Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

NCT01161264 | Completed Phase 3

• 2 other identifiers: V78_08S2010-019040-39
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).

Conditions

Seasonal Influenza

Keywords

Elderly; Influenza; Immunogenicity; Safety; Influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Antibody response to each influenza vaccine antigen as measured by hemagglutination inhibition at 21 days post immunization

  22 days

Study Arms (2)

18-60 YOA

EXPERIMENTAL

Biological: Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011

≥ 60 YOA

EXPERIMENTAL

Biological: Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011

Interventions

Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011 BIOLOGICAL

Single 0.5 mL dose administered into the deltoid muscle of (preferably) the non-dominant arm on Day 1.

18-60 YOA; ≥ 60 YOA

Eligibility Criteria

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

You may qualify if:

• Male and female volunteers of 18 years of age and 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 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 (in the judgment of the investigator), including but not limited to:
• Cancer, except for localized skin cancer;
• Advanced congestive heart failure;
• Chronic obstructive pulmonary disease (COPD);
• Autoimmune disease (including rheumatoid arthritis);
• 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, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, polymyxin, neomycin);
• Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) 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;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Novartis Investigational Site

Germany, Germany

Location

Related Links

• Results for V78\_08S from the Novartis Clinical Trials website

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Antigens, Surface

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 10, 2021

Record last verified: 2011-09

Locations

DE (1)