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)1 sitePublication (reference)

None

Studied Period－

Phase of Development

Phase 2To examine the safety and immunogenicity of two different dosesof KIB-PCI in healthy pediatric Japanese volunteers
A single center, non-randomized, open-label studyName of Finished ProductName of Active Ingredient

Objectives
Methodology

Duration of Treatment

Planned:30 subjects (7 years to 12 years old: 15 subjects, 13 years to 19years old: 15 subjects)
Enrolled:
30 subjects (7 years to 12 years old: 15 subjects, 13 years to 19
years old: 15 subjects)
Analyzed (Safety):
30 subjects (7 years to 12 years old: 15 subjects, 13 years to 19
years old: 15 subjects)
Analyzed (Immunogenicity):
30 subjects (7 years to 12 years old: 15 subjects, 13 years to 19
years old: 15 subjects)
Diagnosis:Healthy Japanese pediatric volunteers
Inclusion:
1) An age range from 7 years to 19 years old at the time ofobtaining 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 (report fromlegal representatives is also acceptable)
Test product (batch number):
KIB-PCI 30 μg/mL formulation (CR-PCI-012)
Dosage and administration:
For subjects aged 7 years to 12 years old, two-dose intramuscularadministration of KIB-PCI (0.1 mL) at 3 μg (as HA content)
For subjects aged 13 years to 19 years old, two-dose
intramuscular administration of KIB-PCI (0.25 mL) at 7.5 μg (asHA content)
Each vaccination (14-28 days apart) was administered in thedeltoid 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

NumberModeofAdministration,

Batch Number
Criteria for Evaluation

Statistical Method

Summary - Conclusion

Date of Report

Primary endpoint:
SRH antibody titer
Secondary endpoint:
HI antibody titer
Neutralizing antibody titer
The following analyses were carried out in each age 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 80.00%(51.91 to 95.67) in the 7 year to 12 year age group and 46.67%(21.27 to 73.41) in the 13 year to 19 year age group. The GMTRof SRH antibody titer (95% CI) approximately 3 weeks after the2nd vaccination was 5.356 (3.456 to 8.301) in the 7 year to 12year age group and 3.333 (1.941 to 5.724) in the 13 year to 19year age group. The seroprotection rate (95% CI) in SRH
antibody titer approximately 3 weeks after the 2nd vaccination
was 80.00% (51.91 to 95.67) in the 7 year to 12 year age groupand 46.67% (21.27 to 73.41) in the 13 year to 19 year age group.
Safety summary:
The incidence of adverse events was 73.3% (11/15) in the 7 year
to 12 year age group and 86.7% (13/15) in the 13 year to 19 year
age group. The most frequently reported adverse events were
injection site pain (33.3% [5/15] in the 7 year to 12 year age
group, and 53.3% [8/15] in the 13 year to 19 year age group),
injection site duration (20.0% [3/15] in the 7 year to 12 year age
group), and malaise (20.0% [3/15] in the 13 year to 19 year age
group). During the study, no SAEs or AEs that lead to study
discontinuation were observed in either group.
Conclusion:
From these results, it was suggested that additional examinationis needed for the 7 year to 12 year age group although two-dose
intramuscular administration of KIB-PCI at 3 μg would havesufficient immunogenicity for this group. For the 13 year to 19year age group, it was suggested that a dose higher than 7.5 μg isneeded to give sufficient immunity. There were no significant
safety concerns.
October 13, 2016