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

Phase 4

Completed

Interventions: Biological: Sequential administration of Pneumovax NP® and Fluvic HA syringe®
Biological: Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sequential administration group	Sequential administration of Pneumovax NP® and Fluvic HA syringe®	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.
Simultaneous administration group	Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®	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.

Primary Outcome Measures

Name	Time	Method
The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.	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

Name	Time	Method
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.	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.
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.	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.
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)	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.