SYNOPSIS
Name of Sponsor/Company
Name of Finished ProductName of Active IngredientDaiichi Sankyo Co., Ltd.
Adsorbed cell culture-derived H5N1 influenza virus vaccine
30μg/mL intramuscular injection “Kitasato Daiichi Sankyo”
Adsorbed cell culture-derived H5N1 influenza virus vaccine
60μg/mL intramuscular injection “Kitasato Daiichi Sankyo”

Investigators

Inactivated influenza vaccine
Confirmatory clinical trial of KIB-PCI in healthy adult Japanesevolunteers－Study Centre(s)3 sitesPublication (reference)

None

Studied Period－Phase of Development

Duration of Treatment

Phase 2/3
To assess the immunogenicity and safety of two different doses ofKIB-PCI in healthy adult Japanese volunteers
A double-blind, randomized, two-arm, dose-comparing multicenter
study
Planned:600 subjects (30 μg group: 300 subjects, 60 μg group: 300 subjects)
Enrolled:
602 subjects (30 μg group: 300 subjects, 60 μg group: 302 subjects)
Analyzed (Safety):
600 subjects (30 μg group: 298 subjects, 60 μg group: 302 subjects)
Analyzed (Immunogenicity):
596 subjects (30 μg group: 297 subjects, 60 μg group: 299 subjects)
Diagnosis:
Healthy Japanese adult volunteers
Inclusion:
1) An age range from 20 to 64 years old at the time of obtaining
informed consents
2) A subject without any health problems to participate in thestudy, judged by investigators or sub investigators
3) Able to comply with all trial procedures, take examinations
stipulated in the protocol, and report their symptoms
Test product (batch number):
KIB-PCI 30 μg/mL formulation (CR-PCI-012)
KIB-PCI 60 μg/mL formulation (CR-PCI-015)
Dosage and administration:
Two-dose intramuscular administration of KIB-PCI (1 mL) at 30or 60 μg (as HA content)
Each vaccination (14-28 days apart) was administered in thedeltoid region on opposite sides of the body.
6 weeks

Reference Therapy, Dose andNone

Title of Study

Objectives
Methodology
Number of Patients (plannedand analyzed)

Diagnosis and Main Criteria
for Inclusion

Test Product, Dose and Modeof Administration, Batch
NumberModeofAdministration,

Batch Number
Criteria for Evaluation

Primary endpoint:
SRH antibody titer against the H5 antigen
Secondary endpoint:

Statistical Method

Summary - Conclusion

Date of Report

HI antibody titer against the H5 antigen
Neutralizing antibody titer against the H5N1 influenza virus
The following analyses were carried out in each group
1) Seroconversion rate
For SRH antibody titer, the seroconversion rates with their 95%
confidence intervals (95% CIs) were calculated at approximately 3
weeks after each vaccination.
2) Geometric Means Titer Ratio (GMTR)
For SRH antibody titer, GMTRs with their 95% CIs on the basis ofgeometric mean titer (GMT) before the 1st vaccination werecalculated at approximately 3 weeks after each vaccination.
3) Seroprotection rate
For SRH antibody titer, the seroprotection rates with their 95% CIs
were calculated at approximately 3 weeks after each vaccination.
Immunogenicity summary:
The seroconversion rate (95% CI) in SRH antibody titer
approximately 3 weeks after the 2nd vaccination was 65.97%(60.18 to71.43) in the 30 μg group and 78.13% (72.90 to 82.76)
in the 60 μg group. The GMTR of SRH antibody titer (95% CI)
approximately 3 weeks after the 2nd vaccination was 5.595(5.028 to 6.226) in the 30 μg group and 7.014 (6.351 to 7.746) inthe 60 μg group. The seroprotection rate (95% CI) in SRH
antibody titer approximately 3 weeks after the 2nd vaccination
was 65.97% (60.18 to 71.43) in the 30 μg group and 77.08%(71.79 to 81.81) in the 60 μg group. The increases in SRH
antibody titer were observed in both groups.
Safety summary:
The incidence of adverse events was 84.9% (253/298) in the30 μg group and 85.8% (259/302) in the 60 μg group. The mostfrequently reported adverse events were injection site pain,
injection site erythema, and malaise in both groups and theirincidences were similar in the 30 μg group and 60 μg group:
70.5% (210/298) vs. 74.8% (226/302) for injection site pain,25.8% (77/298) vs. 25.8% (78/302) for injection site erythema,and 26.5% (79/298) vs. 29.1% (88/302) for malaise. Other thanthose above, the incidence of each adverse event was similar in
the two groups. During the study, only one subject in the 30 μggroup experienced SAE (Intestinal obstruction), which wasassessed as not related to the study drug. The subject recoveredfrom this SAE.
Conclusion:
From these results, it was suggested that two-dose intramuscularadministration of KIB-PCI at 30 or 60 μg had sufficient
immunogenicity. There were no major differences in the incidenceof each type of adverse events between the 30 μg group and the60 μg groups. In conclusion, both of these dosages had no
significant safety concerns.
March 12, 2015