A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
5,715
120 mcg, 3 doses, at month 0, 2, and 6.
HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Time frame: Vaccination 1 up to 6 months after Vaccination 3
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
A medically attended AE was defined as a non-serious AE that required medical attention.
Time frame: Within 30 days after Vaccination 1
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
A medically attended AE was defined as a non-serious AE that required medical attention.
Time frame: Within 30 days after Vaccination 2
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
A medically attended AE was defined as a non-serious AE that required medical attention.
Time frame: Within 30 days after Vaccination 3
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
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Accelovance,Inc.
Huntsville, Alabama, United States
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
Chandler, Arizona, United States
Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC
Chandler, Arizona, United States
Cassidy Medical Group/Clinical Research Advantage
Tempe, Arizona, United States
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
Tempe, Arizona, United States
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address
Tempe, Arizona, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Accelovance. Inc
San Diego, California, United States
Benchmark Research
San Francisco, California, United States
Cassidy Medical Group/Clinical Research Advantage
Vista, California, United States
...and 76 more locations
Time frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
A medically attended AE was defined as a non-serious AE that required medical attention.
Time frame: Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Time frame: Within 30 minutes after Vaccination 1, 2, 3
Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
Time frame: Vaccination 1 up to 1 month after Vaccination 3