AzTrials
AzTrials

InfluenzaPhase 2NCT00956046

A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months

A Phase 2 study testing Swine A/H1N1 influenza vaccine (split virion, inactivated) and Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 15 sites in Finland.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: To describe the immune response to vaccines 21 days after each vaccination in all participants. Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for
Influenza, Swine-origin A/H1N1 Influenza
What is being tested?
Swine A/H1N1 influenza vaccine (split virion, inactivated) and Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
401 participants
Where
15 sitesFinland
Study dates
Sep 2009to Jun 2011
Phase
Phase 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 to 35 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • All subjects
  • Aged 6 to 35 months on the day of inclusion
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
  • Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures
  • Completion of vaccination according to the national immunization schedule.
  • Subjects ≥ 6 to < 24 months of age - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
Show all 11Show fewer
  • At Month 8 for antibody persistence assessment:
  • Having received two half-doses of either the formulation 1 or 2 of the vaccine
  • Addendum 1 to Informed Consent Form has been signed and dated by the parents or other legally acceptable representative.
  • At Visit 06, for subjects eligible for the Antibody persistence evaluation who will receive the Trivalent Influenza Vaccine (TIV):
  • Addendum 2 to Informed Consent Form has been signed by the subject's parents/legal representative.

Who cannot join

  • All subjects
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
  • Planned receipt of any vaccine prior to the Day 42 blood sample
  • Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
Show all 20Show fewer
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C as reported by parents/legal representative
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
  • Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
  • Family members of the employees or the Investigator
  • Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
  • Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
  • Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
  • Subjects ≥ 6 to < 24 months of age - History of seizures
  • At Month 8, for antibody persistence assessment:
  • Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Finland15 sites

  • Study site

    Espoo, FIN-02100

  • Study site

    Helsinki, FIN-00100

  • Study site

    Helsinki, FIN-00930

  • Study site

    Jarvenpaa, FIN-04400

  • Study site

    Kokkola, 67100

  • Study site

    Kotka, FIN-48600

  • Study site

    Kuopio, FIN-70100

  • Study site

    Lahti, FIN-15140

  • Study site

    Oulu, FIN-90220

  • Study site

    Pori, FIN-28100

  • Study site

    Seinäjoki, 60100

  • Study site

    Tampere, FIN-33100

  • Study site

    Turku, FIN-20520

  • Study site

    Vantaa, FIN-01300

  • Study site

    Vantaa, FIN-01600

Other trials in Finland

About this study

Official title: Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Primary objectives:

  • To describe the immune response to vaccines 21 days after each vaccination in all participants.
  • To describe the antibody persistence eight months after the first vaccine administration using hemagglutination inhibition (HAI) method in a subset of participants who received two half-doses of either formulation 1 or 2.
  • To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV) administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as primary series.
  • To describe the safety profile of each vaccine in all participants.
Read the detailed description

All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

A subset of the participants eligible who received two half-doses of either formulation 1 or 2 will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination as Follows:

  • Subjects less than 36 months at the time of TIV injection will receive two half-doses and additional sampling for immunogenicity assessment (one before the first TIV vaccination and one 21 days after last TIV vaccination).
  • Subjects aged more than 36 months at the time of TIV injection will receive a full TIV dose and additional sampling for immunogenicity assessment (one before TIV vaccination and one 21 days after TIV vaccination).
Being tested
Swine A/H1N1 influenza vaccine (split virion, inactivated), Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
Keywords
Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Swine-origin Influenza Virus, Infants
Medical subject headings
Influenza, Human

What participants receive

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

  • Swine A/H1N1 influenza vaccine (split virion, inactivated)Biological

    0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).

  • Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)Biological

    0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)

  • Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant)Biological

    0.5 mL, Intramuscular on Day 0 and Day 21

Study groups in NCT00956046
Study groupRoleWhat they receive
A/H1N1 Vaccine Group 1ExperimentalAll participants will receive A/H1N1 Influenza vaccine formulation 1 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
A/H1N1 Vaccine Group 2ExperimentalAll participants will receive A/H1N1 Influenza vaccine formulation 2 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
A/H1N1 Vaccine Group 3ExperimentalParticipants will receive A/H1N1 Influenza vaccine formulation 3
Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant)

What is being measured

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

  1. Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines

    Measured: 21 days post vaccination

  2. Safety: To provide information concerning the safety in terms of solicited injection site and systemic reactions of Swine A/H1N1 influenza vaccines.

    Measured: 0-7 days post-vaccination and entire study duration

Timeline

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

  1. First posted11 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJan 2011
  4. Study completionJun 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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00956046
Sponsor's protocol ID
GPF09
Other IDs
UTN: U1111-1111-5029, 2009-013858-32, 2009
Status last verified
Jan 2014
First submitted
3 Aug 2009
Last updated
14 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Swine A/H1N1 influenza vaccine (split virion, inactivated) and Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 15 sites in Finland.

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 20 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Finland. 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 phase mean?

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?

Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines (time frame: 21 days post vaccination). 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 NCT00956046.

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 14 Jan 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in