Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
2 other identifiers
interventional
125
1 country
6
Brief Summary
This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 7, 2011
December 1, 2011
Same day
May 5, 2011
December 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
22 days including follow-up period
Study Arms (1)
1
OTHERNo comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Interventions
This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
Eligibility Criteria
You may qualify if:
- Healthy, adult and elderly volunteers over 18 years
You may not qualify if:
- Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via Dei Vestini, Cheiti, 66100, Italy
Dipartimento di Scienze della Salute Università di Genova
Via Pastore, Genova, 16132, Italy
Distretto Sanitario di Base di Fossacesia
Via Polidoro-Vasto, Lanciano, Italy
ASL Lanciano - Vasto,
Via S. Spaventa, Lanciano, 66034, Italy
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute
Via Stamira d'Ancona, Milano, 20127, Italy
Dipartimento di malattie infettive Ospedale San Gerardo
Via Pergolesi 33, Monza, 20052, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2011
First Posted
May 20, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
December 7, 2011
Record last verified: 2011-12