Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season

NCT02381418 | Completed Phase 3 Results

• 1 other identifier: INFL3014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. The current study is a phase III A clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The objective of this study is to investigate the immunogenicity and safety and tolerability of the changed influenza vaccine virus composition in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).

Conditions

Influenza

Keywords

Influenza; Vaccine; Committee for Medicinal Products for Human Use (CHMP) criteria

Outcome Measures

Primary Outcomes (2)

• the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.

  Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.

  3 weeks post vaccination

• the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.

  Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.

  3 weeks post vaccination

Secondary Outcomes (1)

• Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.

  up to 3 weeks post vaccination

Study Arms (1)

1

EXPERIMENTAL

Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "

Biological: Trivalent influenza subunit vaccine Influvac

Interventions

Trivalent influenza subunit vaccine Influvac BIOLOGICAL

"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "

1

Eligibility Criteria

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

You may qualify if:

• Willing and able to give informed consent and able to adhere to all protocol required study procedures.
• Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
• Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator

You may not qualify if:

• Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
• A serious adverse reaction after a previous (influenza) vaccination.
• Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
• A history of Guillain-Barré syndrome or active neurological disease.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Research Facility ID ORG-001075

Maroubra, NSW 2035, Australia

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: Global Clinical Director
• Organization: Abbott

serge.vandewitte@abbott.com

+31294477184

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: March 3, 2015
• First Posted: March 6, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 22, 2016
• Results First Posted: December 22, 2016

Record last verified: 2016-10

Locations

AU (1)