Novel 2009 Influenza H1N1NCT01407978

Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents

A study testing Vaccination with Fluval P monovalent influenza vaccine, Vaccination with Fluval AB and Vaccination with Fluval AB Novo in people with Novel 2009 Influenza H1N1 and Influenza, Human, run by Fluart Innovative Vaccine Ltd, Hungary at 1 site in Hungary.

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

This is a single-blind, reference drug controlled study to assess safety and tolerability of FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. Read more about this study

Who is it for?: Ages 3 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Novel 2009 Influenza H1N1, Influenza, Human
What is being tested?: Vaccination with Fluval P monovalent influenza vaccine, Vaccination with Fluval AB and Vaccination with Fluval AB Novo
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteHungary
Study dates: Aug 2009to Mar 2010
Phase: Interventional
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 3 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Children aged 3 to 12 years, adolescents aged 12 to 18 years, both sexes;
Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes)m such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study.
Female volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method (includes implants, injectibles, combined oral contraceptives, effective intrauterine devices /IUDs/, sexual abstinence, or a vasectomized partner) or abstinence throughout the trial and not become pregnant for the duration of the study.
Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures;
Absence of existence of any exclusion criteria.

Who cannot join

Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
Known allergy to eggs or other components of the vaccine (in particular mercury);
History of Guillain-Barré syndrome;
Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
Immunosuppressive therapy in the preceding 36 months;
Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids (local corticosteroid or corticosteroid nasal spray are permitted);

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Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
Documented HIV, HBV or HCV infection;
Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immunoresponse;
Acute febrile respiratory illness within one week prior to vaccination;
Vaccine therapy within 4 weeks prior to vaccination;
Influenza vaccination within 6 months prior to vaccination;
Experimental drug therapy within 1 month prior to vaccination;
Past or current psychiatric disease of the volunteer or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer or the legitimate representative;
Alcohol or drug abuse of the participant or the legitimate representative.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

"Csolnoky Ferenc" Veszprém County Hospital
Veszprém, Veszprém megye, 8200

Other trials in Hungary

About this study

Official title: Tolerability and Immunogenicity Study of FLUVAL P H1N1 Monovalent Influenza Vaccine of Omninvest in Children and Adolescents

Read the detailed description

Primary Objective:

To assess tolerability/safety (incidence of adverse events 21-28 days following vaccination) of the study drug.

Secondary Objectives:

To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups.
To assess long term (180-210 days following vaccination) tolerability/safety (incidence of adverse events) of the study drug.

Conditions: Novel 2009 Influenza H1N1, Influenza, Human
Being tested: Vaccination with Fluval P monovalent influenza vaccine, Vaccination with Fluval AB, Vaccination with Fluval AB Novo
Keywords: Influenza, Pandemic vaccine, Seasonal vaccine, Prevention, Influenza vaccine, Influenza in humans, Pandemic influenza in humans, Influenza vaccine for children, Influenza vaccine for adolescents, Seasonal vaccine for children, Seasonal vaccine for adolescents
Medical subject headings: Influenza, Human

What participants receive

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

Vaccination with Fluval P monovalent influenza vaccineBiological
Also called Fluval P, FL-P-K-01/09
- Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.
- Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose.
Vaccination with Fluval ABBiological
Also called Fluval AB, 5609
- Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.
- Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose.
Vaccination with Fluval AB NovoBiological
Also called Fluval AB Novo, FL-K-13/09
- Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.
- Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose.

Study groups in NCT01407978
Study group	Role	What they receive
Vaccination with Fluval AB Novo	Active comparator	* Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose. Receives: Biological: Vaccination with Fluval AB Novo
Vaccination with Fluval AB	Active comparator	* Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose. Receives: Biological: Vaccination with Fluval AB
Vaccination with Fluval P	Experimental	* Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose. Receives: Biological: Vaccination with Fluval P monovalent influenza vaccine

What is being measured

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

Incidence of adverse events
Measured: 21-28 days after vaccination

Secondary outcomes (2)

Post vaccination HI antibody titer
Measured: 21-28 days after vaccination
Incidence of adverse events
Measured: 180-210 days after vaccination

Timeline

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

Aug 2009Mar 2010

First posted2 Aug 2011 (estimated)
Study startAug 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Novel 2009 Influenza H1N1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01407978
Sponsor's protocol ID: FLUVAL P-H-07
Status last verified: May 2012
First submitted: 30 Mar 2010
Last updated: 21 May 2012
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tolerability and Immunogenicity Study of FLUVAL P H1N1 Monovalent Influenza Vaccine of Omninvest in Children and Adolescents
ClinicalTrials.gov ID: NCT01407978
Acronym / sponsor ID: FLUVAL P-H-07
Conditions: Novel 2009 Influenza H1N1, Influenza, Human
Keywords: Influenza, Pandemic vaccine, Seasonal vaccine, Prevention, Influenza vaccine, Influenza in humans, Pandemic influenza in humans, Influenza vaccine for children
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 2 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective:

To assess tolerability/safety (incidence of adverse events 21-28 days following vaccination) of the study drug.

Secondary Objectives:

To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups.
To assess long term (180-210 days following vaccination) tolerability/safety (incidence of adverse events) of the study drug.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Vaccination with Fluval AB Novo	Active comparator	Biological: Vaccination with Fluval AB Novo* Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose.
Vaccination with Fluval AB	Active comparator	Biological: Vaccination with Fluval AB* Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose.
Vaccination with Fluval P	Experimental	Biological: Vaccination with Fluval P monovalent influenza vaccine* Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose.

Who may qualify

Ages: 3 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Children aged 3 to 12 years, adolescents aged 12 to 18 years, both sexes;
Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes)m such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study.
Female volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method (includes implants, injectibles, combined oral contraceptives, effective intrauterine devices /IUDs/, sexual abstinence, or a vasectomized partner) or abstinence throughout the trial and not become pregnant for the duration of the study.
Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures;
Absence of existence of any exclusion criteria.

Key exclusion criteria (15 listed)

Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
Known allergy to eggs or other components of the vaccine (in particular mercury);
History of Guillain-Barré syndrome;
Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
Immunosuppressive therapy in the preceding 36 months;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vaccination with Fluval P monovalent influenza vaccineAlso: Fluval P, FL-P-K-01/09* Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose.	Biological	Vaccination with Fluval P
Vaccination with Fluval ABAlso: Fluval AB, 5609* Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose.	Biological	Vaccination with Fluval AB
Vaccination with Fluval AB NovoAlso: Fluval AB Novo, FL-K-13/09* Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose.	Biological	Vaccination with Fluval AB Novo

Primary outcome

Incidence of adverse events
Time frame: 21-28 days after vaccination

2 secondary outcomes

Post vaccination HI antibody titer
Time frame: 21-28 days after vaccination
Incidence of adverse events
Time frame: 180-210 days after vaccination

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Ősi, Dr. study director

Omninvest Ltd.

Éva Szabó, MD principal investigator

"Csolnoky Ferenc" Veszprém County Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 15 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. 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.

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?

Incidence of adverse events (time frame: 21-28 days after vaccination). 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 NCT01407978.

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 21 May 2012.