A Study of V132 in Healthy Older Participants (V132-001)
31. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
280
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
-
-
California
-
Anaheim, California, Forente stater, 92801
- Rekruttering
- Anaheim Clinical Trials ( Site 0006)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 714-774-7777
-
-
Florida
-
Hallandale, Florida, Forente stater, 33009
- Rekruttering
- Velocity Clinical Research, Hallandale Beach ( Site 0003)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 954-455-5757
-
Hollywood, Florida, Forente stater, 33024
- Rekruttering
- Research Centers of America ( Hollywood ) ( Site 0009)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 954-990-7649
-
South Miami, Florida, Forente stater, 33143
- Rekruttering
- QPS-MRA, LLC-Early Phase ( Site 0001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 305-722-0970
-
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Missouri
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Springfield, Missouri, Forente stater, 65802
- Rekruttering
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 417-831-2048
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Nebraska
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Lincoln, Nebraska, Forente stater, 68510
- Rekruttering
- Velocity Clinical Research Lincoln ( Site 0007)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 531-530-2800
-
Omaha, Nebraska, Forente stater, 68134
- Rekruttering
- Velocity Clinical Research, Omaha ( Site 0008)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 402-933-6500
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43215
- Rekruttering
- Remington-Davis, Inc. ( Site 0005)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 614-487-2560
-
-
Texas
-
League City, Texas, Forente stater, 77573
- Rekruttering
- University of Texas Medical Branch ( Site 0004)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 832-340-2313
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. august 2026
Primær fullføring (Antatt)
21. juni 2028
Studiet fullført (Antatt)
21. juni 2028
Datoer for studieregistrering
Først innsendt
14. juli 2026
Først innsendt som oppfylte QC-kriteriene
14. juli 2026
Først lagt ut (Faktiske)
17. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- V132-001 (Annen identifikator: MSD)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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