Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
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ClinicalTrials.gov Identifier: NCT01229397 |
Recruitment Status :
Completed
First Posted : October 27, 2010
Results First Posted : May 20, 2013
Last Update Posted : February 6, 2014
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Sponsor:
Crucell Holland BV
Information provided by (Responsible Party):
Crucell Holland BV
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Condition |
Influenza |
Intervention |
Biological: Inflexal V |
Enrollment | 205 |
Participant Flow
Recruitment Details | Recruitment period: 05 October - 17 January 2011; Location: University of Milan |
Pre-assignment Details |
Arm/Group Title | Inflexal V 0.25 mL x 2 | Inflexal V 0.5 mL x 1 |
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2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:
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1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:
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Period Title: Overall Study | ||
Started | 103 | 102 |
Completed | 92 | 93 |
Not Completed | 11 | 9 |
Reason Not Completed | ||
Withdrawal by Subject | 3 | 3 |
Lost to Follow-up | 7 | 6 |
Migrated/moved from study area | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Inflexal V 0.25 mL x 2 | Inflexal V 0.5 mL x 1 | Total | |
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Two 0.25 mL doses (on Day 1 and 29) | One 0.5 mL dose (on Day 1) | Total of all reporting groups | |
Overall Number of Baseline Participants | 103 | 102 | 205 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 103 participants | 102 participants | 205 participants | |
<=18 years |
103 100.0%
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102 100.0%
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205 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 103 participants | 102 participants | 205 participants | |
1.8 (0.52) | 1.8 (0.61) | 1.8 (0.57) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 103 participants | 102 participants | 205 participants | |
Female |
37 35.9%
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37 36.3%
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74 36.1%
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Male |
66 64.1%
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65 63.7%
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131 63.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Italy | Number Analyzed | 103 participants | 102 participants | 205 participants |
103 | 102 | 205 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 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 at least 60 days from the time submitted to the sponsor for review. The sponsor reserves the right to remove any proprietary or confidential information and to require that publication be delayed for up to 60 additional days to enable the sponsor to prepare and file patent applications.
Results Point of Contact
Name/Title: | Medical Affairs Director |
Organization: | Crucell Switzerland AG |
Phone: | +41(0)319806111 |
EMail: | info@crucell.com |
Responsible Party: | Crucell Holland BV |
ClinicalTrials.gov Identifier: | NCT01229397 |
Other Study ID Numbers: |
INF-V-A005 |
First Submitted: | October 22, 2010 |
First Posted: | October 27, 2010 |
Results First Submitted: | October 23, 2012 |
Results First Posted: | May 20, 2013 |
Last Update Posted: | February 6, 2014 |