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The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine

21. august 2018 opdateret af: Kei Nakashima, Kameda Medical Center

A Randomized, Open-label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine

The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. We compare the immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine with that of separate administration.

162 Participants are randomly assigned to one of the two study groups; Simultaneous administration group: receive injections of pneumococcal vaccine and influenza vaccine simultaneously.

Sequential administration group: receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.

We compare the immunogenicity of the two groups.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

162

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Japan
    • Chiba
      • Kamogawa, Chiba, Japan, 2968602
        • Department of Pulmonary Medicine, Kameda Medical Center

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season

Exclusion Criteria:

  • a sensitivity to pneumococcal and influenza vaccine
  • received other inactivated vaccine within 14 days
  • received other live vaccine within 28 days
  • the presence of conditions known to impair pneumococcal vaccine response
  • having malignant disease
  • taking oral corticosteroids or immunosuppressive agent
  • history of splenectomy
  • history of an acute febrile illness or signs of severe acute illness at the time of vaccination
  • other inappropriate condition to receive vaccination
  • suffering an acute illness requiring antibiotics or steroids within the past month
  • not expected to survive 12 months were also excluded

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Simultaneous administration group
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Biologisk: Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine and influenza vaccine simultaneously.
Andre navne:
  • Pneumovax NP® and Fluvic HA syringe®
Aktiv komparator: Sequential administration group
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Biologisk: Sequential administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
Andre navne:
  • Pneumovax NP® and Fluvic HA syringe®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
Tidsramme: 1month after the dose of PPV23
The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody.
1month after the dose of PPV23

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
Tidsramme: 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
Positive antibody response was defined as ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination in respective serotypes of the pneumococcal antibody.
4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Tidsramme: Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
Pneumococcal IgG concentrations were converted using natural log transformations and presented as a geometric mean concentration.
Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
Tidsramme: 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)
Seroprotection rates (post-vaccination titer ≥1:40) were calculated to assess the immunogenicity of influenza vaccination.
4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)

Samarbejdspartnere og efterforskere

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

Sponsor

Kameda Medical Center

Samarbejdspartnere

Merck Sharp & Dohme LLC
PPD
Osaka University

Efterforskere

  • Ledende efterforsker: Kei Nakashima, MD, Department of Pulmonary Medicine, Kameda Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. november 2015

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

28. oktober 2015

Først indsendt, der opfyldte QC-kriterier

29. oktober 2015

Først opslået (Skøn)

30. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-041-160127

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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