NCT00973700 is a Phase 3 clinical trial of MF59-eH1N1_f in Novel 2009 Influenza H1N1, sponsored by Novartis Vaccines.

Who is sponsoring NCT00973700?

NCT00973700 is sponsored by Novartis Vaccines.

What drugs are being tested in NCT00973700?

Interventions in NCT00973700: MF59-eH1N1_f, eH1N1_f.

What condition does NCT00973700 study?

NCT00973700 studies Novel 2009 Influenza H1N1.

Is NCT00973700 still recruiting?

NCT00973700 is currently completed. Last updated 29 October 2015.

Are results published for NCT00973700?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-10-29 · How we verify

NCT00973700

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

A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years

Completed Phase 3 Results posted Last updated 29 October 2015

What this trial tests

Phase 3 trial testing MF59-eH1N1_f in Novel 2009 Influenza H1N1 in 784 participants. Completed in 1 October 2010.

Timeline

1 August 2009

Primary endpoint
1 October 2009

1 October 2010

Quick facts

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	784
Start date	1 August 2009
Primary completion	1 October 2009
Estimated completion	1 October 2010
Sites	1 location across Costa Rica

Drugs / interventions tested

MF59-eH1N1_f — full drug profile →
eH1N1_f — full drug profile →

Conditions studied

Novel 2009 Influenza H1N1 — all drugs for Novel 2009 Influenza H1N1 →

Sponsor

Novartis Vaccines — full company profile →

Who can join

Adults 3 to 64, any sex, with Novel 2009 Influenza H1N1. Healthy volunteers can join.

What's being measured

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

Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Time frame: Day 1 to day 387
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Time frame: Day 1 to day 387
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).

Sponsor's own description

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

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:

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 NCT00973700 (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: 29 October 2015

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/NCT00973700.

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