Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

NCT01636102 | Completed Phase 2 Results

• 2 other identifiers: V71_32S2012-000063-24
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated influenza study vaccine, formulation 2012/2013, in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization 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.

Conditions

Human Influenza

Keywords

Influenza; Adults; Elderly; Immunology; Safety

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV

  Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area 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 TIV

  Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), 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 SRH antibody area is \>2.5 (≥18 years to ≤60 years) or \>2.0 (≥61 years).

  Day 22

• Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV

  Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22). This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 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)

Arm 1

EXPERIMENTAL

Biological: Trivalent influenza virus vaccine (TIV)

Interventions

Trivalent influenza virus vaccine (TIV) BIOLOGICAL

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

Arm 1

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;
• 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, 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 (ie. 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 Hospital Ghent, Center for Vaccinology, Prof.Dr. G Leroux Roels

Ghent, Ghent, BC001, Belgium

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
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 30, 2015
• Results First Posted: January 29, 2014

Record last verified: 2015-11

Locations

BE (1)