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

Primary Purpose

Pneumococcal Pneumonia, Influenza

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®

Sequential administration of Pneumovax NP® and Fluvic HA syringe®

About this trial

This is an interventional prevention trial for Pneumococcal Pneumonia focused on measuring quadrivalent influenza vaccine, 23-valent pneumococcal vaccine, immunogenicity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Pulmonary Medicine, Kameda Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Simultaneous administration group

Sequential administration group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT02592486

First Posted

October 28, 2015

Last Updated

August 21, 2018

Sponsor

Kameda Medical Center

Collaborators

PPD, Osaka University, Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02592486

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kameda Medical Center

Collaborators

PPD, Osaka University, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumococcal Pneumonia, Influenza

Keywords

quadrivalent influenza vaccine, 23-valent pneumococcal vaccine, immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simultaneous administration group

Arm Type

Active Comparator

Arm Description

Arm Title

Sequential administration group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®

Other Intervention Name(s)

Pneumovax NP® and Fluvic HA syringe®

Intervention Description

Injections of pneumococcal vaccine and influenza vaccine simultaneously.

Intervention Type

Biological

Intervention Name(s)

Sequential administration of Pneumovax NP® and Fluvic HA syringe®

Other Intervention Name(s)

Pneumovax NP® and Fluvic HA syringe®

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1month after the dose of PPV23

Secondary Outcome Measure Information:

Title

The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.

Description

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)

Title

The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)

Description

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)

Title

The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kei Nakashima, MD

Organizational Affiliation

Department of Pulmonary Medicine, Kameda Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pulmonary Medicine, Kameda Medical Center

City

Kamogawa

State/Province

Chiba

ZIP/Postal Code

2968602

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

20014948

Citation

Walter ND, Taylor TH, Shay DK, Thompson WW, Brammer L, Dowell SF, Moore MR; Active Bacterial Core Surveillance Team. Influenza circulation and the burden of invasive pneumococcal pneumonia during a non-pandemic period in the United States. Clin Infect Dis. 2010 Jan 15;50(2):175-83. doi: 10.1086/649208.

Results Reference

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PubMed Identifier

16771912

Citation

Oishi K, Yoshimine H, Watanabe H, Watanabe K, Tanimura S, Kawakami K, Iwagaki A, Nagai H, Goto H, Kudoh S, Kuriyama T, Fukuchi Y, Matsushima T, Shimada K, Matsumoto K, Nagatake T. Drug-resistant genes and serotypes of pneumococcal strains of community-acquired pneumonia among adults in Japan. Respirology. 2006 Jul;11(4):429-36. doi: 10.1111/j.1440-1843.2006.00867.x.

Results Reference

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PubMed Identifier

19871167

Citation

Hirst GK. THE QUANTITATIVE DETERMINATION OF INFLUENZA VIRUS AND ANTIBODIES BY MEANS OF RED CELL AGGLUTINATION. J Exp Med. 1942 Jan 1;75(1):49-64. doi: 10.1084/jem.75.1.49.

Results Reference

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PubMed Identifier

19556517

Citation

Dransfield MT, Nahm MH, Han MK, Harnden S, Criner GJ, Martinez FJ, Scanlon PD, Woodruff PG, Washko GR, Connett JE, Anthonisen NR, Bailey WC; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Sep 15;180(6):499-505. doi: 10.1164/rccm.200903-0488OC. Epub 2009 Jun 25.

Results Reference

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PubMed Identifier

16549029

Citation

Grabowska K, Hogberg L, Penttinen P, Svensson A, Ekdahl K. Occurrence of invasive pneumococcal disease and number of excess cases due to influenza. BMC Infect Dis. 2006 Mar 20;6:58. doi: 10.1186/1471-2334-6-58.

Results Reference

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PubMed Identifier

29561248

Citation

Nakashima K, Aoshima M, Ohfuji S, Yamawaki S, Nemoto M, Hasegawa S, Noma S, Misawa M, Hosokawa N, Yaegashi M, Otsuka Y. Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial. Hum Vaccin Immunother. 2018;14(8):1923-1930. doi: 10.1080/21645515.2018.1455476. Epub 2018 May 14.

Results Reference

derived

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

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