A Study of V132 in Healthy Older Participants (V132-001)
31 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Studietype
Ingrijpend
Inschrijving (Geschat)
280
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Toll Free Number
- Telefoonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studie Locaties
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California
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Anaheim, California, Verenigde Staten, 92801
- Werving
- Anaheim Clinical Trials ( Site 0006)
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Contact:
- Study Coordinator
- Telefoonnummer: 714-774-7777
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Florida
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Hallandale, Florida, Verenigde Staten, 33009
- Werving
- Velocity Clinical Research, Hallandale Beach ( Site 0003)
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Contact:
- Study Coordinator
- Telefoonnummer: 954-455-5757
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Hollywood, Florida, Verenigde Staten, 33024
- Werving
- Research Centers of America ( Hollywood ) ( Site 0009)
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Contact:
- Study Coordinator
- Telefoonnummer: 954-990-7649
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South Miami, Florida, Verenigde Staten, 33143
- Werving
- QPS-MRA, LLC-Early Phase ( Site 0001)
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Contact:
- Study Coordinator
- Telefoonnummer: 305-722-0970
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Missouri
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Springfield, Missouri, Verenigde Staten, 65802
- Werving
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
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Contact:
- Study Coordinator
- Telefoonnummer: 417-831-2048
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Nebraska
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Lincoln, Nebraska, Verenigde Staten, 68510
- Werving
- Velocity Clinical Research Lincoln ( Site 0007)
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Contact:
- Study Coordinator
- Telefoonnummer: 531-530-2800
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Omaha, Nebraska, Verenigde Staten, 68134
- Werving
- Velocity Clinical Research, Omaha ( Site 0008)
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Contact:
- Study Coordinator
- Telefoonnummer: 402-933-6500
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Ohio
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Columbus, Ohio, Verenigde Staten, 43215
- Werving
- Remington-Davis, Inc. ( Site 0005)
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Contact:
- Study Coordinator
- Telefoonnummer: 614-487-2560
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Texas
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League City, Texas, Verenigde Staten, 77573
- Werving
- University of Texas Medical Branch ( Site 0004)
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Contact:
- Study Coordinator
- Telefoonnummer: 832-340-2313
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Part 1: Dose Escalation
Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
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Experimental
Experimental
Experimental
Active Comparator
Active Comparator
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Experimenteel: 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.
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Experimental
Experimental
Experimental
Active Comparator
Active Comparator
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
Tijdsspanne: Up to approximately 30 minutes post vaccination
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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.
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Up to approximately 30 minutes post vaccination
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Percentage of Participants with a Solicited Injection-site Adverse Event
Tijdsspanne: Up to approximately 7 days post vaccination
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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.
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Up to approximately 7 days post vaccination
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Percentage of Participants with a Solicited Systemic Adverse Event
Tijdsspanne: Up to approximately 7 days post vaccination
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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.
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Up to approximately 7 days post vaccination
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Percentage of Participants With at Least 1 Unsolicited Adverse Event
Tijdsspanne: 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.
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Up to approximately 28 days post vaccination
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Percentage of Participants with a Serious Adverse Event
Tijdsspanne: Up to approximately 12 months post vaccination
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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.
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Up to approximately 12 months post vaccination
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Percentage of Participants With at Least 1 Medically Attended Adverse Event
Tijdsspanne: Up to approximately 12 months post vaccination
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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.
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Up to approximately 12 months post vaccination
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Percentage of Participants Who Experienced an Adverse Event of Clinical Interest
Tijdsspanne: Up to approximately 12 months post vaccination
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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.
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Up to approximately 12 months post vaccination
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)
Tijdsspanne: 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.
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Up to approximately 28 days post vaccination
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Geometric Mean Fold Rise from Baseline of Serotype-specific OPA
Tijdsspanne: Baseline (pre-vaccination) and 28 days post vaccination
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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.
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Baseline (pre-vaccination) and 28 days post vaccination
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
12 augustus 2026
Primaire voltooiing (Geschat)
21 juni 2028
Studie voltooiing (Geschat)
21 juni 2028
Studieregistratiedata
Eerst ingediend
14 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
14 juli 2026
Eerst geplaatst (Werkelijk)
17 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 september 2026
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- V132-001 (Andere identificatie: MSD)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .