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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01052402




Registration number
NCT01052402
Ethics application status
Date submitted
18/01/2010
Date registered
20/01/2010
Date last updated
9/10/2015

Titles & IDs
Public title
Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents
Scientific title
A Phase 1/2 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years
Secondary ID [1] 0 0
810706
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Avian 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation

Experimental: Dose A - Two intramuscular injections (21 days apart, i.e. Days 0 and 21) of H5N1 Influenza Vaccine (Dose A) followed by a heterologous booster vaccination (Dose A) on Day 360

Experimental: Dose B - Two intramuscular injections (21 days apart, i.e. Days 0 and 21) of H5N1 Influenza Vaccine (Dose B) followed by a heterologous booster vaccination (Dose B) on Day 360


Other interventions: H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and severity of systemic reactions until 7 days after the first vaccination
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization test >= 1:20.
Timepoint [2] 0 0
42 days
Secondary outcome [1] 0 0
Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination
Timepoint [1] 0 0
Day 21, 42 and 381
Secondary outcome [2] 0 0
Fever, malaise or shivering (in children and adolescents aged 3 to 17 years) and fever and irritability (in infants and young children aged 6 to 35 months) with onset within 7 days after the first, second and booster vaccination
Timepoint [2] 0 0
Day 21, 42 and 381
Secondary outcome [3] 0 0
Adverse events observed during the entire study period
Timepoint [3] 0 0
Throughout entire study period
Secondary outcome [4] 0 0
Antibody response associated with protection 21 days after the first and second vaccination, and again at 360 days after the first vaccination and 21 days after the booster vaccination - Antibody response defined as Hemagglutination Inhibition Antibody (HIA) titer >= 1:40 or Single Radial Hemolysis (SRH) area >= 25 mm2, and as measured by Microneutralization (MN) test >= 1:20
Timepoint [4] 0 0
Day 21, 42, 360 and 381
Secondary outcome [5] 0 0
Fold increase of antibody response 21 days after first and second vaccination as compared to baseline, and again at 21 days after the booster vaccination as compared to before the booster vaccination - Measured by MN, HI and SRH assay
Timepoint [5] 0 0
Day 21, 42, 360 and 381
Secondary outcome [6] 0 0
Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination - Measured by MN, HI and SRH assay
Timepoint [6] 0 0
Day 21, 42 and 381

Eligibility
Key inclusion criteria
- 9 to 17 years of age on the day of screening (for Stratum A only)

- 3 to 8 years of age on the day of screening (for Stratum B only)

- 6 to 35 months of age on the day of screening (for Stratum C only)

- Subject who were born at full term of pregnancy (>= 37 weeks) with a birth weight >= 2
kg (for Stratum C only)

- Subjects and/or their parents/legal guardians understand the nature and procedures of
the study and agree to its provisions

- Subjects´ parents/legal guardians provide written consent for participation according
to national law. In case the parents/legal guardians are illiterate, the informed
consent is also to be signed by an independent witness

- Written assent according to subjects´ age and capacity of understanding

- Subjects who are generally healthy, as determined by the investigator's clinical
judgment through collection of medical history and performance of a physical
examination

- Subjects who are physically and mentally capable of participating in the study and
follow its procedures

- Subjects and/or their parents/legal guardians agree to keep a daily record of symptoms
for the duration of the study

- If subjects are female of childbearing potential - have a negative urine pregnancy
test result within 24 hours prior to the scheduled first vaccination and agree to
employ adequate birth control measures for the duration of the study
Minimum age
6 Months
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza
vaccine

- High risk of contracting H5N1 influenza infection (e.g. contact with poultry);

- Subjects who currently have or have a history of a significant neurological,
cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic,
autoimmune, hematological or renal disorder

- Inherited or acquired immunodeficiency

- Subjects who have a disease or are currently undergoing a form of treatment or were
undergoing a form of treatment within 30 days prior to study entry that can be
expected to influence immune response. Such treatment includes, but is not limited to,
systemic or high dose inhaled corticosteroids, radiation treatment or other
immunosuppressive or cytotoxic drugs.

- History of severe allergic reactions or anaphylaxis

- Rash, dermatological condition or tattoos which may interfere with injection site
reaction rating

- Subjects who have received a blood transfusion or immunoglobulins within 90 days prior
to study entry

- Subjects who have received any live vaccine within 4 weeks or inactivated vaccine
within 2 weeks prior to vaccination in this study

- Functional or surgical asplenia

- Subjects with a known or suspected problem with alcohol or drug abuse

- Subjects who were administered an investigational drug within six weeks prior to study
entry or are concurrently participating in a clinical study that includes the
administration of an investigational product

- Dependent relationship with the study site personnel. Dependent relationships include
close relatives (i.e., children, siblings).

- If female: subjects wo are pregnant or lactating

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Espoo
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
Finland
State/province [3] 0 0
Kokkola
Country [4] 0 0
Finland
State/province [4] 0 0
Kuopio
Country [5] 0 0
Finland
State/province [5] 0 0
Oulu
Country [6] 0 0
Finland
State/province [6] 0 0
Pori
Country [7] 0 0
Finland
State/province [7] 0 0
Seinäjoki
Country [8] 0 0
Finland
State/province [8] 0 0
Tampere
Country [9] 0 0
Finland
State/province [9] 0 0
Turku
Country [10] 0 0
Finland
State/province [10] 0 0
Vantaa
Country [11] 0 0
Singapore
State/province [11] 0 0
Singapore
Country [12] 0 0
Spain
State/province [12] 0 0
Paiporta
Country [13] 0 0
Spain
State/province [13] 0 0
Sevilla
Country [14] 0 0
Spain
State/province [14] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ology Bioservices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune
response, immunogenicity of two different doses, antibody persistence 360 days after the
first vaccination, immune response to a heterologous booster given on Day 360) of a Vero
cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents
aged 6 months to 17 years.
Trial website
https://clinicaltrials.gov/show/NCT01052402
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
BioScience Investigator, MD
Address 0 0
Baxter Innovations GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications