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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CSL Limited

ClinicalTrials.gov Identifier:

NCT00958243

First received: August 12, 2009

Last updated: February 10, 2012

Last verified: August 2011

History of Changes

Results First Received: July 13, 2011

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: CSL's 2009 H1N1 Influenza Vaccine (CSL425) Biological: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo Cohort A	Placebo, Aged 6 months to less than 3 years
CSL425 (7.5 Mcg) Cohort A	7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
CSL425 (15 Mcg) Cohort A	15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
Placebo Cohort B	Placebo, Aged 3 years to less than 9 years
CSL425 (7.5 Mcg) Cohort B	7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
CSL425 (15 Mcg) Cohort B	15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years

Participant Flow: Overall Study

	Placebo Cohort A	CSL425 (7.5 Mcg) Cohort A	CSL425 (15 Mcg) Cohort A	Placebo Cohort B	CSL425 (7.5 Mcg) Cohort B	CSL425 (15 Mcg) Cohort B
STARTED	26	105	96	28	109	109
COMPLETED	24	99	82	25	100	99
NOT COMPLETED	2	6	14	3	9	10
Withdrawal by Subject	0	1	3	1	1	5
Lost to Follow-up	2	5	11	2	8	5

Baseline Characteristics

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Reporting Groups

	Description
Placebo Cohort A	Placebo, Aged 6 months to less than 3 years
CSL425 (7.5 Mcg) Cohort A	7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
CSL425 (15 Mcg) Cohort A	15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
Placebo Cohort B	Placebo, Aged 3 years to less than 9 years
CSL425 (7.5 Mcg) Cohort B	7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
CSL425 (15 Mcg) Cohort B	15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
Total	Total of all reporting groups

Baseline Measures

	Placebo Cohort A	CSL425 (7.5 Mcg) Cohort A	CSL425 (15 Mcg) Cohort A	Placebo Cohort B	CSL425 (7.5 Mcg) Cohort B	CSL425 (15 Mcg) Cohort B	Total
Number of Participants [units: participants]	26	105	96	28	109	109	473
Age [units: participants]
<=18 years	26	105	96	28	109	109	473
Between 18 and 65 years	0	0	0	0	0	0	0
>=65 years	0	0	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	1.87 ± 0.77	1.73 ± 0.72	1.85 ± 0.66	5.90 ± 1.71	5.94 ± 1.71	5.91 ± 1.70	3.93 ± 2.45
Gender [units: participants]
Female	11	57	44	13	53	50	228
Male	15	48	52	15	56	59	245
Region of Enrollment [units: participants]
United States	26	105	96	28	109	109	473

Outcome Measures

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1. Primary:

Seroconversion Rate 21 Days After First Study Vaccination [ Time Frame: 21 days after the first study vaccination ]

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2. Primary:

Seroconversion Rate 21 Days After Second Study Vaccination [ Time Frame: 21 days after the second study vaccination ]

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Measure Type	Primary
Measure Title	Seroconversion Rate 21 Days After Second Study Vaccination
Measure Description	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.
Time Frame	21 days after the second study vaccination
Safety Issue	No

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.
The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).

Reporting Groups

	Description
Placebo Cohort A	Placebo, Aged 6 months to less than 3 years
CSL425 (7.5 Mcg) Cohort A	7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
CSL425 (15 Mcg) Cohort A	15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
Placebo Cohort B	Placebo, Aged 3 years to less than 9 years
CSL425 (7.5 Mcg) Cohort B	7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
CSL425 (15 Mcg) Cohort B	15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years

Measured Values

	Placebo Cohort A	CSL425 (7.5 Mcg) Cohort A	CSL425 (15 Mcg) Cohort A	Placebo Cohort B	CSL425 (7.5 Mcg) Cohort B	CSL425 (15 Mcg) Cohort B
Number of Participants Analyzed [units: participants]	21	90	80	26	98	98
Seroconversion Rate 21 Days After Second Study Vaccination [units: Percentage of participants] Number ( 95% Confidence Interval )	28.6 ( 11.3 to 52.2 )	98.9 ( 94.0 to 100.0 )	100.0 ( 95.5 to 100.0 )	15.4 ( 4.4 to 34.9 )	98.0 ( 92.8 to 99.8 )	99.0 ( 94.4 to 100.0 )

No statistical analysis provided for Seroconversion Rate 21 Days After Second Study Vaccination

3. Primary:

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

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4. Primary:

Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination [ Time Frame: 21 days after the second study vaccination ]

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5. Secondary:

Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A [ Time Frame: During the 7 days after each study vaccination ]

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6. Secondary:

Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A [ Time Frame: During the 7 days after each study vaccination ]

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7. Secondary:

Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B [ Time Frame: During the 7 days after each study vaccination ]

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8. Secondary:

Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B [ Time Frame: During the 7 days after each study vaccination ]

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9. Secondary:

Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination [ Time Frame: During the 21 days after each vaccination ]

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10. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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
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Results Point of Contact:

Name/Title: Dr Russell Basser
Organization: CSL Limited
phone: 61393891569
e-mail: russell.basser@csl.com.au

No publications provided

Responsible Party:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00958243 History of Changes
Other Study ID Numbers:	CSLCT-CAL-09-62
Study First Received:	August 12, 2009
Results First Received:	July 13, 2011
Last Updated:	February 10, 2012
Health Authority:	United States: Food and Drug Administration

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