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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pneumococcal Pneumonia, Influenza

Intervention / Treatment
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* Biological: Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®
* Biological: Sequential administration of Pneumovax NP® and Fluvic HA syringe®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simultaneous administration group<br>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®<br>* Injections of pneumococcal vaccine and influenza vaccine simultaneously.<br>* Other names: Pneumovax NP® and Fluvic HA syringe®;|
| Active Comparator: Sequential administration group<br>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®<br>* Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.<br>* Other names: Pneumovax NP® and Fluvic HA syringe®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody. | 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) | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadrivalent influenza vaccine, 23-valent pneumococcal vaccine, immunogenicity