Uno studio per conoscere la sicurezza e la risposta immunitaria di un nuovo vaccino pneumococcico negli adulti
Uno studio di fase 1/2, randomizzato, in doppio cieco sulla sicurezza e l'immunogenicità di un vaccino pneumococcico coniugato multivalente negli adulti di età pari o superiore a 18 anni
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
- Biologico: Multivalent Pneumococcal Vaccine - Formulation 3
- Biologico: Multivalent Pneumococcal Vaccine - Formulation 1
- Biologico: 20-valent pneumococcal conjugate vaccine (20vPnC)
- Biologico: Multivalent Pneumococcal Vaccine - Formulation 2
- Biologico: Licensed pneumococcal comparator vaccine
- Biologico: Multivalent Pneumococcal Vaccine - Formulation 4
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Florida
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Doral, Florida, Stati Uniti, 33172
- Alliance for Multispecialty Research, LLC
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Hialeah, Florida, Stati Uniti, 33012
- Indago Research & Health Center, Inc
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Georgia
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Stockbridge, Georgia, Stati Uniti, 30281
- Clinical Research Atlanta
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Illinois
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Peoria, Illinois, Stati Uniti, 61614
- Optimal Research
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70119
- Alliance for Multispecialty Research, LLC
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Michigan
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Southfield, Michigan, Stati Uniti, 48034
- Headlands Research - Detroit
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New York
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Rochester, New York, Stati Uniti, 14609
- Rochester Clinical Research, LLC
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Tarrytown, New York, Stati Uniti, 10591
- IMA Evaluations, LLC dba IMA Clinical Research
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North Carolina
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Wilmington, North Carolina, Stati Uniti, 28401
- Accellacare - Wilmington
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37909
- AMR Clinical
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Knoxville, Tennessee, Stati Uniti, 37920
- AMR Clinical
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Texas
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Brownsville, Texas, Stati Uniti, 78526
- Headlands Horizons LLC
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Houston, Texas, Stati Uniti, 77065
- DM Clinical Research- Cyfair
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San Antonio, Texas, Stati Uniti, 78229
- IMA Clinical Research San Antonio
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San Antonio, Texas, Stati Uniti, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Sugarland, Texas, Stati Uniti, 77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball, Texas, Stati Uniti, 77375
- DM Clinical Research
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Tomball, Texas, Stati Uniti, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, Stati Uniti, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Stati Uniti, 84109
- J. Lewis Research, Inc.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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). |
|
Comparatore attivo: 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)
Altri nomi:
|
|
Sperimentale: 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). |
|
Comparatore attivo: 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 |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Lasso di tempo: 7 days
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
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Related SAEs occurring through 12 months after vaccination |
12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Lasso di tempo: 1 month after vaccination
|
Pneumococcal OPA GMTs 1 month after vaccination |
1 month after vaccination
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C4931001
- NCT06182124 (Identificatore di registro: ClinicalTrials.gov)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .