SYNOPSIS
Name of Sponsor/Company

Title of Study

Daiichi Sankyo Co., Ltd.
Adsorbed cell culture-derived H5N1 influenza virus vaccine
30μg/mL intramuscular injection “Kitasato Daiichi Sankyo”
Inactivated influenza vaccine
Clinical trial of KIB-PCI in healthy pediatric Japanese volunteers

Investigators－Study Centre(s)10 sites

Publication (reference)

None

Studied Period－

Phase of Development

Phase 2/3
To examine the immunogenicity and safety of three different doses(3 μg, 7.5 μg, 15 μg) of KIB-PCI in healthy pediatric Japanesevolunteers
A single center, non-randomized, open-label study

Name of Finished ProductName of Active Ingredient

Objectives

Methodology

Duration of Treatment

Planned:150 subjects (3 μg group: 50 subjects, 7.5 μg group: 50 subjects,
15 μg group: 50 subjects)
Enrolled:
184 subjects (3 μg group: 63 subjects, 7.5 μg group: 63 subjects,
15 μg group: 58 subjects)
Analyzed (Safety):
184 subjects (3 μg group: 63 subjects, 7.5 μg group: 63 subjects,
15 μg group: 58 subjects)
Analyzed (Immunogenicity):
184 subjects (3 μg group: 63 subjects, 7.5 μg group: 63 subjects,
15 μg group: 58 subjects)
Diagnosis:
Healthy Japanese pediatric volunteers
Inclusion:
1) An age range from 6 months to 19 years old at the time of 1stvaccination
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 (report fromlegal representatives is also acceptable)
Test product (batch number):
KIB-PCI 30 μg/mL formulation (PV-0011)
Dosage and administration:
For subjects aged 6 months to 12 years old, two-dose
intramuscular administration of KIB-PCI (0.1 or 0.25 mL) at 3 or7.5 μg (as HA content)
For subjects aged 13 years to 19 years old, two-dose
intramuscular administration of KIB-PCI (0.5 mL) at 15 μg (as HAcontent)
Each vaccination (14 days to 28 days apart) was administered inthe deltoid region on opposite sides of the body.
6 weeks

Reference Therapy, Dose andNone

Number of Patients (plannedand analyzed)

Diagnosis and Main Criteria
for Inclusion

Test Product, Dose and ModeofAdministration,Batch

NumberModeofAdministration,Batch Number
Criteria for Evaluation

Statistical Method

Summary - Conclusion

Date of Report

Primary endpoint:
SRH antibody titer
Secondary endpoint:
Neutralizing antibody titer
The following analyses were carried out in each dose 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 Mean 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 73.02%(60.35 to 83.43) in the 3 μg group, 93.65% (84.53 to 98.24) inthe 7.5 μg group, and 78.95% (66.11 to 88.62) in the 15 μggroup.
The GMTR of SRH antibody titer (95% CI)
approximately 3 weeks after the 2nd vaccination was 7.288(5.838 to 9.098) in the 3 μg group, 11.699 (10.206 to 13.411) inthe 7.5 μg group, and 9.375 (7.415 to 11.852 ) in the 15 μggroup. The seroprotection rate (95% CI) in SRH antibody titer
approximately 3 weeks after the 2nd vaccination was 74.60%(62.06 to 84.73) in the 3 μg group, 92.06% (82.44 to 97.37) inthe 7.5 μg group, and 77.19% (64.16 to 87.26) in the 15 μggroup.
Safety summary:The incidence of adverse events was 73.0% (46/63) in the 3 μggroup, 82.5% (52/63) in the 7.5 μg group, and 84.5% (49/58) inthe 15 μg group. The most frequently reported adverse eventswere injection site pain (36.5% [23/63] in the 3 μg group, 50.8%[32/63] in the 7.5 μg group, and 72.4% [42/58] in the 15 μggroup), injection site erythema (19.0% [12/63], 22.2% [14/63],
and 15.5% [9/58]), and malaise (7.9% [5/63], 4.8% [3/63],20.7% [12/58]). During the study, no SAEs or AEs leading tostudy discontinuation were observed in any groups.
Conclusion:
From these results, it was suggested that two-dose intramuscularadministration of KIB-PCI at 3 or 7.5 μg would have sufficient
immunogenicity for 6-month- to 12-year-old subjects, and 15 μg
would do for 13-year-old to 19 year-old subjects. There wereno significant safety concerns.
October 13, 2016