 years of age at the time of consent
  • Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2 with the second dose given ≥6 months prior to the first vaccination in this study, and have not received a third dose of BNT162b2
  • Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease
  • Adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this study

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
  • Previous clinical or microbiological diagnosis of COVID-19
  • Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
  • Previous vaccination with any coronavirus vaccine, other than those received in Study C4591001
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
Contacts and Locations
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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): NCT04887948


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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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04887948    
Other Study ID Numbers: B7471026
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
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
 Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs