Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults Aged 18 Years and Above

NCT01640327 | Completed Phase 3 Results

• 2 other identifiers: V78_10S2011-006271-18
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety and immunogenicity data, in compliance to current EU Guidelines, with the intent of obtaining marketing approval of the vaccine formulation intended for use prior to the next influenza season in the Northern Hemisphere. The antibody response to each influenza vaccine antigen, was measured by hemagglutination inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM) injection of the vaccine was evaluated in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96).

Conditions

Human; Influenza

Keywords

Interpandemic influenza; Adult; Elderly; Safety; Tolerability; Immunology

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVf

  Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI antigen assay. As per the European (CHMP) criteria seroconversion or significant increase in titer was defined as the percentage of subjects with a prevaccination HI titer \<10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion was met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is \>40% (≥18 years to ≤60 years) or \>30% (≥61 years).

  Day 22

• Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVf

  Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer was \>2.5 (≥18 years to ≤60 years) or \>2.0 (≥61 years).

  Day 22

• Percentage of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVf

  Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVf vaccination (day 22). This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is \>70% (≥18 years to ≤60) or \>60% (≥61 years).

  Day 1 and 22

Secondary Outcomes (1)

• Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)

  From day 1 through day 4 postvaccination

Study Arms (1)

TIVf

EXPERIMENTAL

Biological: Trivalent influenza virus vaccine (TIVf)

Interventions

Trivalent influenza virus vaccine (TIVf) BIOLOGICAL

A single dose (0.5 mL) of vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm

TIVf

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 or older, mentally competent, were willing and gave written informed consent prior to study entry;
• Individuals who complied 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, could have interfered 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:
• Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment);
• Medically significant advanced congestive heart failure (i.e., NYHA class III and IV);
• Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV);
• Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥5 years);
• Diabetes mellitus type I;
• Poorly controlled diabetes mellitus type 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 (es. Guillain-Barré syndrome) 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 eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate).

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

University of Rostock, Department Tropical Medicine and Infectious Diseases

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 24, 2015
• Results First Posted: January 29, 2014

Record last verified: 2015-10

Locations

DE (1)