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NCT01992094 · ClinicalTrials.gov registry record · Phase 3

Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

A Phase 3 study, sponsored by Novartis Vaccines.

Completed
Registry status
Phase 3
Development phase
2,680
Enrollment target

NCT01992094: Completed Phase 3 study, sponsored by Novartis Vaccines.

NCT01992094 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 2,680 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (247% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01992094, a Phase 3 study, has completed, sponsored by Novartis Vaccines.

COMPLETED
Registry status
Phase 3
Development phase
2,680 participants
Enrollment target

Study Summary

Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.

Primary Outcome

Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TI

Interventions

  • BIOLOGICAL QIVc
  • BIOLOGICAL TIV1c
  • BIOLOGICAL TIV2c

Trial Details

FieldValue
Enrollment Target 2,680 participants
Start Date 2013-11
Est. Completion 2014-07
Phase Phase 3
Novartis Vaccines

32 total trials

What the finished NCT01992094 record still lists

NCT01992094 is an interventional study that assigns participants to a tested intervention. Its 2,680 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (247% higher).

The record links to 0 conditions, and to 3 interventions - of which QIVc is the first listed.

NCT01992094 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01992094 about?

NCT01992094 is a clinical study titled "Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older". Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.

What is the current status of trial NCT01992094?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,680 participants. The study started on 2013-11. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01992094?

The interventions under investigation include: QIVc (BIOLOGICAL), TIV1c (BIOLOGICAL), TIV2c (BIOLOGICAL).

Who is sponsoring clinical trial NCT01992094?

This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01992094's enrollment target sits among peer trials

2,680 84th of 2000 higher than 1,917 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01992094, the US trial registry maintained by the National Library of Medicine. NCT01992094 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.