A Study to Learn About How a New Pneumococcal Vaccine Works in Adults

NCT07086677
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
380
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Lead sponsor
Pfizer
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Start date
2025-07-22
clinicaltrials.gov
Number of sites
20
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Summary
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: * an experimental PG4 vaccine * a PG4 vaccine comparator * a standard 20vPnC vaccine comparator * placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.
clinicaltrials.gov
Short title
A Study to Learn About How a New Pneumococcal Vaccine Works in Adults
clinicaltrials.gov
Official title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-10-21
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First posted
2025-07-25
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Registry last updated
2026-06-22
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Primary completion date
2027-10-21
clinicaltrials.gov
Start date
2025-07-22
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Actual participants
380
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Participants
380
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
20
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07086677
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ClinicalTrials.gov ID
NCT07086677
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percentage of participants reporting prespecified local reactions after each dose.

    Timeframe: Within 7 days after each study intervention.

    Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.

  2. Percentage of participants reporting prespecified systemic reactions after each dose.

    Timeframe: Within 7 days after each study intervention.

    Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.

  3. Percentage of participants reporting adverse events.

    Timeframe: From signing of the ICD to 1 month after last study intervention.

    Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination

  4. Percentage of participants reporting serious adverse events.

    Timeframe: From signing of the ICD to 6 months after the last study intervention.

    Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.

  5. Percentage of participants reporting serious adverse events.

    Timeframe: From signing of the ICD to 12 months after the last study intervention.

    Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination.

  6. Percentage of participants with abnormal hematology and chemistry laboratory values.

    Timeframe: Within 2 weeks after each study intervention.

    Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Older adults
Minimum age
65 Years
Maximum age
84 Years
Healthy volunteers
Yes

Key Inclusion Criteria:

  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Participants either with no history of ever receiving a pneumococcal vaccine or who have received a pneumococcal vaccine more than 5 years prior to vaccination in this study

Key Exclusion Criteria:

• Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.

Sources for eligibility
clinicaltrials.gov

  • Orange County Research CenterLake Forest, United States
  • Peninsula Research AssociatesRolling Hills Estates, United States
  • Finlay Medical ResearchGreenacres City, United States
  • Indago Research & Health Center, Inc.Miami Lakes, United States
  • Johnson County Clinical TrialsLenexa, United States
  • Bio-Kinetic Clinical Applications, LLC dba QPS-MOSpringfield, United States
  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment CenterSpringfield, United States
  • Bio-Kinetic Clinical Applications, LLC dba QPS-MOSpringfield, United States
  • Velocity Clinical Research, OmahaOmaha, United States
  • Upstate Global Health InstituteEast Syracuse, United States
  • NYU Langone Health Vaccine CenterNew York, United States
  • Duke Vaccine and Trials UnitDurham, United States
  • CTI Clinical Research CenterCincinnati, United States
  • Headlands Horizons, LLC dba Headlands Research-BrownsvilleBrownsville, United States
  • Valley Regional Medical CenterBrownsville, United States
  • LabCorpHouston, United States
  • IMA Clinical Research San AntonioSan Antonio, United States
  • Dynamed Clinical Research, LP d/b/a DM Clinical ResearchTomball, United States
  • J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake City, United States
  • J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake City, United States
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Targets (3)