CClinicalTrials.gg
Sign In
CompletedNCT01101074Updated Oct 12, 2011

Observational Safety and Effectiveness Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

An observational study in Influenza A (H1N1), sponsored by Novartis Vaccines. Completed at 1 site in Italy. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-12.

Sponsored by Novartis Vaccines · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
135,469
Ages
6 Months and older
Sex
All
01

Study summary

This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.

02

Conditions studied

  • Influenza A (H1N1)

Browse trials for

Keywords

  • Swine Flu A (H1N1) vaccine
  • Adjuvanted flu egg derived
  • Novel influenza A (H1N1): a new flu virus of swine origin
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 135,469 is above the median of 300 across 305 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Population of children, adolescents, adults and elderly

Inclusion criteria

  • Subjects resident in Emilia-Romagna and either registered with the AUSL of Reggio Emilia, Bologna, Modena and Parma or working in the province of Reggio Emilia, Bologna, Modena and Parma included in the target groups described in the Study Protocol vaccination with H1N1sw vaccine Focetria is recommended - according to the national pandemic plan adopted at the local level - will be eligible for enrolment.

Exclusion criteria

Exclusion Criteria:

  • Subjects already vaccinated with another pandemic vaccine or with known contraindications to Focetria, will be excluded from this study.
  • Patients institutionalized in Hospital, Nursing Homes, Rehabilitation Centers, as well as home-cared patients, will also be excluded.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
135,469 participants (actual)

Groups and cohorts

  • 6-23 months

    Other: This is non-intervention observational study

  • 2-8 years

    Other: This is non-intervention observational study

  • 9-17 years

    Other: This is non-intervention observational study

  • 18-44 years

    Other: This is non-intervention observational study

  • 45-60 years

    Other: This is non-intervention observational study

  • >60 years

    Other: This is non-intervention observational study

Interventions

  • OtherThis is non-intervention observational study

    This is non-intervention observational study

06

What researchers measure

Primary outcomes

  1. Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects

    Time frame: Within 3 weeks and 6 weeks after vaccine administration

Secondary outcomes

  1. The occurrence of hospitalization within 6 weeks and 2 years after vaccination in a cohort of subjects vaccinated sw unvaccinated subjects, with Flu Egg Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine

    Time frame: 2 years

07

Study locations

1 site
  • Emilia Romagna, Italy
08

References and documents

Publications

  • Moro ML, Nobilio L, Voci C, Di Mario S, Candela S, Magrini N; SaFoH1N1 working group. A population based cohort study to assess the safety of pandemic influenza vaccine Focetria in Emilia-Romagna region, Italy - part two. Vaccine. 2013 Feb 27;31(10):1438-46. doi: 10.1016/j.vaccine.2012.07.090. Epub 2012 Aug 10. PubMed 22885015 ↗
  • Candela S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, Magrini N; SaFoH1N1 working group. An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one. Vaccine. 2013 Feb 27;31(10):1431-7. doi: 10.1016/j.vaccine.2012.06.030. Epub 2012 Jul 2. PubMed 22766247 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01101074
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Apr 9, 2010
Start date
Oct 2009
Primary completion
Jan 2010
Completion
Sep 2010
Last update
Oct 12, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Other studies in this condition

Influenza, Human→

Other studies from this sponsor

Novartis Vaccines

Start the discussion