UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019552
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

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Basic information

Public 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

Acronym

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

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Pneumococcal Pneumonia, Influenza

Classification by specialty

Medicine in general Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

the percentage of patients with positive antibody response in serotype 23F of pneumococcal antibody (1 month after the dose of pneumococcal vaccine)

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

subjects in simultaneous administration arm receive injections of pneumococcal vaccine and influenza vaccine simultaneously

Interventions/Control_2

subjects in sequential administration arm receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key 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

Target sample size

162


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kei Nakashima

Organization

Kameda Medical Center

Division name

Department of Pulmonary Medicine

Zip code


Address

929 Higashi-cho, Kamogawa city, Chiba, Japan.

TEL

04-7092-2211

Email

kei.7.nakashima@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kei Nakashima

Organization

Kameda Medical Center

Division name

Department of Pulmonary Medicine

Zip code


Address

929 Higashi-cho, Kamogawa city, Chiba, Japan.

TEL

04-7092-2211

Homepage URL


Email

kei.7.nakashima@gmail.com


Sponsor or person

Institute

Department of Pulmonary Medicine, Kameda Medical Center

Institute

Department

Personal name



Funding Source

Organization

MSD KK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT02592486

Org. issuing International ID_1

Clinicaltrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

亀田総合病院 
Kameda Medical Center


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 30 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

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.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 26 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 05 Day

Last follow-up date

2016 Year 08 Month 31 Day

Date of closure to data entry

2016 Year 10 Month 30 Day

Date trial data considered complete

2016 Year 10 Month 30 Day

Date analysis concluded

2017 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 29 Day

Last modified on

2017 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021504


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name