A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam
Sponsor study identifier
Secondary identifiers
OTHER · PATH
interventional
75
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2014
Actual (reported)June 24, 2014
Actual (reported)August 2014
Actual (reported)August 2014
Actual (reported)March 14, 2019
Actual (reported)Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose
Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.
60 min post injection
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group. Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice.
Within 7 days after injection
Number of Participants With at Least One Unsolicited AE
Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details.
Within 7 weeks of injection
All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose
The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Day 0 to Day 49
The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
Days 21 and 42
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Days 0, 21 and 42
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Days 0, 21, and 42
IVACFLU-A/H5N1, 7.5 mcg HA per dose
IVACFLU-A/H5N1, 15 mcg HA per dose.
Phosphate buffered saline
Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
Ben Luc Health Center
Bến Lức, Long An Province, Vietnam
Phan TL, Ho VT, Vu MH, Nguyen TN, Duong HT, Holt R, Wahid R, Donnelly J, Flores J. Clinical testing of an inactivated influenza A/H5N1 vaccine candidate in a double-blinded, placebo-controlled, randomized trial in healthy adults in Vietnam. Vaccine. 2016 Oct 26;34(45):5449-5456. doi: 10.1016/j.vaccine.2016.08.055. Epub 2016 Aug 31.
Le Hoang San, MD
Pasteur Institute, Ho Chi Minh City
75 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2014
First Posted
June 24, 2014
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.
Within 3 weeks of any injection
PBS, pH 7.2 in 0.5 mL single-dose vials.
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 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
March 14, 2019
Results First Posted
March 14, 2019
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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