NCT00958126

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 adults

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,313

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

October 3, 2012

Completed
Last Updated

November 21, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

August 12, 2009

Results QC Date

July 5, 2012

Last Update Submit

October 18, 2017

Conditions

Influenza

Outcome Measures

Primary Outcomes (4)

  • Seroconversion Rate 21 Days After the First Vaccination

    Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.

    21 days after the first vaccination

  • Seroconversion Rate 21 Days After the Second Vaccination

    Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.

    21 days after the second vaccination

  • Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination

    21 days after the first vaccination

  • Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination

    21 days after the second vaccination

Secondary Outcomes (4)

  • Frequency and Intensity of Solicited Adverse Events After the First Vaccination

    During the 7 days after the first vaccination

  • Duration of Solicited Local Adverse Events After the First Vaccination

    During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs

  • Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)

    Up to 180 days after the last vaccination

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

    Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

Study Arms (4)

CSL425 (7.5 mcg)

EXPERIMENTAL

7.5 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 (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

Placebo

PLACEBO COMPARATOR

Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

Biological: Placebo

Interventions

CSL425BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.

CSL425 (7.5 mcg)
PlaceboBIOLOGICAL

Vaccine diluent, thimerosal 0.01% (weight/volume).

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 and older, inclusive, at the time of providing informed consent.
  • Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Study Site

Huntsville, Alabama, 35802, United States

Location

Study Site

San Diego, California, 92108, United States

Location

Study Site

Melbourne, Florida, 32935, United States

Location

Study Site

Peoria, Illinois, 61602, United States

Location

Study Site

South Bend, Indiana, 46601, United States

Location

Study Site

Metairie, Louisiana, 70006, United States

Location

Study Site

Baltimore, Maryland, 21205, United States

Location

Study Site

Rockville, Maryland, 20850, United States

Location

Study Site

Austin, Texas, 78705, United States

Location

Study Site

Fort Worth, Texas, 76135, United States

Location

Study Site

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

  • Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37. doi: 10.1086/656601.

    PMID: 20874515RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Clinical Trials Disclosure Manager
Organization
Seqirus
Seqirus.ClinicalTrials@Seqirus.com

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

August 12, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

April 1, 2010

Last Updated

November 21, 2017

Results First Posted

October 3, 2012

Record last verified: 2017-10

Locations

US(11)