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NCT00973349 · ClinicalTrials.gov registry record · Phase 2

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

A Phase 2 study, sponsored by Novartis.

Completed
Registry status
Phase 2
Development phase
2,719
Enrollment target

NCT00973349: Completed Phase 2 study, sponsored by Novartis.

NCT00973349 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 2,719 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1944% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00973349, a Phase 2 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 2
Development phase
2,719 participants
Enrollment target

Study Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Primary Outcome

Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.

Interventions

  • BIOLOGICAL MF59-eH1N1_f

Trial Details

FieldValue
Enrollment Target 2,719 participants
Start Date 2009-09
Est. Completion 2010-12
Phase Phase 2
Novartis

265 total trials

What the finished NCT00973349 record still lists

NCT00973349 is an interventional study that assigns participants to a tested intervention. Its 2,719 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1944% higher).

The record links to 0 conditions, and to 1 intervention - of which MF59-eH1N1_f is the first listed.

NCT00973349 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00973349 about?

NCT00973349 is a clinical study titled "Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults". This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

What is the current status of trial NCT00973349?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,719 participants. The study started on 2009-09. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00973349?

The interventions under investigation include: MF59-eH1N1_f (BIOLOGICAL).

Who is sponsoring clinical trial NCT00973349?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00973349's enrollment target sits among peer trials

2,719 7th of 2000 higher than 1,994 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00973349, the US trial registry maintained by the National Library of Medicine. NCT00973349 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.