A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults

NCT00938639 | Completed Phase 2 Results DMC

• 1 other identifier: CSLCT-CAL-09-59
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.

Conditions

Influenza Caused by the Novel Influenza A (H1N1) Virus

Outcome Measures

Primary Outcomes (6)

• Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination

  Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

  Before and 21 days after the first vaccination

• HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination

  Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

  Before and 21 days after the second vaccination

• Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination

  GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

  Before and 21 days after the first vaccination

• GMFI in the HI and MN Antibody Titer After the Second Vaccination

  GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

  Before and 21 days after the second vaccination

• Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination

  21 days after the first vaccination

• Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination

  21 days after the second vaccination

Secondary Outcomes (20)

• HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group

  Before and 21 days after the first vaccination

• HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group

  Before and 21 days after the second vaccination

• GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group

  Before and 21 days after the first vaccination

• GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group

  Before and 21 days after the second vaccination

• Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group

  21 days after the first vaccination

Study Arms (2)

CSL425 (15 mcg)

EXPERIMENTAL

15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Biological: CSL425

CSL425 (30 mcg)

EXPERIMENTAL

30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Biological: CSL425

Interventions

CSL425 BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

CSL425 (15 mcg)

Eligibility Criteria

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

You may qualify if:

• Male or female aged \>= 18 to \< 65 years at the time of providing informed consent.

You may not qualify if:

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (1)

Study Site

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

• Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.

  PMID: 19745216 RESULT

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

1-855-358-8966

Study Officials

• Director, Vaccines Clinical Development

  Seqirus

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 28, 2018
• Results First Posted: November 21, 2013

Record last verified: 2018-04

Locations

AU (1)