Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01357265
First received: May 5, 2011
Last updated: December 6, 2011
Last verified: December 2011
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 5, 2011 |
| Last Updated Date | December 6, 2011 |
| Start Date ICMJE | May 2011 |
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly [ Time Frame: 22 days including follow-up period ] [ Designated as safety issue: Yes ] 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. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01357265 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects |
| Official Title ICMJE | 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 |
| Brief Summary | This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Condition ICMJE | Influenza |
| Intervention ICMJE | Biological: Seasonal Influenza Vaccine
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) . |
| Study Arm (s) | 1
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Intervention: Biological: Seasonal Influenza Vaccine |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 125 |
| Completion Date | June 2011 |
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria: Healthy, adult and elderly volunteers over 18 years Exclusion Criteria: Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Italy |
| Administrative Information | |
| NCT Number ICMJE | NCT01357265 |
| Other Study ID Numbers ICMJE | V71_27S, 2010-024400-98 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Novartis ( Novartis Vaccines ) |
| Study Sponsor ICMJE | Novartis Vaccines |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Novartis |
| Verification Date | December 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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