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CompletedNCT00971906Updated Feb 11, 2020

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

A Phase 3 interventional study of Monovalent A/H1N1 influenza vaccine in Pandemic Influenza, sponsored by Novartis Vaccines. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Novartis Vaccines (formerly part of Novartis) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
660
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.

02

Conditions studied

  • Pandemic Influenza

Keywords

  • Pandemic influenza
  • Vaccine
03

In context

Lead sponsor

Novartis Vaccines is the lead sponsor of 165 studies on the registry; none are open to participants now.

First submitted before Novartis Vaccines left Novartis.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and females 18 years of age and above on the day of enrollment;
  2. Individuals in good health
  3. Individuals are able to comply with all study procedures
  4. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion criteria

Exclusion Criteria:

  1. Individual not able to comprehend and to follow all required study procedures;
  2. History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
  3. Any serious chronic or progressive disease according to judgment of the investigator
  4. History of any anaphylaxis, serious vaccine reactions, to any excipients.
  5. Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
  6. Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
  7. Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
  8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
  9. Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
  10. Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
  11. History of progressive or severe neurological disorders;
  12. Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
  13. Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
  14. Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
  15. Members of the research staff or their relatives.
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
660 participants (actual)

Study arms

  • Experimental
    low dose of antigen + low dose of adjuvant

    Biological: Monovalent A/H1N1 influenza vaccine

  • Experimental
    high dose of antigen + high dose of adjuvant

    Biological: Monovalent A/H1N1 influenza vaccine

  • Experimental
    high dose of antigen

    Biological: Monovalent A/H1N1 influenza vaccine

Interventions

  • BiologicalMonovalent A/H1N1 influenza vaccine

    This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen \& adjuvant,or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups

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What researchers measure

Primary outcomes

  1. To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults

    Time frame: 43 days after first vaccination

Secondary outcomes

  1. To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria

    Time frame: 3 weeks after booster vaccination

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Study locations

4 sites
  • Gent, Antwerpen
    Antwerp, Belgium
  • Munchen, Wurzburg, Balve, Leipzig, Magdeburg, Hamburg, Rostock, Mainz
    Mainz, Germany
  • Basel, Switzerland
  • Zurich, Switzerland
08

References and documents

Publications

  • Hatz C, von Sonnenburg F, Casula D, Lattanzi M, Leroux-Roels G. A randomized clinical trial to identify the optimal antigen and MF59((R)) adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects. Vaccine. 2012 May 14;30(23):3470-7. doi: 10.1016/j.vaccine.2012.03.017. Epub 2012 Mar 22. PubMed 22446638 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2009, a primary completion of Oct 2009 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2009
First posted
Sep 4, 2009
Start
Aug 2009
Primary completionActual
Oct 2009
CompletionActual
Apr 2011
Last update
Feb 11, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00971906
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Sep 4, 2009
Start date
Aug 2009
Primary completion
Oct 2009
Completion
Apr 2011
Last update
Feb 11, 2020
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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