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InfluenzaPhase 3NCT01210898

Immunogenicity and Safety of V70P5 Revaccination Subjects

A Phase 3 study testing Adjuvanted seasonal influenza vaccine in people with Influenza, run by Novartis Vaccines at 16 sites in Finland.

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 study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine. Read more about this study

Who is it for?
Ages 18 to 96 monthsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Adjuvanted seasonal influenza vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
16 sitesFinland
Study dates
Sep 2010to Dec 2011
Phase
Phase 3
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 18 to 96 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy male or female children that have previously participated in the V70P5 study in Finland.

Who cannot join

  • Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Finland16 sites

  • University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus

    Biokatu 10, Tampere, FI-33520

  • Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor

    Helsinki, FI-00100

  • Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor

    Helsinki, FI-00930

  • Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17

    Jarvenpaa, FI-04400

  • Kokkola Vaccine Research Clinic, Rantakatu 7

    Kokkola, FI-67100

  • Kotka Vaccine Research Clinic, Karjalantie 10-12

    Kotka, FI-48600

  • Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188

    Kuopio, 70211

  • Lahti Vaccine Research Clinic, Vesijärvenkatu 74

    Lahti, FI-15140

  • Oulu Vaccine Research Clinic, Kiviharjunlenkki 6

    Oulu, FI-90220

  • Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor)

    Pori, FI-28100

  • Seinäjoki Vaccine Research Clinic, Keskuskatu 6

    Seinäjoki, FI-60100

  • Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor)

    Tampere, FI-33100

  • Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor

    Tapiontori 1, Espoo, FI-02100

  • Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor)

    Turku, FI-20520

  • Vantaa East, Vaccine Research Clinic, Asematie 11 a 16

    Vantaa, FI-01300

  • Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor

    Vantaa, FI-01600

Other trials in Finland

About this study

Official title: A Phase IIIB, Observer-Blind, Randomized, Parallel Groups, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of a Sub-unit Adjuvanted or a Non-adjuvanted Influenza Vaccines in Healthy Children Previously Vaccinated in the V70P5 Study

This study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.

Conditions
Influenza
Being tested
Adjuvanted seasonal influenza vaccine
Keywords
Influenza, Trivalent, Adjuvanted, Vaccine, Children
Medical subject headings
Influenza, Human

What participants receive

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

  • Adjuvanted seasonal influenza vaccineBiological

    Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine

Study groups in NCT01210898
Study groupRoleWhat they receive
Group 1ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 2ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 3ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 4ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 5ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 6ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 7ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 8ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 9ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 10ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 11ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 12ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine
Group 13ExperimentalNot described
Receives: Biological: Adjuvanted seasonal influenza vaccine

What is being measured

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

  1. Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection

    Measured: 22 days post vaccination

  2. Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

    Measured: 22 days post vaccination

  3. Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

    Measured: 22 days post vaccination

  4. Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received

    Measured: 22 days post vaccination

Secondary outcomes (2)

  1. Primary immunogenicity outcomes as per CBER criteria

    Measured: Day 22

  2. Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains

    Measured: Day 22

Timeline

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

  1. First posted29 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2011
  4. Study completionDec 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01210898
Sponsor's protocol ID
V70P5E1
Other IDs
2010-021644-18
Status last verified
Jan 2012
First submitted
28 Sep 2010
Last updated
1 Dec 2016
Results posted
No

Publications

  • Vesikari T, Forsten A, Arora A, Tsai T, Clemens R. Influenza vaccination in children primed with MF59-adjuvanted or non-adjuvanted seasonal influenza vaccine. Hum Vaccin Immunother. 2015;11(8):2102-12. doi: 10.1080/21645515.2015.1044167.

    PubMed 26091244

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvanted seasonal influenza vaccine in people with Influenza, run by Novartis Vaccines at 16 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 1 inclusion and 1 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection (time frame: 22 days post vaccination). The study lists 4 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 NCT01210898, 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 1 Dec 2016.

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