En studie for å lære om sikkerheten og immunresponsen til en ny pneumokokkvaksine hos voksne
En fase 1/2, randomisert, dobbeltblind studie av sikkerheten og immunogenisiteten til en multivalent pneumokokkkonjugatvaksine hos voksne 18 år og eldre
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.
Studieoversikt
Status
Forhold
Intervensjon / 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
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Doral, Florida, Forente stater, 33172
- Alliance for Multispecialty Research, LLC
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Hialeah, Florida, Forente stater, 33012
- Indago Research & Health Center, Inc
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Georgia
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Stockbridge, Georgia, Forente stater, 30281
- Clinical Research Atlanta
-
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Illinois
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Peoria, Illinois, Forente stater, 61614
- Optimal Research
-
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Louisiana
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New Orleans, Louisiana, Forente stater, 70119
- Alliance for Multispecialty Research, LLC
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-
Michigan
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Southfield, Michigan, Forente stater, 48034
- Headlands Research - Detroit
-
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New York
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Rochester, New York, Forente stater, 14609
- Rochester Clinical Research, LLC
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Tarrytown, New York, Forente stater, 10591
- IMA Evaluations, LLC dba IMA Clinical Research
-
-
North Carolina
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Wilmington, North Carolina, Forente stater, 28401
- Accellacare - Wilmington
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-
Tennessee
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Knoxville, Tennessee, Forente stater, 37909
- AMR Clinical
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Knoxville, Tennessee, Forente stater, 37920
- AMR Clinical
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Texas
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Brownsville, Texas, Forente stater, 78526
- Headlands Horizons LLC
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Houston, Texas, Forente stater, 77065
- DM Clinical Research- Cyfair
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San Antonio, Texas, Forente stater, 78229
- IMA Clinical Research San Antonio
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San Antonio, Texas, Forente stater, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
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Sugarland, Texas, Forente stater, 77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Tomball, Texas, Forente stater, 77375
- DM Clinical Research
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Tomball, Texas, Forente stater, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, Forente stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Forente stater, 84109
- J. Lewis Research, Inc.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Eksperimentell: 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)
Andre navn:
|
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants reporting prespecified local reactions within 7 days after vaccination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 month
|
Adverse events occurring within 1 month after vaccination |
1 month
|
|
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
Tidsramme: 6 months
|
SAEs occurring within 6 months after vaccination |
6 months
|
|
Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination
Tidsramme: 12 months
|
Related SAEs occurring through 12 months after vaccination |
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs)
Tidsramme: 1 month after vaccination
|
Pneumococcal OPA GMTs 1 month after vaccination |
1 month after vaccination
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C4931001
- NCT06182124 (Registeridentifikator: ClinicalTrials.gov)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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