Clinical trial NCT02592486: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Pneumonia
Influenza
Keywords: quadrivalent influenza vaccine
23-valent pneumococcal vaccine
immunogenicity
Lead sponsor: Kameda Medical Center
Sponsor class: OTHER
Collaborators: name: PPD Development, LP
name: Osaka University
name: Merck Sharp & Dohme LLC
First posted: 2015-10-30
Enrollment: 162
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
timeFrame: 1month after the dose of PPV23
Secondary outcomes:
measure: The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
timeFrame: 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
measure: The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
timeFrame: Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
measure: The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
timeFrame: 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)
Other outcomes:
Locations:
city: Kamogawa
country: Japan
facility: Department of Pulmonary Medicine, Kameda Medical Center
state: Chiba
Study officials:
affiliation: Department of Pulmonary Medicine, Kameda Medical Center
name: Kei Nakashima, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.