Eine Studie, um mehr über die Sicherheit und Immunantwort eines neuen Pneumokokken-Impfstoffs bei Erwachsenen zu erfahren
Eine randomisierte, doppelblinde Phase-1/2-Studie zur Sicherheit und Immunogenität eines multivalenten Pneumokokken-Konjugat-Impfstoffs bei Erwachsenen ab 18 Jahren
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Biologisch: Multivalent Pneumococcal Vaccine - Formulation 3
- Biologisch: Multivalent Pneumococcal Vaccine - Formulation 1
- Biologisch: 20-valent pneumococcal conjugate vaccine (20vPnC)
- Biologisch: Multivalent Pneumococcal Vaccine - Formulation 2
- Biologisch: Licensed pneumococcal comparator vaccine
- Biologisch: Multivalent Pneumococcal Vaccine - Formulation 4
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
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Florida
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Doral, Florida, Vereinigte Staaten, 33172
- Alliance for Multispecialty Research, LLC
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Hialeah, Florida, Vereinigte Staaten, 33012
- Indago Research & Health Center, Inc
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Georgia
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Stockbridge, Georgia, Vereinigte Staaten, 30281
- Clinical Research Atlanta
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Illinois
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Peoria, Illinois, Vereinigte Staaten, 61614
- Optimal Research
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70119
- Alliance for Multispecialty Research, LLC
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Michigan
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Southfield, Michigan, Vereinigte Staaten, 48034
- Headlands Research - Detroit
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New York
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Rochester, New York, Vereinigte Staaten, 14609
- Rochester Clinical Research, LLC
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Tarrytown, New York, Vereinigte Staaten, 10591
- IMA Evaluations, LLC dba IMA Clinical Research
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North Carolina
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Wilmington, North Carolina, Vereinigte Staaten, 28401
- Accellacare - Wilmington
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37909
- AMR Clinical
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Knoxville, Tennessee, Vereinigte Staaten, 37920
- AMR Clinical
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Texas
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Brownsville, Texas, Vereinigte Staaten, 78526
- Headlands Horizons LLC
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Houston, Texas, Vereinigte Staaten, 77065
- DM Clinical Research- Cyfair
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San Antonio, Texas, Vereinigte Staaten, 78229
- IMA Clinical Research San Antonio
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San Antonio, Texas, Vereinigte Staaten, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Sugarland, Texas, Vereinigte Staaten, 77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball, Texas, Vereinigte Staaten, 77375
- DM Clinical Research
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Tomball, Texas, Vereinigte Staaten, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Vereinigte Staaten, 84109
- J. Lewis Research, Inc.
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 |
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Experimental: 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). |
|
Aktiver 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)
Andere Namen:
|
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Experimental: 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). |
|
Aktiver 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 |
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Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Zeitfenster: 7 days
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Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination |
7 days
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Percentage of participants reporting prespecified systemic events within 7 days after vaccination
Zeitfenster: 7 days
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Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination |
7 days
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Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Zeitfenster: 1 month
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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
Zeitfenster: 6 months
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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
Zeitfenster: 12 months
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Related SAEs occurring through 12 months after vaccination |
12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Zeitfenster: 1 month after vaccination
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Pneumococcal OPA GMTs 1 month after vaccination |
1 month after vaccination
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C4931001
- NCT06182124 (Registrierungskennung: ClinicalTrials.gov)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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