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NCT01746082 · ClinicalTrials.gov registry record · Phase 2

Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
211
Enrollment target

NCT01746082: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT01746082 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 211 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01746082, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
211 participants
Enrollment target

Study Summary

This is a Phase II open-label study in approximately 200, and up to 240, healthy males and non-pregnant females, aged 18 years and older. This study is designed to assess the safety, reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by Sanofi Pasteur. Subjects will be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120) subjects \>/= 65 years old) to receive two doses of vaccine, delivered intramuscularly as 15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be approximately 7 months.

Interventions

  • BIOLOGICAL Influenza A/H3N2 variant Vaccine

Trial Details

FieldValue
Enrollment Target 211 participants
Start Date 2013-01
Est. Completion 2013-08
Phase Phase 2

What the finished NCT01746082 record still lists

NCT01746082 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher).

The record links to 0 conditions, and to 1 intervention - of which Influenza A/H3N2 variant Vaccine is the first listed.

NCT01746082 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01746082 about?

NCT01746082 is a clinical study titled "Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations". This is a Phase II open-label study in approximately 200, and up to 240, healthy males and non-pregnant females, aged 18 years and older. This study is designed to assess the safety, reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufa...

What is the current status of trial NCT01746082?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 211 participants. The study started on 2013-01. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01746082?

The interventions under investigation include: Influenza A/H3N2 variant Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01746082?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01746082's enrollment target sits among peer trials

211 290th of 2000 higher than 1,711 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 NCT01746082, the US trial registry maintained by the National Library of Medicine. NCT01746082 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.