Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules
3. april 2014 oppdatert av: Novartis Vaccines
A Phase IV, Multi-center, Randomized, Open-label Study of PCECV (Rabipur®) Comparing the Immunogenicity and Safety of Two Different Simulated Post Exposure Schedules (Zagreb 2-1-1 Versus Essen Regimen 1-1-1-1-1) in Healthy Indian Subjects
This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
250
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
KA
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Bangalore, KA, India, 560070
- Kempegowda Institute of Medical Sciences Hospital (KIMS)
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Mandya, KA, India, 571401
- Mandya Institute Of Medical Sciences
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MS
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Pune, MS, India, 411018
- Padmashree Dr. D.Y Patil Hospital
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Males and females of age ≥ 18 years.
- Individuals who had given written consent.
- Individuals in good health and available for all the visits scheduled in the study.
Exclusion Criteria:
- Pregnancy or unwillingness to practice acceptable contraception.
- A history of Rabies vaccination.
- History of allergy to egg protein.
- Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
- A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
- Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
- Treatment with an anti-malarial drug, up to two months prior to the study.
- Individuals who received any other vaccines within 28 days prior to enrollment.
- Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- Any planned surgery during the study period.
- Subjects who have cancer disorders excluding nonmelanotic skin cancer.
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group A-Zagreb
Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)
|
Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.
|
|
Aktiv komparator: Group B-Essen
Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14, and 28)
|
Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14
Tidsramme: On Day 0 and Day 14
|
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule
|
On Day 0 and Day 14
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42
Tidsramme: Study day 7, 14 and 42
|
Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
|
Study day 7, 14 and 42
|
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Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations
Tidsramme: Day 0, Day 7, Day 14 and Day 42
|
Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules
|
Day 0, Day 7, Day 14 and Day 42
|
|
Percentages of Subjects Reporting Adverse Events (AEs)
Tidsramme: All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period
|
Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner).
All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.
|
All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period
|
Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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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
1. juli 2011
Primær fullføring (Faktiske)
1. november 2011
Studiet fullført (Faktiske)
1. november 2011
Datoer for studieregistrering
Først innsendt
30. mai 2011
Først innsendt som oppfylte QC-kriteriene
1. juni 2011
Først lagt ut (Anslag)
3. juni 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. mai 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. april 2014
Sist bekreftet
1. april 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- V49_25
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