Skip to main content
OpenTrials
Completed

NCT Number: NCT02592486

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pneumococcal Pneumonia Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Influenza Influenza, Human Lung Diseases Orthomyxoviridae Infections Pneumococcal Infections Pneumonia Pneumonia, Bacterial Pneumonia, Pneumococcal RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pulmonary Medicine, Kameda Medical Center

Kamogawa, Chiba, 2968602, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®

Biological

Injections of pneumococcal vaccine and influenza vaccine simultaneously.

Other names: Pneumovax NP® and Fluvic HA syringe®

Sequential administration of Pneumovax NP® and Fluvic HA syringe®

Biological

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

Other names: Pneumovax NP® and Fluvic HA syringe®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kameda Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Osaka University
  • PPD Development, LP

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.