A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults
26. august 2026 oppdatert av: Pfizer
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine.
This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines.
The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC.
Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC.
Each participant will take part in the study for approximately 6 months.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
4670
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
-
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California
-
Lake Forest, California, Forente stater, 92630
- Orange County Research Center
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Walnut Creek, California, Forente stater, 94598
- Diablo Clinical Research, LLC dba Flourish Research
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Connecticut
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Milford, Connecticut, Forente stater, 06460
- Clinical Research Consulting
-
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Florida
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Doral, Florida, Forente stater, 33172
- Suncoast Research Associates
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Miami, Florida, Forente stater, 33176
- Entrust Clinical Research
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Miami Lakes, Florida, Forente stater, 33014
- Palm Springs Community Health Center
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Miami Lakes, Florida, Forente stater, 33016
- Indago Research and Health Center, Inc.
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West Palm Beach, Florida, Forente stater, 33409
- Palm Beach Research Center
-
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Georgia
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Fayetteville, Georgia, Forente stater, 30214
- Javara inc.
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Stockbridge, Georgia, Forente stater, 30281
- Clinical Research Atlanta
-
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Hawaii
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Honolulu, Hawaii, Forente stater, 96814
- East-West Medical Research Institute
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Illinois
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Melrose Park, Illinois, Forente stater, 60160
- DM Clinical Research
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Iowa
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Sioux City, Iowa, Forente stater, 51106
- Velocity Clinical Research, Sioux City
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Michigan
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Grosse Pointe Woods, Michigan, Forente stater, 48236
- Henry Ford St. John Hospital - Thomas Mackey Center for Infectious Disease Research
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Missouri
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Chesterfield, Missouri, Forente stater, 63005
- Clinical Research Professionals
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Nebraska
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Grand Island, Nebraska, Forente stater, 68803
- Velocity Clinical Research, Grand Island
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North Carolina
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Wilmington, North Carolina, Forente stater, 28401
- Accellacare - Wilmington
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Ohio
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Cincinnati, Ohio, Forente stater, 45212
- CTI Clinical Research Center
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South Carolina
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Moncks Corner, South Carolina, Forente stater, 29461
- Clinical Trials of South Carolina
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Myrtle Beach, South Carolina, Forente stater, 29572
- TMA Headlands LLC (d/b/a Trial Management Associates)
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Texas
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Mesquite, Texas, Forente stater, 75149
- SMS Clinical Research LLC
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Sugar Land, Texas, Forente stater, 77478
- DM Clinical Research - Sugar Land
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Tomball, Texas, Forente stater, 77375
- 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, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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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
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age.
Exclusion Criteria:
Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: PG4 Vaccine Lot 1
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
Andre navn:
|
|
Eksperimentell: PG4 Vaccine Lot 2
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
Andre navn:
|
|
Eksperimentell: PG4 Vaccine Lot 3
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
Andre navn:
|
|
Aktiv komparator: 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
20 Valent Pneumococcal Conjugate Vaccine
|
20 Valent Pneumococcal Conjugate Vaccine
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination
Tidsramme: Within 7 days after Vaccination
|
Prompted local reactions after each dose
|
Within 7 days after Vaccination
|
|
Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination
Tidsramme: Within 7 days after Vaccination
|
Prompted systemic events after each dose
|
Within 7 days after Vaccination
|
|
Percentage of Participants with Adverse Events (AEs)
Tidsramme: From Vaccination to 1 month after Vaccination
|
AEs occurring from Dose 1 to 1 month after the vaccination
|
From Vaccination to 1 month after Vaccination
|
|
Percentage of Participants with Serious Adverse Events (SAEs)
Tidsramme: From Vaccination to 6 months after Vaccination
|
SAEs occurring from Dose 1 to 6 months after the vaccination
|
From Vaccination to 6 months after Vaccination
|
|
OPA geometric mean ratios (GMR) between each pair of PG4 vaccine lots
Tidsramme: 1 month after Vaccination
|
OPA GMRs between each pair of PG4 vaccine lots at 1 month after vaccination
|
1 month after Vaccination
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
OPA Serotype-specific geometric mean titers (GMT) for PG4 vaccine serotypes
Tidsramme: 1 month after Vaccination
|
OPA GMTs at 1 month after vaccination
|
1 month after Vaccination
|
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OPA geometric mean fold rise (GMFR) for PG4 vaccine serotypes
Tidsramme: From before vaccination to 1 month after vaccination
|
GMFRs in OPA titers from before to 1 month after vaccination
|
From before vaccination to 1 month after vaccination
|
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Percentages of participants with a ≥4-fold rise in opsonophagocytic activity (OPA) titers
Tidsramme: From Vaccination to 6 months after Vaccination
|
Percentages of participants with a ≥4-fold rise in OPA titers from before to 1 month after vaccination
|
From Vaccination to 6 months after Vaccination
|
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Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ)
Tidsramme: From before vaccination to 1 month after vaccination
|
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ) from before vaccination to 1 month after vaccination
|
From before vaccination to 1 month after vaccination
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
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 (Antatt)
8. september 2026
Primær fullføring (Antatt)
7. juni 2027
Studiet fullført (Antatt)
7. juni 2027
Datoer for studieregistrering
Først innsendt
26. august 2026
Først innsendt som oppfylte QC-kriteriene
26. august 2026
Først lagt ut (Faktiske)
31. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- C4931012
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
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
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .