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The Objectives of This Study Are Study the Immunogenicity and Safety of the Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Inactivated Split Influenza Vaccine, in Volunteers Who Are Over 60 Years Old

16. december 2021 opdateret af: St. Petersburg Research Institute of Vaccines and Sera

Prospective, Multicenter, Double-blind, Randomized, Comparative Immunogenicity and Safety Trial of Flu-M [Inactivated Split Influenza Vaccine], Solution for Intramuscular Injection, 0.5 ml (FSUE SPbSRIVS FMBA), vs. Ultrix®, Solution for Intramuscular Injection, 0.5 ml (FORT LLC) in Volunteers Aged Over 60 Years

This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The volunteers will include in the trial will divide into two groups:

Group 1: volunteers who will receive one dose of Flu-M, solution for intramuscular injection, 0.5 mL, intramuscularly.

Group 2: volunteers who will receive one dose of Ultrix®, solution for intramuscular administration, 0.5 mL, intramuscularly.

The trial include the following periods and visits:

  1. Screening period (up to 7 days):

    • Visit 0 (day -7...-1).

  2. Vaccination period (up to 1 day):

    • Visit 1 (day 1, randomization, blood collection for serological examination, vaccination).

  3. Follow-up period (up to 28(+2) days):

    • Visit 2 (day 3, organization of trials to assess safety);
    • Visit 3 (day 7(+1), organization of trials to assess safety);
    • Visit 4 (day 21(+2), organization of trials to assess safety, blood collection for serological study);
    • Visit 5 (day 28(+2), organization of trials to assess safety, trial completion);

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

320

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Den Russiske Føderation
      • Saint Petersburg, Den Russiske Føderation
        • LLC "Meditsinskie Tehnologii"
      • Saint Petersburg, Den Russiske Føderation
        • LLC "Strategicheskie Meditsinskie Sistemi"

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Presence of signed informed consent to participate in the trial.
  • Volunteers (both male and female) over the age of 60 who could meet the Protocol requirements.
  • Negative pregnancy test obtained from female volunteers with preserved childbearing potential.
  • Consent to use adequate contraception methods (contraception methods with degree of reliability of more than 90%: a nonhormonal intrauterine device; a spermicide condom; a spermicide cervical cap; spermicide diaphragms) or total sexual abstinence during the clinical trial (until Visit 5 (day 28(+2)).

Exclusion Criteria:

  • Allergic reactions to chicken protein or any previous influenza vaccination.
  • Anamnestic data on the episodes of severe allergic reactions and/or diseases (anaphylaxis, Quincke's edema, polymorphic exudative erythema, serum disease etc.)
  • Acute reaction (temperature above 38.5оС, edema and hyperemia over 5 cm in diameter at the injection site) or complications caused by previous administration of the drug.
  • Previous vaccination 6 months before the start of the trial.
  • History of leucosis, blood cancer, malignant oncological diseases.
  • Guillain-Barré syndrome (acute polyneuropathy) in the medical history.
  • Positive screening for HIV infection, B and C hepatitis, syphilis.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition;
  • Administration of immunoglobulin or blood products within the last three months before the study.
  • Long-term use (more than 14 days) of immunosuppressants (including systemic corticosteroids, cytotoxic, radioactive preparations) or other immunomodulatory drugs for six months before the trial.
  • Chronic diseases at the decompensation stage or in debilitating form, which can make it dangerous for the volunteer to take part in the trial.
  • Progressive neurological disorders, dementia.
  • Blood disorders which serve as a contradiction for intramuscular injection.
  • History of alcohol or drug addiction.
  • Pregnancy, breastfeeding in women with preserved reproductive performance.
  • Current participation in another clinical trial or within the previous 3 months before the screening.
  • Mental, physical and other problems which do not allow for appropriate assessment of own behavior and following the requirements set out in the trial protocol.
  • Any other conditions which in the reasonable opinion of the clinical investigator complicate the participation of the volunteer in the trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Flu-M
160 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative
Biologisk: Flu-M [Inaktiveret split influenzavaccine]
opløsning til intramuskulær injektion, 0,5 ml
Aktiv komparator: Ultrix
160 volunteers were vaccinated with the Ultrix (Inactivated split influenza vaccine)
Biologisk: Inaktiveret split influenzavaccine
opløsning til intramuskulær injektion, 0,5 ml

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunogenicity assessment
Tidsramme: 21 days
Seroconversion rate defined as the percentage of subjects who have a pre-vaccination titer of influenza haemagglutinin antibody titer (HA titer) < 1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline for each strain (A/H1N1, A/H3N2 and B)
21 days

Sekundære resultatmål

Resultatmål
Tidsramme
The percentage of subjects with protective titer of antibodies ≥ 1:40 on the 21(+2) day after the vaccination for each strain (A/H1N1, A/H3N2 and B).
Tidsramme: 21 days
21 days
Increasing of geometric mean titer on the 21(+2) day against the value observed before the use of vaccine for each strain (A/H1N1, A/H3N2 and B)
Tidsramme: 21 days
21 days
The percentage of volunteers with a pre-vaccination HA titer <1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in a post-vaccination HA titer vs. the baseline should be > 30%
Tidsramme: 21 days
21 days
Increasing of geometric mean titer in > 2.0 times
Tidsramme: 21 days
21 days
The percentage with protective antibody titer ≥ 1:40
Tidsramme: 21 days
21 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Petersburg Research Institute of Vaccines and Sera

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. marts 2020

Primær færdiggørelse (Faktiske)

28. maj 2020

Studieafslutning (Faktiske)

24. august 2020

Datoer for studieregistrering

Først indsendt

11. oktober 2021

Først indsendt, der opfyldte QC-kriterier

11. oktober 2021

Først opslået (Faktiske)

22. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. december 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FM-2019-02

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Kliniske forsøg med Influenza

Kliniske forsøg med Flu-M [Inaktiveret split influenzavaccine]

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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