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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592486
• Other study ID #: 15-041-160127
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2018
• Source: Kameda Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Pneumococcal Pneumonia
• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Biological:
• Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine and influenza vaccine simultaneously.
• Sequential administration of Pneumovax NP® and Fluvic HA syringe®
Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.

Locations

Country	Name	City	State
Japan	Department of Pulmonary Medicine, Kameda Medical Center	Kamogawa	Chiba

Sponsors (4)

Lead Sponsor	Collaborator
Kameda Medical Center	Merck Sharp & Dohme Corp., Osaka University, PPD

Country where clinical trial is conducted

Japan, 

References & Publications (5)

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. — View Citation

Grabowska K, Högberg 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
Secondary	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.	Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
Secondary	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.	4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)