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

NCT00940108 | Completed Phase 2 Results DMC

• 1 other identifier: CSLCT-CAL-09-60
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Influenza Caused by the Novel Influenza A (H1N1) Virus

Outcome Measures

Primary Outcomes (6)

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

  HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI 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 Antibody Titre Seroconversion Rate After the Second Vaccination

  HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI 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 Antibody Titre After the First Vaccination

  GMFI in HI 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 Antibody Titre After the Second Vaccination

  GMFI in HI 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 Antibody Titre of 1:40 or More After the First Vaccination

  21 days after the first vaccination

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

  21 days after the second vaccination

Secondary Outcomes (5)

• Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination

  During the 7 days after each vaccination

• Duration of Solicited AEs After the First Vaccination

  During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.

• Duration of Solicited AEs After the Second Vaccination

  During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.

• Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)

  Up to 180 days after the last vaccination

• Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination

  During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

Study Arms (2)

CSL425 (15 mcg)

EXPERIMENTAL

15 mcg of hemagglutinin 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 hemagglutinin 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-free

CSL425 (15 mcg)

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female aged \>= 6 months to \< 9 years at the time of the first study vaccination.
• For children \< 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.

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 (5)

Study Site

Westmead, New South Wales, 2145, Australia

Location

Study Site

Brisbane, Queensland, 4006, Australia

Location

Study Site

North Adelaide, South Australia, 5006, Australia

Location

Study Site

Carlton, Victoria, 3010, Australia

Location

Study Site

Subiaco, Western Australia, 6027, Australia

Location

Related Publications (1)

• Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.

  PMID: 20026597 RESULT

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Clinical Study Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

1-855-358-8966

Study Officials

• Clinical Director Vaccines

  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 15, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: April 1, 2010
• Last Updated: June 28, 2018
• Results First Posted: November 20, 2013

Record last verified: 2018-04

Locations

AU (5)