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Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

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: NCT04526574
Recruitment Status : Completed
First Posted : August 26, 2020
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) Other: Saline Biological: Influenza vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1797 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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 (20VPNC) WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS ≥65 YEARS OF AGE
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : June 29, 2021
Actual Study Completion Date : June 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Active Comparator: Coadministration Group
Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.
Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)

Other: Saline
Normal saline for injection

Biological: Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)

Active Comparator: Separate Administration Group
Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)

Other: Saline
Normal saline for injection

Biological: Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)




Primary Outcome Measures :
  1. Percentage of participants reporting prompted local reactions within 10 days after each vaccination [ Time Frame: Day 10 ]
    Prompted local reactions after each vaccination

  2. Percentages of participants reporting prompted systemic events within 7 days after each vaccination in each group [ Time Frame: Day 7 ]
    Prompted systemic events after each vaccination

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

  4. Percentage of participants reporting SAEs from the first vaccination up to 6 months after the last vaccination [ Time Frame: 7 months ]
    SAEs occurring within 6 months after the last vaccination

  5. Percentage of participants reporting any newly diagnosed chronic medical condition (NDCMC) up to 6 months after the last vaccination [ Time Frame: 7 months ]
    NDCMCs occurring within 6 months after the last vaccination

  6. Geometric Mean Ratio (GMR) of the serotype-specific OPA titers 1 month after vaccination with 20vPnC from the coadministration group to the serotype-specific OPA titers 1 month after vaccination with 20vPnC from the separate-administration group [ Time Frame: 1 month after vaccination with 20vPnC ]
    Pneumococcal serotype-specific opsonophagocytic activity (OPA) titers 1 month after 20vPnC

  7. GMR of the strain-specific hemagglutination inhibition assay (HAI) titers 1 month after vaccination with SIIV from the coadministration group to the corresponding strain from the separate-administration group [ Time Frame: 1 month after vaccination with SIIV ]
    Strain-specific HAI titers 1 month after SIIV


Secondary Outcome Measures :
  1. GMFR in serotype-specific OPA titers from before vaccination to 1 month after vaccination [ Time Frame: 1 month after vaccination with 20vPnC ]
    Pneumococcal serotype-specific OPA titers from before to 1 month after 20vPnC

  2. Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination [ Time Frame: 1 month after vaccination with 20vPnC ]
    Pneumococcal serotype-specific OPA titers from before to 1 month after 20vPnC

  3. Four-fold rises of immune responses to SIIV when coadministered with 20vPnC or administered alone [ Time Frame: 1 month after vaccination with SIIV ]
    Strain-specific HAI titers from before to 1 month after SIIV



Information from the National Library of Medicine

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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
  • Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
  • Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
  • Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.

    -- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study

  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results

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): NCT04526574


Locations
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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: NCT04526574    
Other Study ID Numbers: B7471004
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
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
Bacterial Infections and Mycoses
Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs