En studie för att lära sig om säkerheten och immunsvaret för ett nytt pneumokockvaccin hos vuxna
En fas 1/2, randomiserad, dubbelblind studie av säkerheten och immunogeniciteten hos ett multivalent pneumokockkonjugatvaccin hos vuxna 18 år och äldre
The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.
This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle.
Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided.
Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle.
Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle.
Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle.
Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Biologisk: Multivalent Pneumococcal Vaccine - Formulation 3
- Biologisk: Multivalent Pneumococcal Vaccine - Formulation 1
- Biologisk: 20-valent pneumococcal conjugate vaccine (20vPnC)
- Biologisk: Multivalent Pneumococcal Vaccine - Formulation 2
- Biologisk: Licensed pneumococcal comparator vaccine
- Biologisk: Multivalent Pneumococcal Vaccine - Formulation 4
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
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Florida
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Doral, Florida, Förenta staterna, 33172
- Alliance for Multispecialty Research, LLC
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Hialeah, Florida, Förenta staterna, 33012
- Indago Research & Health Center, Inc
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Georgia
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Stockbridge, Georgia, Förenta staterna, 30281
- Clinical Research Atlanta
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Illinois
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Peoria, Illinois, Förenta staterna, 61614
- Optimal Research
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70119
- Alliance for Multispecialty Research, LLC
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Michigan
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Southfield, Michigan, Förenta staterna, 48034
- Headlands Research - Detroit
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New York
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Rochester, New York, Förenta staterna, 14609
- Rochester Clinical Research, LLC
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Tarrytown, New York, Förenta staterna, 10591
- IMA Evaluations, LLC dba IMA Clinical Research
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North Carolina
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Wilmington, North Carolina, Förenta staterna, 28401
- Accellacare - Wilmington
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37909
- AMR Clinical
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Knoxville, Tennessee, Förenta staterna, 37920
- AMR Clinical
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Texas
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Brownsville, Texas, Förenta staterna, 78526
- Headlands Horizons LLC
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Houston, Texas, Förenta staterna, 77065
- DM Clinical Research- Cyfair
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San Antonio, Texas, Förenta staterna, 78229
- IMA Clinical Research San Antonio
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San Antonio, Texas, Förenta staterna, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Sugarland, Texas, Förenta staterna, 77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball, Texas, Förenta staterna, 77375
- DM Clinical Research
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Tomball, Texas, Förenta staterna, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, Förenta staterna, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Förenta staterna, 84109
- J. Lewis Research, Inc.
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Male or female participants ≥18 to<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent
- Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
- Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
- Phase 1 (Stage 1): Adults 18 through 49 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve)
- Phase 2 (Stages 2, 3, and 4): Adults ≥50 through 64 years of age with no history of ever receiving a pneumococcal vaccine (ie, pneumococcal vaccine-naïve) and adults 65 years of age and older with either no history of ever receiving a pneumococcal vaccine or who received PPSV23 >5 years prior to the first vaccination in this study (ie, experienced)
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
- Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
- Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
- Known or suspected immunodeficiency or other conditions associated with immunosuppression
- Planned receipt of any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
- Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3. |
Multivalent pneumococcal conjugate vaccine |
|
Experimentell: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
|
Aktiv komparator: Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC)
Participants to receive a single injection of 20vPnC. |
20-valent pneumococcal conjugate vaccine (20vPnC)
Andra namn:
|
|
Experimentell: Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
|
Aktiv komparator: Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine
Participants to receive a single injection of a licensed pneumococcal comparator vaccine. |
A licensed pneumococcal comparator vaccine |
|
Experimentell: Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4
Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4. |
Multivalent pneumococcal conjugate vaccine |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Tidsram: 7 days
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Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination |
7 days
|
|
Percentage of participants reporting prespecified systemic events within 7 days after vaccination
Tidsram: 7 days
|
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination |
7 days
|
|
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Tidsram: 1 month
|
Adverse events occurring within 1 month after vaccination |
1 month
|
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Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
Tidsram: 6 months
|
SAEs occurring within 6 months after vaccination |
6 months
|
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Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
Tidsram: 12 months
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Related SAEs occurring through 12 months after vaccination |
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Tidsram: 1 month after vaccination
|
Pneumococcal OPA GMTs 1 month after vaccination |
1 month after vaccination
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C4931001
- NCT06182124 (Registeridentifierare: ClinicalTrials.gov)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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