PSC25
Phase 2 Observer-Blind, Randomized Trial to Evaluate the Immunogenicity and Safety of PanBlok at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With PanBlok Without Adjuvant in Healthy Adults Aged 18 to 49 Years
Sponsor study identifier
interventional
341
1 country
5
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
December 2013
Actual (reported)The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
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.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 7, 2012
Actual (reported)June 5, 2012
Actual (reported)August 2013
Actual (reported)December 2013
Actual (reported)November 25, 2015
Actual (reported)The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
42 Days
The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
42 Days
Reactogenicity Immediately After Each Injection, Extending to Day 7.
7 Days
Long-term Safety
13 Months
15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Intramuscular injection
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
University of Rochester Center for Vaccine Studies
Rochester, New York, 14627, United States
Benchmark Reseach
Austin, Texas, 78705, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Treanor JJ, Chu L, Essink B, Muse D, El Sahly HM, Izikson R, Goldenthal KL, Patriarca P, Dunkle LM. Stable emulsion (SE) alone is an effective adjuvant for a recombinant, baculovirus-expressed H5 influenza vaccine in healthy adults: A Phase 2 trial. Vaccine. 2017 Feb 7;35(6):923-928. doi: 10.1016/j.vaccine.2016.12.053. Epub 2017 Jan 11.
John J Treanor, MD
University of Rochester
341 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2012
First Posted
June 5, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza
7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Intramuscular injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
November 25, 2015
Results First Posted
November 25, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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