A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
13. august 2026 oppdatert av: Pfizer
A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
540
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
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, India, 530002
- Rekruttering
- King George Hospital
-
-
Karnataka
-
Bangalore, Karnataka, India, 560060
- Rekruttering
- BGS Global Institute of Medical Sciences (BGSGIMS)
-
Bangalore, Karnataka, India, 560085
- Rekruttering
- Radhakrishna Multispeciality Hospital and IVF Center
-
Belagavi, Karnataka, India, 590001
- Rekruttering
- Belagavi Institute of Medical Sciences - Belagavi
-
-
Maharashtra
-
Nashik, Maharashtra, India, 422003
- Rekruttering
- Suyog Hospital
-
-
National Capital Territory of Delhi
-
Dwarka, National Capital Territory of Delhi, India, 110075
- Rekruttering
- Aakash Healthcare Private Limited
-
New Delhi, National Capital Territory of Delhi, India, 110029
- Rekruttering
- All India Institute of Medical Sciences
-
New Delhi, National Capital Territory of Delhi, India, 110060
- Rekruttering
- Sir Ganga Ram Hospital
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302039
- Rekruttering
- Maharaja Agrasen Superspeciality Hospital
-
-
Tamil Nadu
-
Chengalpattu, Tamil Nadu, India, 603203
- Rekruttering
- SRM Medical College Hospital and Research Centre - Kattankulathur
-
Kelambākkam, Tamil Nadu, India, 603103
- Rekruttering
- Chettinad Hospital and Research Institute
-
-
West Bengal
-
Kolkata, West Bengal, India, 700020
- Rekruttering
- Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
-
Kolkata, West Bengal, India, 700020
- Rekruttering
- Institute of Post Graduate Medical Education & Research, SSKM Hospital
-
-
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
Key Inclusion Criteria:
- Participants ≥18 years of age at Visit 1.
- Participants who are ambulatory and live independently in the community.
- Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Applicable to participants 18 through 59 years of age: Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s) that belongs to 1 or more of the following:
- Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)
- Chronic lung disease (ie, COPD, emphysema, asthma, interstitial lung disease, or cystic fibrosis)
- Nongestational diabetes mellitus type 1 or type 2
- Severe obesity (body mass index [BMI] ≥40 kg/m2)
- Chronic liver disease (ie, cirrhosis)
- Chronic kidney disease (not including end-stage renal disease with or without dialysis)
- Chronic neurological disease that causes impaired airway clearance or respiratory muscle weakness (ie, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy)
- Chronic hematologic disease (ie, sickle cell disease or thalassemia)
Note: A chronic medical condition for this study is defined as:
- Duration ≥6 months.
- Requires regular medical follow-up or ongoing prescribed medication or hospitalization in the previous year.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
Key Exclusion Criteria:
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
- Prior history of any subtype of Guillain-Barré syndrome of any etiology.
- Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Placebo
|
|
Eksperimentell: RSVpreF
RSVpreF Vaccine
|
RSVpreF Vaccine
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakere som rapporterte bivirkninger (AEs) gjennom 1 måned etter administrering av undersøkelsesproduktet
Tidsramme: 1 måned etter vaksinasjon
|
Beskriv bivirkninger som oppstår innen 1 måned etter administrering av undersøkelsesproduktet
|
1 måned etter vaksinasjon
|
|
Proportion of participants reporting local reactions within 7 days following investigational product administration
Tidsramme: Within 7 days
|
Describe local reactions following investigational product administration
|
Within 7 days
|
|
Percentage of participants reporting systemic events within 7 days following investigational product administration
Tidsramme: Within 7 days
|
Describe systemic events following investigational product administration
|
Within 7 days
|
|
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Tidsramme: 3 months after vaccination
|
Describe SAEs through 3 months following administration of investigational product
|
3 months after vaccination
|
|
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Tidsramme: Before vaccination, 1 month after vaccination
|
Before vaccination, 1 month after vaccination
|
|
|
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Tidsramme: Before vaccination, 1 month after vaccination
|
Before vaccination, 1 month after vaccination
|
|
|
NTs for RSV A and RSV B expressed as seroresponse rate
Tidsramme: 1 month after vaccination
|
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 (Faktiske)
22. juni 2026
Primær fullføring (Antatt)
25. januar 2027
Studiet fullført (Antatt)
25. januar 2027
Datoer for studieregistrering
Først innsendt
11. juni 2026
Først innsendt som oppfylte QC-kriteriene
11. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- C3671040
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
produkt produsert i og eksportert fra USA
Ja
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. .