A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CSL Limited

ClinicalTrials.gov Identifier:

NCT00959049

First received: August 12, 2009

Last updated: August 25, 2011

Last verified: August 2011

History of Changes

Results First Received: July 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Influenza
Interventions:	Biological: CSL's Influenza Virus Vaccine (Afluria) Biological: Influenza Virus Vaccine (Fluzone)

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
Participants were enrolled into this study during the autumn of 2009 at 23 sites in the US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1474 participants were enrolled, vaccinated and analyzed.

Reporting Groups

	Description
Afluria Cohort A	Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort B	Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort C	Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Fluzone Cohort A	Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort B	Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort C	Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.

Participant Flow: Overall Study

	Afluria Cohort A	Afluria Cohort B	Afluria Cohort C	Fluzone Cohort A	Fluzone Cohort B	Fluzone Cohort C
STARTED	231	254	254	228	257	250
COMPLETED	213	247	253	217	248	249
NOT COMPLETED	18	7	1	11	9	1
Adverse Event	1	0	0	0	0	0
Lost to Follow-up	17	5	1	10	9	1
Contraindicated medication	0	0	0	1	0	0
Withdrawal by Subject	0	2	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Afluria Cohort A	Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort B	Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Afluria Cohort C	Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
Fluzone Cohort A	Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort B	Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Fluzone Cohort C	Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
Total	Total of all reporting groups

Baseline Measures

	Afluria Cohort A	Afluria Cohort B	Afluria Cohort C	Fluzone Cohort A	Fluzone Cohort B	Fluzone Cohort C	Total
Number of Participants [units: participants]	231	254	254	228	257	250	1474
Age [units: participants]
<=18 years	231	254	254	228	257	250	1474
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	1.94 ± 0.667	5.93 ± 1.725	12.98 ± 2.388	1.96 ± 0.673	5.82 ± 1.748	12.86 ± 2.474	7.06 ± 4.855
Gender [units: participants]
Female	119	140	121	101	127	120	728
Male	112	114	133	127	130	130	746
Region of Enrollment [units: participants]
United States	231	254	254	228	257	250	1474

Outcome Measures

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1. Primary:

Geometric Mean Titer 30 Days After the Last Study Vaccination [ Time Frame: 30 days after the last study vaccination ]

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2. Primary:

Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination [ Time Frame: 30 days after the last study vaccination ]

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3. Secondary:

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) [ Time Frame: 7 days after each vaccination ]

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4. Secondary:

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B [ Time Frame: 7 days after each vaccination ]

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5. Secondary:

Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C [ Time Frame: 7 days after vaccination ]

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6. Secondary:

Frequency and Intensity of Unsolicited Adverse Events (UAEs) [ Time Frame: 30 days after each vaccination ]

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7. Secondary:

New Onset of Chronic Illnesses (NOCIs) [ Time Frame: 6 months after last study vaccination ]

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8. Secondary:

Serious Adverse Events (SAEs) [ Time Frame: 6 months after last study vaccination ]

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9. Secondary:

Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) [ Time Frame: 7 days after each vaccination ]

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10. Secondary:

Duration of Local and Systemic Solicited Symptoms, Cohort B [ Time Frame: 7 days after each vaccination ]

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11. Secondary:

Duration of Local and Systemic Solicited Symptoms, Cohort C [ Time Frame: 7 days after vaccination ]

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Serious Adverse Events

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Other Adverse Events

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