Who is sponsoring NCT01151059?

NCT01151059 is sponsored by Novartis Vaccines.

What drugs are being tested in NCT01151059?

Interventions in NCT01151059: Trivalent subunit inactivated flu vaccine, Formulation 2010-2011.

What condition does NCT01151059 study?

NCT01151059 studies Seasonal Influenza.

Is NCT01151059 still recruiting?

NCT01151059 is currently completed. Last updated 27 March 2012.

Last reviewed 2012-03-27 · How we verify

NCT01151059

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL® S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2010-2011, When Administered to Non-elderly Adult and Elderly Subjects

Completed Phase 2 Last updated 27 March 2012

What this trial tests

Phase 2 trial testing Trivalent subunit inactivated flu vaccine, Formulation 2010-2011 in Seasonal Influenza in 138 participants. Completed in 1 July 2010.

Timeline

1 June 2010

Primary endpoint
1 June 2010

1 July 2010

Quick facts

Lead sponsor	Novartis Vaccines
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	138
Start date	1 June 2010
Primary completion	1 June 2010
Estimated completion	1 July 2010
Sites	5 locations across Italy

Drugs / interventions tested

Trivalent subunit inactivated flu vaccine, Formulation 2010-2011 — full drug profile →

Conditions studied

Seasonal Influenza — all drugs for Seasonal Influenza →

Sponsor

Novartis Vaccines — full company profile →

Who can join

18 and older, any sex, with Seasonal Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in non-elderly adult and elderly subjects
Time frame: 22 days, including the follow-up period

Sponsor's own description

The present study will evaluate the safety and immunogenicity in healthy people (non-elderly adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit inactivated flu vaccine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Seasonal Influenza

Currently open trials in the same condition.

NCT06863142 — Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01151059 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Vaccines
Last refreshed: 27 March 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01151059.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing