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

Kameda Medical Center

Status and phase: Completed; Phase 4

Conditions: Influenza; Pneumococcal Pneumonia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02592486

15-041-160127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Simultaneous administration group

Active Comparator group

Description:

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.

Treatment:

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

Sequential administration group

Active Comparator group

Description:

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.

Treatment:

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