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

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ClinicalTrials.gov Identifier: NCT02592486
Recruitment Status : Completed
First Posted : October 30, 2015
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
PPD
Osaka University
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kei Nakashima, Kameda Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumococcal Pneumonia Influenza Biological: Simultaneous administration of Pneumovax NP® and Fluvic HA syringe® Biological: Sequential administration of Pneumovax NP® and Fluvic HA syringe® Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: 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.
Biological: Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine and influenza vaccine simultaneously.
Other Name: Pneumovax NP® and Fluvic HA syringe®

Active Comparator: 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.
Biological: Sequential administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
Other Name: Pneumovax NP® and Fluvic HA syringe®




Primary Outcome Measures :
  1. The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody. [ Time Frame: 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.


Secondary Outcome Measures :
  1. The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody. [ Time Frame: 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.

  2. The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A) [ Time Frame: 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.

  3. The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine. [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592486


Locations
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Japan
Department of Pulmonary Medicine, Kameda Medical Center
Kamogawa, Chiba, Japan, 2968602
Sponsors and Collaborators
Kameda Medical Center
PPD
Osaka University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Kei Nakashima, MD Department of Pulmonary Medicine, Kameda Medical Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kei Nakashima, Assistant Chief, Department of Pulmonary Medicine, Kameda Medical Center
ClinicalTrials.gov Identifier: NCT02592486     History of Changes
Other Study ID Numbers: 15-041-160127
First Posted: October 30, 2015    Key Record Dates
Results First Posted: January 31, 2019
Last Update Posted: January 31, 2019
Last Verified: August 2018
Keywords provided by Kei Nakashima, Kameda Medical Center:
quadrivalent influenza vaccine
23-valent pneumococcal vaccine
immunogenicity
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Influenza, Human
Pneumonia
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs