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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04887948
Collaborator
(none)
570
Enrollment
29
Locations
3
Arms
6.6
Actual Duration (Months)
19.7
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
  • Biological: BNT162b2
  • Other: Saline
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
570 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
Actual Primary Completion Date :
Dec 8, 2021
Actual Study Completion Date :
Dec 8, 2021

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Percentage of participants reporting prompted local reactions within 10 days after vaccination [10 days]

    Prompted local reactions (redness, swelling, pain) after vaccination

  2. Percentage of participants reporting prompted systemic events within 7 days after vaccination [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 [1 month]

    Adverse events occurring within 1 month after vaccination

  4. Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination [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 [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 [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 [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

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

SiteCityStateCountryPostal Code
1Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
2Diablo Clinical Research, Inc.Walnut CreekCaliforniaUnited States94598
3Alliance for Multispecialty Research, LLCCoral GablesFloridaUnited States33134
4Indago Research & Health Center, Inc.HialeahFloridaUnited States33012
5Indago Research & Health Center, IncHialeahFloridaUnited States33012
6Research Centers of America ( Hollywood )HollywoodFloridaUnited States33024
7Acevedo Clinical Research AssociatesMiamiFloridaUnited States33142
8Clinical Neuroscience SolutionsOrlandoFloridaUnited States32801
9Clinical Research AtlantaStockbridgeGeorgiaUnited States30281
10East-West Medical Research InstituteHonoluluHawaiiUnited States96814
11Solaris Clinical ResearchMeridianIdahoUnited States83646
12Alliance for Multispecialty Research, LLCNewtonKansasUnited States67114
13Clinical Research ProfessionalsChesterfieldMissouriUnited States63005
14Sundance Clinical ResearchSaint LouisMissouriUnited States63141
15Meridian Clinical Research, LLCOmahaNebraskaUnited States68134
16Meridian Clinical Research, LLCEndwellNew YorkUnited States13760
17Accellacare - WilmingtonWilmingtonNorth CarolinaUnited States28401
18Aventiv Research IncColumbusOhioUnited States43213
19Alliance for Multispecialty Research, LLCKnoxvilleTennesseeUnited States37909
20Clinical Neuroscience Solutions, Inc. dba CNS HealthcareMemphisTennesseeUnited States38119
21Clinical Neuroscience Solutions, IncMemphisTennesseeUnited States38119
22Benchmark ResearchAustinTexasUnited States78705
23Diagnostics Research GroupSan AntonioTexasUnited States78229
24DM Clinical ResearchTomballTexasUnited States77375
25Martin Diagnostic ClinicTomballTexasUnited States77375
26Martins Diagnostic ClinicTomballTexasUnited States77375
27J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake CityUtahUnited States84109
28J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake CityUtahUnited States84121
29Wenatchee Valley HospitalWenatcheeWashingtonUnited States98801

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04887948
Other Study ID Numbers:
  • B7471026
First Posted:
May 14, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022