Trial Outcomes & Findings for Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE® (NCT NCT01827371)

Last Updated: 2016-09-07

Results Overview

Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

435 participants

Primary outcome timeframe

Day 7 through Day 31 after 2nd vaccination

Results posted on

2016-09-07

Participant Flow

Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 17JUN2013 and 23SEP2014.

Participant milestones

Participant milestones
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
Overall Study STARTED	115	96	104	120
Overall Study COMPLETED	102	89	93	97
Overall Study NOT COMPLETED	13	7	11	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
Overall Study Adverse Event	0	0	4	2
Overall Study Lost to Follow-up	0	2	0	4
Overall Study Protocol Violation	1	0	0	0
Overall Study Withdrawal by Subject	1	2	2	3
Overall Study Physician Decision	0	1	0	1
Overall Study Temporary study halt to vaccinations	11	2	5	13

Baseline Characteristics

Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle n=115 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle n=96 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle n=104 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis n=120 Participants IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.	Total n=435 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	115 Participants n=5 Participants	96 Participants n=7 Participants	104 Participants n=5 Participants	120 Participants n=4 Participants	435 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	27.2 years STANDARD_DEVIATION 5.6 • n=5 Participants	27.1 years STANDARD_DEVIATION 5.4 • n=7 Participants	27.2 years STANDARD_DEVIATION 5.0 • n=5 Participants	27.9 years STANDARD_DEVIATION 5.2 • n=4 Participants	27.4 years STANDARD_DEVIATION 5.3 • n=21 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	49 Participants n=7 Participants	59 Participants n=5 Participants	60 Participants n=4 Participants	229 Participants n=21 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	47 Participants n=7 Participants	45 Participants n=5 Participants	60 Participants n=4 Participants	206 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	33 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=5 Participants	92 Participants n=7 Participants	92 Participants n=5 Participants	113 Participants n=4 Participants	401 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	12 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	18 Participants n=4 Participants	70 Participants n=21 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants	70 Participants n=7 Participants	74 Participants n=5 Participants	86 Participants n=4 Participants	311 Participants n=21 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	115 participants n=5 Participants	96 participants n=7 Participants	104 participants n=5 Participants	120 participants n=4 Participants	435 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 7 through Day 31 after 2nd vaccination

Population: The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.

Outcome measures

Outcome measures
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle n=84 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle n=85 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle n=84 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis n=79 Participants IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination	138.0 titers Interval 110.1 to 172.8	55.1 titers Interval 42.3 to 71.7	75.9 titers Interval 58.5 to 98.4	103.5 titers Interval 80.8 to 132.6

PRIMARY outcome

Timeframe: 15 days after each vaccination

Population: All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.

Participants maintained a memory aid to record daily the occurrence of local injection site reactions for 15 days after vaccination based on their interference with daily activities (pain and itchiness at injection site, underarm pain and swelling) or based on a quantitative measurement of the reaction (redness, swelling). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions were present but did not interfere with daily activities. For the quantitative scale, severe reactions greater than 30 millimeters (mm), moderate reactions were 15-30mm, and mild reactions were 1-15mm. Participants are counted by the maximum severity on any of the 15 days, and for this outcome measure, only those reporting moderate or severe events are counted. Formal comparisons by Fisher's Exact test were conducted for Arm D (Stratis, Day 1,29) compared to A

Outcome measures

Outcome measures
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle n=116 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle n=96 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle n=103 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis n=120 Participants IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration Pain at Injection Site	28 percentage of participants	36 percentage of participants	26 percentage of participants	33 percentage of participants
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration Itchiness at Injection Site	6 percentage of participants	10 percentage of participants	17 percentage of participants	12 percentage of participants
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration Underarm Pain	4 percentage of participants	4 percentage of participants	3 percentage of participants	5 percentage of participants
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration Underarm Swelling	2 percentage of participants	2 percentage of participants	2 percentage of participants	1 percentage of participants
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration Redness at Injection Site	54 percentage of participants	52 percentage of participants	60 percentage of participants	79 percentage of participants
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration Swelling at Injection Site	52 percentage of participants	47 percentage of participants	52 percentage of participants	70 percentage of participants
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration Any Solicited Local Symptom	73 percentage of participants	69 percentage of participants	77 percentage of participants	90 percentage of participants

SECONDARY outcome

Timeframe: Day 7 through 31 after the 2nd vaccination

Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of antibody titers by ELISA. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.

Outcome measures

Outcome measures
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle n=84 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle n=85 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle n=84 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis n=79 Participants IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
Geometric Mean Peak ELISA Titer After Second Vaccination	1259.8 titers Interval 1093.0 to 1451.9	741.4 titers Interval 625.0 to 879.6	1021.0 titers Interval 878.1 to 1187.1	1351.8 titers Interval 1130.0 to 1617.1

SECONDARY outcome

Timeframe: Day 1 after the first vaccination through 180 days after the 2nd vaccination.

Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with IMVAMUNE was determined by the investigator and defined as "Related", meaning a reasonable possibility that the study product caused the adverse event. Reasonable possibility was defined as there being evidence to suggest a causal relationship between the study product and the adverse event.

Outcome measures

Outcome measures
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle n=116 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle n=96 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle n=103 Participants IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis n=120 Participants IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE	1 participants	0 participants	1 participants	0 participants

Adverse Events

Arm A: IMVAMUNE Days 1+29, Syringe and Needle

Serious events: 2 serious events

Other events: 114 other events

Deaths: 0 deaths

Arm B: IMVAMUNE Days 1+15, Syringe and Needle

Serious events: 1 serious events

Other events: 94 other events

Deaths: 0 deaths

Arm C: IMVAMUNE Days 1+22, Syringe and Needle

Serious events: 1 serious events

Other events: 103 other events

Deaths: 0 deaths

Arm D: IMVAMUNE Days 1+29, Stratis

Serious events: 1 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: IMVAMUNE Days 1+29, Syringe and Needle n=116 participants at risk IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.	Arm B: IMVAMUNE Days 1+15, Syringe and Needle n=96 participants at risk IMVAMUNE 1x10\^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.	Arm C: IMVAMUNE Days 1+22, Syringe and Needle n=103 participants at risk IMVAMUNE 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.	Arm D: IMVAMUNE Days 1+29, Stratis n=120 participants at risk IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
Cardiac disorders Acute myocardial infarction	0.86% 1/116 • Number of events 1 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/96 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/103 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/120 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.
Injury, poisoning and procedural complications Intentional overdose	0.86% 1/116 • Number of events 1 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/96 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/103 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/120 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/116 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	1.0% 1/96 • Number of events 1 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/103 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/120 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.
Immune system disorders Type I hypersensitivity	0.00% 0/116 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/96 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.97% 1/103 • Number of events 1 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/120 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/116 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/96 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.00% 0/103 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.	0.83% 1/120 • Number of events 1 • Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination. Subjects were analyzed as treated for the safety population, so one subject randomized to Arm C but vaccinated out of window, equivalent to the schedule for Arm A, was analyzed as an Arm A subject.

Other adverse events

Additional Information

Lisa Jackson, M.D., M.P.H.

Group Health Research Institute

Phone: 206-442-5216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60