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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024613-31 | EudraCT Number |
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This study will evaluate safety and immunogenicity of surface, antigen, inactivated, influenza vaccine produced in mammalian cell culture when administered to adult and elderly subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cell culture derived TIV | Experimental | single dose of cell culture derived seasonal trivalent influenza vaccine (TIV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seasonal influenza vaccine | Biological | Subjects received one single IM dose of trivalent Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture during the vaccination visit, according to the study protocol (follow-up period: until day 22) . |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody response as measured by hemagglutination inhibition (HI) assay | Antibody response to each influenza antigen as measured by hemagglutination inhibition (HI) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody response as measured by single radial hemolysis (SRH) assay | Antibody response to each influenza antigen as measured by single radial hemolysis (SRH) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines | 22 days |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
Individuals with any serious chronic or acute disease including but not limited to: Medically significant Cancer , Medically significant advanced congestive heart failure (ie. NYHA class III and IV),Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years);Diabetes mellitus type I/II ;Advanced arteriosclerotic disease ;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological or psychiatric disorder; Severe asthma
Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination
Individuals with known or suspected impairment/alteration of immune function resulting, for example, from:
receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of immunostimulants; receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
Individuals with known or suspected history of drug or alcohol abuse
Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential not planning to use acceptable birth control measures, for the whole duration of the study
Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
Individuals who within the past 6 months have had any seasonal or pandemic laboratory confirmed influenza disease
Individuals who have received any seasonal or pandemic influenza vaccine;
Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
Individuals who have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days of intended study vaccination
Individuals participating in another clinical trial
Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study
Individuals who are part of study personnel or close family members conducting this study
BMI > 35 kg/m2
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Reisinger | Universität Rostock / Medizinische Fakultät | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Rostock / Medizinische Fakultät | Rostock | 18057 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23976960 | Derived | Loebermann M, Voss U, Meyer S, Bosse D, Fritzsche C, Klammt S, Frimmel S, Riebold D, Reisinger EC. Clinical trial to evaluate the safety and immunogenicity of a trivalent surface antigen seasonal influenza vaccine produced in mammalian cell culture and administered to young and elderly adults with and without A(H1N1) pre-vaccination. PLoS One. 2013 Aug 16;8(8):e70866. doi: 10.1371/journal.pone.0070866. eCollection 2013. |
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| Number of subjects with solicited local and systemic reactions | To evaluate the safety of a single intramuscular (IM) injection of Optaflu in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96) | 7 days post vaccination |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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