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

Kameda Medical Center162 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

162

Conditions

Pneumococcal Pneumonia Influenza

Interventions

Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®BIOLOGICAL

Injections of pneumococcal vaccine and influenza vaccine simultaneously.

Sequential administration of Pneumovax NP® and Fluvic HA syringe®BIOLOGICAL

Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Pulmonary Medicine, Kameda Medical Center

Kamogawa, Chiba, Japan

Outcomes

Primary Outcomes

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.

Time frame: 1month after the dose of PPV23

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)

Data from ClinicalTrials.gov

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