NCT01049490|Completed
Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device
Safety and Efficacy of Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination With the Novel Microneedle Delivery Device
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Safety and Efficacy of Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination With the Novel Microneedle Delivery Device
Sponsor study identifier
interventional
262
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Primary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1 vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the full-dose standard IM injection. Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular (IM) vaccine.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 12, 2010
Actual (reported)January 14, 2010
Actual (reported)June 2010
Actual (reported)June 2010
Actual (reported)Seroconversion rate on day 21 as measured by S-OIV H1N1 specific neutralizing antibody (NT) and hemagglutination inhibition (HAI) in the intradermal (ID) and intramuscular (IM) groups
Day 21
Seroconversion rate day 42
Day 21 and 42
Geometric mean titer increases in antibodies
Day 21 and 42
Specific neutralizing antibody (NT) titre
Day 21 and 42
Seroprotection rate
Day 21 and 42
Adverse events (30 minutes post vaccination period)
Day 21 and 42
15 mcg H1N1 vaccine delivered via intramuscular injection (control)
Intradermal: H1N1 vaccine delivered via intradermal injection: Experimental
Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Guangdong, China
Ivan FN Hung, MD MRCP
The University of Hong Kong
262 participants (actual enrollment reported by the registry).
First Submitted
January 12, 2010
First Posted
January 14, 2010
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers
Contact the study team to confirm eligibility.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
December 16, 2013
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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