AzTrials
AzTrials

InfluenzaPhase 1/2NCT00976469

A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents

A Phase 1/2 study testing H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated) and Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011 in people with Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 6 sites in 2 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 determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety. 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, Pandemic Influenza
What is being tested?
H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated) and Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
6 sitesin 2 countries
Study dates
Sep 2009to Mar 2011
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

  • Written informed consent provided by subject's parent(s) / legal guardian(s) (according to national law)
  • Written assent provided by subject according to age and capacity of understanding
  • Subject is 9 to 17 years (Stratum A), 3 to 8 years (Stratum B), 12 to 35 months (Stratum C) or 6 to 11 months of age (Stratum D) at the time of screening
  • Subject was born at full term of pregnancy (>= 37 weeks) with a birth weight >= 2 kg (Strata C and D) Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the subject diary)
  • If female of childbearing potential, subject presents with a negative urine pregnancy test within 24 hours prior to the first vaccination and agrees to employ adequate birth control measures for the duration of the study
  • Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
  • Subject is physically and mentally capable of participating in the study

Who cannot join

  • Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological product or device during the course of this study
  • Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
  • Subject has any inherited or acquired immune deficiency
  • Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
  • Subject has a history of testing positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this clinical study.
  • Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could 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.
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  • Subject has a history of severe allergic reactions or anaphylaxis
  • Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating
  • Subject has received a blood transfusion or immunoglobulins within 90 days of study entry
  • Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study Subject has functional or surgical asplenia
  • Subject has a known or suspected problem with alcohol or drug abuse
  • Subject or one of subject's parent(s) / legal guardian(s) is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, siblings, partner/spouse, parents) as well as employees of the investigator or site personnel conducting the study
  • Subject is pregnant or lactating

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Austria3 sites

  • General Practice

    Eferding, Upper Austria, 4070

  • Allgemeines Krankenhaus (AKH) der Stadt Wien (General Hospital Vienna)

    Vienna, 1090

  • General Practice

    Wels, Upper Austria, 4600

Other trials in Austria

Germany3 sites

  • General Practice

    Ettenheim, 77955

  • General Practice

    Kehl, 77694

  • General Practice

    Mönchengladbach, 41236

Other trials in Germany

About this study

Official title: An Open-Label Phase 1/2 Study to Assess the Immunogenicity and Safety of Two Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years

The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety.

Being tested
H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated), Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011
Medical subject headings
Influenza, Human

What participants receive

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

  • H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)Biological

    2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age

  • Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011Biological

    Also called Inflexal V

    Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)

Study groups in NCT00976469
Study groupRoleWhat they receive
Dose A (3.75 µg HA antigen, 0.25 mL)ExperimentalWithin each age stratum (4 age strata) subjects will be randomized 1:1 to receive two vaccinations of either Dose A (3.75 µg) or Dose B (7.5 µg) of H1N1 pandemic influenza vaccine at a 21-day interval.
Receives: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)
Dose B (7.5µg HA antigen, 0.5 mL)ExperimentalWithin each age stratum (4 age strata) subjects will be randomized 1:1 to receive two vaccinations of either Dose A (3.75 µg) or Dose B (7.5µg) of H1N1 pandemic influenza vaccine at a 21-day interval. A booster vaccination with a licensed seasonal trivalent influenza vaccine for the season 2010/2011 will be administered to at least 30 subjects in each age stratum (who have received Dose B) at 360 days after the first vaccination.
Receives: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated); Biological: Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011

What is being measured

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

  1. To assess the immune response to two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years

    Measured: 42 days

  2. To assess the safety of two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years

    Measured: Within 7 days after each vaccination

Timeline

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

  1. First posted14 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionApr 2010
  4. Study completionMar 2011

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
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976469
Sponsor's protocol ID
820903
Other IDs
EUDRACT Number 2009-013131-38
Status last verified
May 2011
First submitted
11 Sep 2009
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Loew-Baselli A, Pavlova BG, Fritsch S, Poellabauer EM, Draxler W, Kistner O, Behre U, Angermayr R, Neugebauer J, Kirsten K, Forster-Waldl E, Koellges R, Ehrlich HJ, Barrett PN. A non-adjuvanted whole-virus H1N1 pandemic vaccine is well tolerated and highly immunogenic in children and adolescents and induces substantial immunological memory. Vaccine. 2012 Sep 7;30(41):5956-66. doi: 10.1016/j.vaccine.2012.07.039. Epub 2012 Jul 28.

    PubMed 22846396

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated) and Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011 in people with Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 6 sites in 2 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 7 inclusion and 13 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 6 sites in Austria, Germany. 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?

To assess the immune response to two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years (time frame: 42 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 NCT00976469, 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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