A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

NCT01113580 | Completed Phase 4 Results

• 2 other identifiers: CSLCT-ASU-10-662010-019532-12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.

  As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.

  Approximately 21 days after vaccination

• The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.

  GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.

  Approximately 21 days after vaccination

• The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.

  Approximately 21 days after vaccination

Secondary Outcomes (2)

• Frequency of Any Solicited Adverse Events (AEs)

  During the 4 days after vaccination (Day 0 plus 3 days)

• Frequency and Intensity of Any Unsolicited Adverse Events

  After vaccination until the end of the study; approximately 21 days

Study Arms (2)

Adults

EXPERIMENTAL

Healthy volunteers aged 18 to 59 years

Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine

Older Adults

EXPERIMENTAL

Healthy volunteers aged 60 years or older

Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine

Interventions

CSL's 2010/2011 Formulation of Enzira® Vaccine BIOLOGICAL

45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0

Adults; Older Adults

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18 years and older at the time of the first study vaccination.

You may not qualify if:

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
• Clinical signs of an active infection
• Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry
• Females who are pregnant or lactating

Sponsors & Collaborators

• Seqirus: lead

Study Sites (1)

Chiltern (Early Phase) Limited

Dundee, Angus and Dundee, DD1 9SY, United Kingdom

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: Clinical Study Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

Study Officials

• Ronnie Beboso, Dr

  Chiltern (Early Phase) Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 30, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 21, 2017
• Results First Posted: July 18, 2012

Record last verified: 2017-10

Locations

GB (1)