Une étude pour en savoir plus sur l'innocuité et la réponse immunitaire d'un nouveau vaccin antipneumococcique chez les adultes
Un essai de phase 1/2, randomisé et en double aveugle sur l'innocuité et l'immunogénicité d'un vaccin conjugué multivalent contre le pneumocoque chez les adultes de 18 ans et plus
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Biologique: Multivalent Pneumococcal Vaccine - Formulation 3
- Biologique: Multivalent Pneumococcal Vaccine - Formulation 1
- Biologique: 20-valent pneumococcal conjugate vaccine (20vPnC)
- Biologique: Multivalent Pneumococcal Vaccine - Formulation 2
- Biologique: Licensed pneumococcal comparator vaccine
- Biologique: Multivalent Pneumococcal Vaccine - Formulation 4
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Florida
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Doral, Florida, États-Unis, 33172
- Alliance for Multispecialty Research, LLC
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Hialeah, Florida, États-Unis, 33012
- Indago Research & Health Center, Inc
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Georgia
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Stockbridge, Georgia, États-Unis, 30281
- Clinical Research Atlanta
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Illinois
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Peoria, Illinois, États-Unis, 61614
- Optimal Research
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Louisiana
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New Orleans, Louisiana, États-Unis, 70119
- Alliance for Multispecialty Research, LLC
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Michigan
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Southfield, Michigan, États-Unis, 48034
- Headlands Research - Detroit
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New York
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Rochester, New York, États-Unis, 14609
- Rochester Clinical Research, LLC
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Tarrytown, New York, États-Unis, 10591
- IMA Evaluations, LLC dba IMA Clinical Research
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North Carolina
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Wilmington, North Carolina, États-Unis, 28401
- Accellacare - Wilmington
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Tennessee
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Knoxville, Tennessee, États-Unis, 37909
- AMR Clinical
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Knoxville, Tennessee, États-Unis, 37920
- AMR Clinical
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Texas
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Brownsville, Texas, États-Unis, 78526
- Headlands Horizons LLC
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Houston, Texas, États-Unis, 77065
- DM Clinical Research- Cyfair
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San Antonio, Texas, États-Unis, 78229
- IMA Clinical Research San Antonio
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San Antonio, Texas, États-Unis, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Sugarland, Texas, États-Unis, 77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball, Texas, États-Unis, 77375
- DM Clinical Research
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Tomball, Texas, États-Unis, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, États-Unis, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, États-Unis, 84109
- J. Lewis Research, Inc.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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). |
|
Comparateur actif: 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)
Autres noms:
|
|
Expérimental: 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). |
|
Comparateur actif: 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 |
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 12 months
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Related SAEs occurring through 12 months after vaccination |
12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Délai: 1 month after vaccination
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Pneumococcal OPA GMTs 1 month after vaccination |
1 month after vaccination
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- C4931001
- NCT06182124 (Identificateur de registre: ClinicalTrials.gov)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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