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
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.
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.
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.
Exclusion Criteria:
Biological: Monovalent A/H1N1 influenza vaccine
Biological: Monovalent A/H1N1 influenza vaccine
Biological: Monovalent 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
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
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
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.
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.