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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00958126
First received: August 12, 2009
Last updated: August 31, 2012
Last verified: August 2012
Results First Received: July 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: CSL425
Biological: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo, Adults Vaccine diluent; Adults aged 18 to 64 years
CSL425 (7.5 Mcg), Adults 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
CSL425 (15 Mcg), Adults 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
CSL425 (30 Mcg), Adults 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Placebo, Older Adults Vaccine diluent; Older adults aged 65 years or older
CSL425 (7.5 Mcg), Older Adults 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
CSL425 (15 Mcg), Older Adults 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
CSL425 (30 Mcg), Older Adults 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older

Participant Flow:   Overall Study
    Placebo, Adults     CSL425 (7.5 Mcg), Adults     CSL425 (15 Mcg), Adults     CSL425 (30 Mcg), Adults     Placebo, Older Adults     CSL425 (7.5 Mcg), Older Adults     CSL425 (15 Mcg), Older Adults     CSL425 (30 Mcg), Older Adults  
STARTED     49     205     201     203     50     203     200     202  
COMPLETED     48     196     191     192     50     202     199     202  
NOT COMPLETED     1     9     10     11     0     1     1     0  
Serious Adverse Event                 0                 2                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 0                 2                 0                 0                 0                 0                 0                 0  
Moved away from study area                 0                 0                 1                 1                 0                 0                 0                 0  
Lost to Follow-up                 1                 5                 9                 8                 0                 0                 0                 0  
Sponsor/Investigator decision                 0                 0                 0                 1                 0                 0                 0                 0  
Other Reason                 0                 0                 0                 1                 0                 1                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo, Adults Vaccine diluent; Adults aged 18 to 64 years
CSL425 (7.5 Mcg), Adults 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
CSL425 (15 Mcg), Adults 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
CSL425 (30 Mcg), Adults 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
Placebo, Older Adults Vaccine diluent; Older adults aged 65 years or older
CSL425 (7.5 Mcg), Older Adults 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
CSL425 (15 Mcg), Older Adults 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
CSL425 (30 Mcg), Older Adults 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
Total Total of all reporting groups

Baseline Measures
    Placebo, Adults     CSL425 (7.5 Mcg), Adults     CSL425 (15 Mcg), Adults     CSL425 (30 Mcg), Adults     Placebo, Older Adults     CSL425 (7.5 Mcg), Older Adults     CSL425 (15 Mcg), Older Adults     CSL425 (30 Mcg), Older Adults     Total  
Number of Participants  
[units: participants]
  49     205     201     203     50     203     200     202     1313  
Age, Customized  
[units: participants]
                 
>= 18 years to 64 years     49     205     201     203     0     0     0     0     658  
>=65 years     0     0     0     0     50     203     200     202     655  
Gender  
[units: participants]
                 
Female     31     123     113     113     29     120     108     112     749  
Male     18     82     88     90     21     83     92     90     564  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seroconversion Rate 21 Days After the First Vaccination   [ Time Frame: 21 days after the first vaccination ]

2.  Primary:   Seroconversion Rate 21 Days After the Second Vaccination   [ Time Frame: 21 days after the second vaccination ]

3.  Primary:   Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination   [ Time Frame: 21 days after the first vaccination ]

4.  Primary:   Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination   [ Time Frame: 21 days after the second vaccination ]

5.  Secondary:   Frequency and Intensity of Solicited Adverse Events After the First Vaccination   [ Time Frame: During the 7 days after the first vaccination ]

6.  Secondary:   Duration of Solicited Local Adverse Events After the First Vaccination   [ Time Frame: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs ]

7.  Secondary:   Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)   [ Time Frame: Up to 180 days after the last vaccination ]

8.  Secondary:   Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination   [ Time Frame: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Clinical Trials Disclosure Manager
Organization: CSL Limited
phone: Use email contact
e-mail: csl.clinicaltrials@csl.com.au


Publications of Results:

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00958126     History of Changes
Other Study ID Numbers: CSLCT-CAL-09-61
Study First Received: August 12, 2009
Results First Received: July 5, 2012
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration