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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01746082
The ClinicalTrials.gov registry entry for NCT01746082 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Influenza A/H3N2 variant Vaccine is the first listed.
NCT01746082 reports 0 study locations.
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.
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