Unique ID issued by UMIN | UMIN000019552 |
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Receipt number | R000021504 |
Scientific 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 |
Date of disclosure of the study information | 2015/10/30 |
Last modified on | 2017/09/09 06:52:38 |
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
The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
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
The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Japan |
Pneumococcal Pneumonia, Influenza
Medicine in general | Pneumology |
Others
NO
The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
the percentage of patients with positive antibody response in serotype 23F of pneumococcal antibody (1 month after the dose of pneumococcal vaccine)
the positive antibody response in serotype (3, 4, 6B, 14 and 19A), the geometric mean concentrations of specific antibodies to the 6 serotypes (23F, 3, 4, 6B 14 and 19A) , the percentage of patients with seroprotection rate in quadrivalent influenza vaccine
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Vaccine |
subjects in simultaneous administration arm receive injections of pneumococcal vaccine and influenza vaccine simultaneously
subjects in sequential administration arm receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine
65 | years-old | <= |
Not applicable |
Male and Female
adults aged over 65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season
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
162
1st name | |
Middle name | |
Last name | Kei Nakashima |
Kameda Medical Center
Department of Pulmonary Medicine
929 Higashi-cho, Kamogawa city, Chiba, Japan.
04-7092-2211
kei.7.nakashima@gmail.com
1st name | |
Middle name | |
Last name | Kei Nakashima |
Kameda Medical Center
Department of Pulmonary Medicine
929 Higashi-cho, Kamogawa city, Chiba, Japan.
04-7092-2211
kei.7.nakashima@gmail.com
Department of Pulmonary Medicine, Kameda Medical Center
MSD KK
Profit organization
Japan
YES
NCT02592486
Clinicaltrials.gov
亀田総合病院
Kameda Medical Center
2015 | Year | 10 | Month | 30 | Day |
Unpublished
The response rate of serotype 23F in the simultaneous group was not inferior to that in the sequential group. Pneumococcal IgG titers 4 to 6 weeks after vaccination were not significantly different between the groups in all serotypes. Simultaneous administration did not show a significant decrease in the odds ratios for seroprotection rates in H1N1, H3N2, or the B/Phuket influenza strains, apart from B/Texas. There was no increase in adverse reactions with simultaneous administration.
Completed
2015 | Year | 10 | Month | 26 | Day |
2015 | Year | 11 | Month | 05 | Day |
2016 | Year | 08 | Month | 31 | Day |
2016 | Year | 10 | Month | 30 | Day |
2016 | Year | 10 | Month | 30 | Day |
2017 | Year | 07 | Month | 31 | Day |
2015 | Year | 10 | Month | 29 | Day |
2017 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021504
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