Clinical Trials List
2016-03-01 - 2018-10-31
Phase II
Terminated7
ICD-10J09.X2
Influenza due to identified novel influenza A virus with other respiratory manifestations
ICD-10J09
Influenza due to certain identified influenza viruses
A phase II observer-blind, multicentre, dose-ranging study of children 6 to less than 36 months of age who are to be primed with a 2-dose series of GSK Biologicals’ AS03-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine
-
Trial Applicant
GlaxoSmithKline
-
Sponsor
GlaxoSmithKline
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- FANG-LIANG HUANG Division of Pediatrics
- Ming-Chih LIN Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hsiao-chuan Lin Division of Pediatrics
- An-Chyi Chen Division of Pediatrics
- Hung-Chih Lin Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Taiwan National PI
Co-Principal Investigator
- 郭貞孍 Division of Pediatrics
- 傅仁煇 Division of Pediatrics
- 朱世明 Division of Pediatrics
- Chi-Long Chen Division of Pediatrics
- Yhu-Chering Huang Division of Pediatrics
- 林偉豪 Division of Pediatrics
- Jen Fu Hsu Division of Pediatrics
- 謝育嘉 Division of Pediatrics
- 江明洲 Division of Pediatrics
- 林瑞瑩 Division of Pediatrics
The Actual Total Number of Participants Enrolled
15 Terminated
Audit
None
Co-Principal Investigator
- Chun-yi Lu Division of Pediatrics
- 林谷龍 Division of Pediatrics
- 黃文嬋 Division of Pediatrics
- 楊宗儒 Division of Pediatrics
- 賴貞吟 Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- 蔡幸真 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
0.9 µg H5N1 HA antigen adjuvanted with AS03
1.9 µg H5N1 HA antigen adjuvanted with AS03
3.75 µg H5N1 HA antigen adjuvanted with AS03
3.75 µg H5N1 HA antigen adjuvanted with AS03
Dosage Form
Dosage
1.9 μg H5N1 HA
0.9 μg H5N1 HA
1.9 μg H5N1 HA
3.75 μg H5N1 HA
3.75 μg H5N1 HA
Endpoints
Immunogenicity-fever indices
• Humoral immune response in terms of vaccinehomologous HI antibody for each group:
− LL (lower limit) of 95%CI of GMT group ratio at Day
42 using 1.9 µg HA with AS03B as reference
• Humoral immune response in terms of vaccinehomologous MN antibody for each group:
− LL of 95%CI GMT group ratio at Day 42 using 1.9 µg
HA with AS03B as reference
• Fever measurement (≥38°C) post dose 1 and dose 2
− For each subject, a fever index will be calculated using
temperature measurements 3-days post Dose 1 (D0-D2)
and 3-days post Dose 2 (D21-D23)
Immune response to a booster dose
• For immune response in terms of HI antibodies against
vaccine-homologous antigen
− Mean Geometric Increase (MGI) at Day 392 relative to
Day 385
• For the immune response in terms of MN antibodies
against vaccine-homologous antigen
− MGI at Day 392 relative to Day 385
Inclution Criteria
opinion of the investigator, can and will comply with the requirements of the
protocol (e.g., expressed availability for the required study period, ability and
willingness to complete the diary cards and bring the study subject to protocolmandated visits).
Male or female children 6 months to less than 36 months old at the time of the first
vaccination. Children who are not 36 months old as of Day 0, the day of first vaccine
dose under this protocol, can be enrolled.
Written informed consent obtained from the parent(s)/legally acceptable
representative(s) (LAR(s) of the subject prior to performance of any study specific
procedure.
Healthy subjects as established by medical history and standard physical examination
before entering into the study.
Born full-term (i.e., after a gestation period of 37 to less than 42 completed weeks) to
be confirmed by interview with parent/LAR or available medical records.
Exclusion Criteria
Please refer to the glossary of terms for the definition of child in care.
Medical history of physician-confirmed infection with an A/Indonesia/5/2005
(H5N1) virus.
Previous vaccination at any time with an H5N1 vaccine.
Concurrently participating in another clinical study, or use of an investigational or a
non-registered vaccine, pharmaceutical product, or device within 30 days preceding
the first dose of study vaccine, or planned use during the study period.
Presence in the parent(s) / LAR(s) of evidence of substance abuse or of neurological
or psychiatric diagnoses which, even if stable, are deemed by the investigator to
render the parent(s)/LAR(s) unable/unlikely to provide accurate safety reports.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature 38.0°C/100.4°F by any route(axillary
preferred in this study). NOTE: The subject may be vaccinated at a later date,
provided symptoms have resolved and all other eligibility criteria continue to be
satisfied.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
infection) without fever may be enrolled at the discretion of the investigator.
Administration of immunoglobulins, any blood products, or long-acting immunemodifying drugs (e.g. infliximab) during the period starting 3 months before the first
dose of study vaccine, or planned administration during the study period.
History of any neurological disorders or seizures, or Guillain-Barré Syndrome.
Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the
day present almost daily for at least one month), or narcolepsy; or history of
narcolepsy in a subject’s parent or sibling.
Administration of an inactive vaccine within 14 days or of a live attenuated vaccine
within 30 days before the first vaccination.
Planned administration of any vaccine not foreseen by the study protocol between
Day 0 and Day 42 or planned administration of an inactive vaccine within 14 days or
of a live attenuated vaccine within 30 days before through 30 days after the booster
vaccination. Note: routine vaccinations may be provided on Day 42 after all study
assessments have been performed.
History of any reaction or hypersensitivity likely to be exacerbated by any
component of the vaccine (including egg proteins or mercurial preservatives); a
history of anaphylactic-type reaction to consumption of eggs; or a history of severe
adverse reaction to a previous influenza vaccine.
Any medical condition that in the judgment of the investigator would make
intramuscular injection unsafe.
Chronic administration (defined as 14 or more days in total) of immunosuppressants
or other immune-modifying drugs during the period starting six months prior to the
first vaccine. For corticosteroids, this will mean a dose of prednisone or equivalent of
> 2 mg/kg/day of body weight (for persons who weigh < 10 kg), or ≥ 20 mg/day (for
persons who weigh ≥ 10 kg). Inhaled and topical steroids are allowed.
Any confirmed or suspected immunosuppressive or immunodeficient condition,
based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.
Major congenital defects
Any condition which, in the opinion of the investigator, prevents the subject from
participating in the study.
The Estimated Number of Participants
-
Taiwan
90 participants
-
Global
185 participants
