The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
NCT ID: NCT02592486
Last Updated: 2019-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2015-11-30
2016-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine and influenza vaccine simultaneously.
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.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
Interventions
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Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine and influenza vaccine simultaneously.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Osaka University
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
Kameda Medical Center
OTHER
Responsible Party
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Kei Nakashima
Assistant Chief, Department of Pulmonary Medicine
Principal Investigators
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Kei Nakashima, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pulmonary Medicine, Kameda Medical Center
Locations
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Department of Pulmonary Medicine, Kameda Medical Center
Kamogawa, Chiba, Japan
Countries
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References
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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.
Other Identifiers
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15-041-160127
Identifier Type: -
Identifier Source: org_study_id
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