Safety and Immunogenicity of One Dose of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture Administered to Adult and Elderly Subjects

NCT01422512 | Completed Phase 3

• 2 other identifiers: V58_25S2010-024613-31
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

seasonal influenza; vaccine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Antibody response as measured by single radial hemolysis (SRH) assay

  22 days

• Number of subjects with solicited local and systemic reactions

  7 days post vaccination

Study Arms (1)

cell culture derived TIV

EXPERIMENTAL

single dose of cell culture derived seasonal trivalent influenza vaccine (TIV)

Biological: seasonal influenza vaccine

Interventions

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) .

Also known as: Optaflu

cell culture derived TIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and female volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry
• Individuals able to comply with all the study requirements
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Universität Rostock / Medizinische Fakultät

Rostock, 18057, Germany

Location

Related Publications (1)

• 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.

  PMID: 23976960 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Prof. Reisinger

  Universität Rostock / Medizinische Fakultät

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 24, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

DE (1)