En undersøgelse for at lære om sikkerheden og immunresponsen af en ny pneumokokvaccine hos voksne
En fase 1/2, randomiseret, dobbeltblind undersøgelse af sikkerheden og immunogeniciteten af en multivalent pneumokokkonjugatvaccine hos voksne 18 år og ældre
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.
Studieoversigt
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Doral, Florida, Forenede Stater, 33172
- Alliance for Multispecialty Research, LLC
-
Hialeah, Florida, Forenede Stater, 33012
- Indago Research & Health Center, Inc
-
-
Georgia
-
Stockbridge, Georgia, Forenede Stater, 30281
- Clinical Research Atlanta
-
-
Illinois
-
Peoria, Illinois, Forenede Stater, 61614
- Optimal Research
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70119
- Alliance for Multispecialty Research, LLC
-
-
Michigan
-
Southfield, Michigan, Forenede Stater, 48034
- Headlands Research - Detroit
-
-
New York
-
Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research, LLC
-
Tarrytown, New York, Forenede Stater, 10591
- IMA Evaluations, LLC dba IMA Clinical Research
-
-
North Carolina
-
Wilmington, North Carolina, Forenede Stater, 28401
- Accellacare - Wilmington
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37909
- AMR Clinical
-
Knoxville, Tennessee, Forenede Stater, 37920
- AMR Clinical
-
-
Texas
-
Brownsville, Texas, Forenede Stater, 78526
- Headlands Horizons LLC
-
Houston, Texas, Forenede Stater, 77065
- DM Clinical Research- Cyfair
-
San Antonio, Texas, Forenede Stater, 78229
- IMA Clinical Research San Antonio
-
San Antonio, Texas, Forenede Stater, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
-
Sugarland, Texas, Forenede Stater, 77478
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
Tomball, Texas, Forenede Stater, 77375
- DM Clinical Research
-
Tomball, Texas, Forenede Stater, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Salt Lake City, Utah, Forenede Stater, 84109
- J. Lewis Research, Inc.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
|
Eksperimentel: 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 navne:
|
|
Eksperimentel: 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 |
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C4931001
- NCT06182124 (Registry Identifier: ClinicalTrials.gov)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .