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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Tracking Information | |||||||
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First Submitted Date ICMJE | October 22, 2010 | ||||||
First Posted Date ICMJE | October 27, 2010 | ||||||
Results First Submitted Date ICMJE | October 23, 2012 | ||||||
Results First Posted Date ICMJE | May 20, 2013 | ||||||
Last Update Posted Date | February 6, 2014 | ||||||
Study Start Date ICMJE | October 2010 | ||||||
Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regimen of Inflexal V,using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference [ Time Frame: This assesment will be done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary ] | ||||||
Original Secondary Outcome Measures ICMJE |
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability [ Time Frame: This assesment will be done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ] | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V | ||||||
Official Title ICMJE | A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule | ||||||
Brief Summary | The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Influenza | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
205 | ||||||
Original Estimated Enrollment ICMJE |
240 | ||||||
Actual Study Completion Date ICMJE | November 2010 | ||||||
Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Months to 35 Months (Child) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Italy | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01229397 | ||||||
Other Study ID Numbers ICMJE | INF-V-A005 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Crucell Holland BV | ||||||
Study Sponsor ICMJE | Crucell Holland BV | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Crucell Holland BV | ||||||
Verification Date | August 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |