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Influenza, AvianPhase 1/2NCT01052402

Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents

A Phase 1/2 study testing H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation in people with Influenza, Avian, run by Alachua Government Services, Inc. at 20 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Avian
What is being tested?
H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
684 participants
Where
20 sitesin 4 countries
Study dates
Dec 2009to Nov 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

Finland10 sites

  • Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus)

    Espoo, 02100

  • South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka)

    Helsinki, 00100

  • Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka)

    Kokkola, 67100

  • Kuopion Vaccine Research Clinic

    Kuopio, 70210

  • Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka)

    Oulu, 90220

  • Porin Vaccine Research Clinic

    Pori, 28100

  • University of Tampere, Seinäjoki Vaccine Research Clinic (Tampereen Yliopisto, Seinajoen Rokotetutkimusklinikka)

    Seinäjoki, 60100

  • Tampere Vacine Research Clinic (Tampereen Rokotetutkimusklinikka)

    Tampere, 33100

  • Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka)

    Turku, 20520

  • University of Tampere, Vantaa East Vaccine Research Clinic (Itä Vantaan Rokotetutkimusklinikka)

    Vantaa, 01300

Other trials in Finland

Spain7 sites

  • Centro de Salud de Paiporta

    Paiporta, 46200

  • Instituto Hispalense de Pediatria, Pediatría - IHP1

    Seville, 41013

  • Centro de Salud Malvarrosa

    Valencia, 46011

  • Centro de Salud Serreria II

    Valencia, 46022

  • Centro de Salud Trafalgar

    Valencia, 46023

  • Centro de Salud de Catarroja

    Valencia, 46470

  • Centro de Salud Quart de Poblet

    Valencia, 46930

Other trials in Spain

Singapore2 sites

  • The Children´s Medical Institute

    Singapore, 119074

  • Mount Elizabeth Medical Centre, The Child and Allergy Clinic

    Singapore, 228510

Other trials in Singapore

Australia1 site

  • Princess Margaret Hospital for Children

    Subiaco, 6008

Other trials in Australia

About this study

Official 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

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.

Being tested
H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Medical subject headings
Influenza in Birds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulationBiological

    Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360

Study groups in NCT01052402
Study groupRoleWhat they receive
Dose AExperimentalTwo 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
Receives: Biological: H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Dose BExperimentalTwo 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
Receives: Biological: H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of systemic reactions until 7 days after the first vaccination

    Measured: 7 days

  2. 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.

    Measured: 42 days

Secondary outcomes (6)

  1. Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination

    Measured: Day 21, 42 and 381

  2. 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

    Measured: Day 21, 42 and 381

  3. Adverse events observed during the entire study period

    Measured: Throughout entire study period

  4. 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

    Measured: Day 21, 42, 360 and 381

  5. 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

    Measured: Day 21, 42, 360 and 381

  6. Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination

    Measured by MN, HI and SRH assay

    Measured: Day 21, 42 and 381

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionNov 2011
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
684 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01052402
Sponsor's protocol ID
810706
Status last verified
Nov 2012
First submitted
18 Jan 2010
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • van der Velden MV, Fritz R, Pollabauer EM, Portsmouth D, Howard MK, Kreil TR, Dvorak T, Fritsch S, Vesikari T, Diez-Domingo J, Richmond P, Lee BW, Kistner O, Ehrlich HJ, Barrett PN, Aichinger G. Safety and immunogenicity of a vero cell culture-derived whole-virus influenza A(H5N1) vaccine in a pediatric population. J Infect Dis. 2014 Jan 1;209(1):12-23. doi: 10.1093/infdis/jit498. Epub 2013 Sep 16.

    PubMed 24041789

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation in people with Influenza, Avian, run by Alachua Government Services, Inc. at 20 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Finland, Spain, Singapore, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of systemic reactions until 7 days after the first vaccination (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01052402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.

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