The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
21 augusti 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
162
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Chiba
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Kamogawa, Chiba, Japan, 2968602
- Department of Pulmonary Medicine, Kameda Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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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.
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Injections of pneumococcal vaccine and influenza vaccine simultaneously.
Andra namn:
|
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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.
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Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
Tidsram: 1month after the dose of PPV23
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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.
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1month after the dose of PPV23
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
Tidsram: 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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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.
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4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Tidsram: Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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Pneumococcal IgG concentrations were converted using natural log transformations and presented as a geometric mean concentration.
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Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
Tidsram: 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)
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Seroprotection rates (post-vaccination titer ≥1:40) were calculated to assess the immunogenicity of influenza vaccination.
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4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kei Nakashima, MD, Department of Pulmonary Medicine, Kameda Medical Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Walter ND, Taylor TH, Shay DK, Thompson WW, Brammer L, Dowell SF, Moore MR; Active Bacterial Core Surveillance Team. Influenza circulation and the burden of invasive pneumococcal pneumonia during a non-pandemic period in the United States. Clin Infect Dis. 2010 Jan 15;50(2):175-83. doi: 10.1086/649208.
- Oishi K, Yoshimine H, Watanabe H, Watanabe K, Tanimura S, Kawakami K, Iwagaki A, Nagai H, Goto H, Kudoh S, Kuriyama T, Fukuchi Y, Matsushima T, Shimada K, Matsumoto K, Nagatake T. Drug-resistant genes and serotypes of pneumococcal strains of community-acquired pneumonia among adults in Japan. Respirology. 2006 Jul;11(4):429-36. doi: 10.1111/j.1440-1843.2006.00867.x.
- Hirst GK. THE QUANTITATIVE DETERMINATION OF INFLUENZA VIRUS AND ANTIBODIES BY MEANS OF RED CELL AGGLUTINATION. J Exp Med. 1942 Jan 1;75(1):49-64. doi: 10.1084/jem.75.1.49.
- Dransfield MT, Nahm MH, Han MK, Harnden S, Criner GJ, Martinez FJ, Scanlon PD, Woodruff PG, Washko GR, Connett JE, Anthonisen NR, Bailey WC; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Sep 15;180(6):499-505. doi: 10.1164/rccm.200903-0488OC. Epub 2009 Jun 25.
- Grabowska K, Hogberg L, Penttinen P, Svensson A, Ekdahl K. Occurrence of invasive pneumococcal disease and number of excess cases due to influenza. BMC Infect Dis. 2006 Mar 20;6:58. doi: 10.1186/1471-2334-6-58.
- Nakashima K, Aoshima M, Ohfuji S, Yamawaki S, Nemoto M, Hasegawa S, Noma S, Misawa M, Hosokawa N, Yaegashi M, Otsuka Y. Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial. Hum Vaccin Immunother. 2018;14(8):1923-1930. doi: 10.1080/21645515.2018.1455476. Epub 2018 May 14.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2015
Primärt slutförande (Faktisk)
1 mars 2016
Avslutad studie (Faktisk)
1 augusti 2016
Studieregistreringsdatum
Först inskickad
28 oktober 2015
Först inskickad som uppfyllde QC-kriterierna
29 oktober 2015
Första postat (Uppskatta)
30 oktober 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 januari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 augusti 2018
Senast verifierad
1 augusti 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Lunginflammation
- Lungsjukdomar
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Streptokockinfektioner
- Gram-positiva bakteriella infektioner
- Lunginflammation, bakteriell
- Orthomyxoviridae-infektioner
- Pneumokockinfektioner
- Lunginflammation, Pneumokocker
- Influensa, människa
- Läkemedels fysiologiska effekter
- Immunologiska faktorer
- Heptavalent pneumokockkonjugatvaccin
Andra studie-ID-nummer
- 15-041-160127
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .