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

NCT02592486 | Completed Phase 4 Results

• 1 other identifier: 15-041-160127
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Pneumonia; Influenza

Keywords

quadrivalent influenza vaccine; 23-valent pneumococcal vaccine; immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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.

  1month after the dose of PPV23

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Simultaneous administration group

ACTIVE COMPARATOR

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.

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

Sequential administration group

ACTIVE COMPARATOR

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.

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

Interventions

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

Injections of pneumococcal vaccine and influenza vaccine simultaneously.

Also known as: Pneumovax NP® and Fluvic HA syringe®

Simultaneous administration group

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

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

Also known as: Pneumovax NP® and Fluvic HA syringe®

Sequential administration group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season

You may not qualify if:

• 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

Sponsors & Collaborators

• Kameda Medical Center: lead
• PPD Development, LP: collaborator
• Osaka University: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Department of Pulmonary Medicine, Kameda Medical Center

Kamogawa, Chiba, 2968602, Japan

Location

Related Publications (6)

• 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.

  PMID: 20014948 BACKGROUND

• 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.

  PMID: 16771912 BACKGROUND

• 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.

  PMID: 19871167 BACKGROUND

• 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.

  PMID: 19556517 BACKGROUND

• 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.

  PMID: 16549029 BACKGROUND

• 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.

  PMID: 29561248 DERIVED

MeSH Terms

Conditions

Pneumonia, Pneumococcal; Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kei Nakashima, Associate Chief
• Organization: Department of Pulmonary Medicine, Kameda Medical Center

kei.7.nakashima@gmail.com

81-4-7092-2211

Study Officials

• Kei Nakashima, MD

  Department of Pulmonary Medicine, Kameda Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Chief, Department of Pulmonary Medicine

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 30, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-08

Locations

JP (1)