A Study of V132 in Healthy Older Participants (V132-001)
31. august 2026 opdateret af: Merck Sharp & Dohme LLC
A Phase 1, Randomized, Double-Blind, Comparator-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V132 in Healthy Older Participants
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
280
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
-
-
California
-
Anaheim, California, Forenede Stater, 92801
- Rekruttering
- Anaheim Clinical Trials ( Site 0006)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 714-774-7777
-
-
Florida
-
Hallandale, Florida, Forenede Stater, 33009
- Rekruttering
- Velocity Clinical Research, Hallandale Beach ( Site 0003)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 954-455-5757
-
Hollywood, Florida, Forenede Stater, 33024
- Rekruttering
- Research Centers of America ( Hollywood ) ( Site 0009)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 954-990-7649
-
South Miami, Florida, Forenede Stater, 33143
- Rekruttering
- QPS-MRA, LLC-Early Phase ( Site 0001)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 305-722-0970
-
-
Missouri
-
Springfield, Missouri, Forenede Stater, 65802
- Rekruttering
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 417-831-2048
-
-
Nebraska
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Lincoln, Nebraska, Forenede Stater, 68510
- Rekruttering
- Velocity Clinical Research Lincoln ( Site 0007)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 531-530-2800
-
Omaha, Nebraska, Forenede Stater, 68134
- Rekruttering
- Velocity Clinical Research, Omaha ( Site 0008)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 402-933-6500
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43215
- Rekruttering
- Remington-Davis, Inc. ( Site 0005)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 614-487-2560
-
-
Texas
-
League City, Texas, Forenede Stater, 77573
- Rekruttering
- University of Texas Medical Branch ( Site 0004)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 832-340-2313
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health
- Has body mass index (BMI) within 18.0 to 35.0 kg/m^2 (inclusive)
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination
- Has received a pneumococcal polysaccharide vaccine in the previous 10 years, has received any pneumococcal conjugate vaccine at any time prior to this study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part 1: Dose Escalation
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
|
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
|
|
Eksperimentel: Part 2: Dose Expansion
Participants will receive single IM doses of a V132 formulation or comparator regimen.
Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.
|
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
Tidsramme: Up to approximately 30 minutes post vaccination
|
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The percentage of participants with immediate reactions occurring within 30 minutes after any vaccination will be reported.
|
Up to approximately 30 minutes post vaccination
|
|
Percentage of Participants with a Solicited Injection-site Adverse Event
Tidsramme: Up to approximately 7 days post vaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain.
The percentage of participants with a solicited injection-site adverse event will be reported.
|
Up to approximately 7 days post vaccination
|
|
Percentage of Participants with a Solicited Systemic Adverse Event
Tidsramme: Up to approximately 7 days post vaccination
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
The percentage of participants with a solicited systemic adverse event will be reported.
|
Up to approximately 7 days post vaccination
|
|
Percentage of Participants With at Least 1 Unsolicited Adverse Event
Tidsramme: Up to approximately 28 days post vaccination
|
An unsolicited AE is an AE that was not solicited using a vaccination report card (VRC) and that is communicated by a participant (or their legally acceptable representative, if applicable).
Unsolicited AEs include serious and nonserious AEs.
The percentage of participants with at least 1 unsolicited adverse event will be reported.
|
Up to approximately 28 days post vaccination
|
|
Percentage of Participants with a Serious Adverse Event
Tidsramme: Up to approximately 12 months post vaccination
|
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.
The percentage of participants that experienced 1 or more SAEs will be reported.
|
Up to approximately 12 months post vaccination
|
|
Percentage of Participants With at Least 1 Medically Attended Adverse Event
Tidsramme: Up to approximately 12 months post vaccination
|
A medically attended adverse event (MAAE) is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason.
The percentage of participants with at least 1 MAAE will be reported.
|
Up to approximately 12 months post vaccination
|
|
Percentage of Participants Who Experienced an Adverse Event of Clinical Interest
Tidsramme: Up to approximately 12 months post vaccination
|
Events of clinical interest (ECIs) are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
The percentage of participants who experienced an adverse event of clinical interest will be reported.
|
Up to approximately 12 months post vaccination
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)
Tidsramme: Up to approximately 28 days post vaccination
|
Opsonophagocytic activity (OPA) for serotypes in V132 formulations will be determined using a multiplexed opsonophagocytic assay (MOPA).
Geometric Mean Titer (GMT) of serotype-specific OPA will be reported.
|
Up to approximately 28 days post vaccination
|
|
Geometric Mean Fold Rise from Baseline of Serotype-specific OPA
Tidsramme: Baseline (pre-vaccination) and 28 days post vaccination
|
The Geometric Mean Fold Rise (GMFR) from baseline in serotype-specific OPA GMTs for serotypes in V132 formulations will be determined using a multiplexed opsonophagocytic assay (MOPA).
GMFR is defined as the geometric mean of the ratio of concentration at Day 28 post vaccination divided by concentration at baseline.
|
Baseline (pre-vaccination) and 28 days post vaccination
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. august 2026
Primær færdiggørelse (Anslået)
21. juni 2028
Studieafslutning (Anslået)
21. juni 2028
Datoer for studieregistrering
Først indsendt
14. juli 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
17. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- V132-001 (Anden identifikator: MSD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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