Trial Outcomes & Findings for Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally (NCT NCT00914732)

Last Updated: 2021-02-03

Results Overview

Blood was collected from participants for testing in the PRNT assay with vaccinia-Western Reserve (replicating vaccinia) as the assay antigen. The geometric mean titers were calculated for each participant's individual peak titer after second vaccination. Titer values below limit of detection were replaced by 7.5 (half the lower limit of detection) for analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

523 participants

Primary outcome timeframe

Days 14, 28 and 180 after 2nd vaccination

Results posted on

2021-02-03

Participant Flow

Participants were healthy adults age 18 and older (born after 1971) recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09FEB2010 and 02SEP2010.

Participant milestones

Participant milestones
Measure	Lyophilized, Subcutaneous Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
Overall Study STARTED	165	167	191
Overall Study Received Second Vaccination	150	157	153
Overall Study COMPLETED	155	160	180
Overall Study NOT COMPLETED	10	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Lyophilized, Subcutaneous Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
Overall Study Lost to Follow-up	6	7	9
Overall Study Withdrawal by Subject	3	0	2
Overall Study Adverse Event	1	0	0

Baseline Characteristics

Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lyophilized, Subcutaneous n=165 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=167 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal n=191 Participants Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.	Total n=523 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
Age, Categorical Between 18 and 65 years	165 Participants n=5 Participants	167 Participants n=7 Participants	191 Participants n=5 Participants	523 Participants n=4 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
Age, Continuous	27.0 years STANDARD_DEVIATION 4.4 • n=5 Participants	26.8 years STANDARD_DEVIATION 4.5 • n=7 Participants	27.7 years STANDARD_DEVIATION 4.9 • n=5 Participants	27.2 years STANDARD_DEVIATION 4.6 • n=4 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	80 Participants n=7 Participants	102 Participants n=5 Participants	263 Participants n=4 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	87 Participants n=7 Participants	89 Participants n=5 Participants	260 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	17 Participants n=7 Participants	12 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	159 Participants n=5 Participants	150 Participants n=7 Participants	179 Participants n=5 Participants	488 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Asian	10 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	21 Participants n=4 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	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	50 Participants n=4 Participants
Race (NIH/OMB) White	129 Participants n=5 Participants	144 Participants n=7 Participants	156 Participants n=5 Participants	429 Participants n=4 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	165 participants n=5 Participants	167 participants n=7 Participants	191 participants n=5 Participants	523 participants n=4 Participants

PRIMARY outcome

Timeframe: Days 14, 28 and 180 after 2nd vaccination

Population: The ITT analysis population for the immunogenicity summaries include all participants with results for the visit. Participants were analyzed as randomized. Not receiving the second vaccination or second vaccination being out of window was not considered.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=161 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=164 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
Geometric Mean Titer (GMT) Based on Vaccinia-specific Individual Peak Plaque Reduction Neutralization Titers (PRNT) Following 2 Doses of IMVAMUNE® Lyophilized Versus Following 2 Doses of IMVAMUNE® Liquid Administered Subcutaneously, ITT Population	77.9 titer Interval 62.9 to 96.5	46.7 titer Interval 37.9 to 57.4	—

PRIMARY outcome

Timeframe: Days 14, 28 and 180 after 2nd vaccination

Population: The per protocol (PP) analysis population includes subjects who received two doses of vaccine in window and contributed both pre- and post-vaccination blood samples and had no major protocol deviations.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=145 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=149 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
GMT Based on Vaccinia-specific Individual Peak PRNT Following 2 Doses of IMVAMUNE® Lyophilized Versus Following 2 Doses of IMVAMUNE® Liquid Administered Subcutaneously, Per Protocol Population	87.8 titer Interval 71.2 to 108.3	49.5 titer Interval 40.0 to 61.3	—

PRIMARY outcome

Timeframe: Days 14, 28 and 180 after 2nd vaccination

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=187 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=164 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
GMT Based on Vaccinia-specific Individual Peak PRNT, Following 2 (Lower) Doses Liquid IMVAMUNE® Administered Intradermally Versus 2 (Higher) Doses of Liquid IMVAMUNE® Administered Subcutaneously, ITT Population	45.2 titer Interval 37.0 to 55.4	46.7 titer Interval 37.9 to 57.4	—

PRIMARY outcome

Timeframe: Days 14, 28 and 180 after 2nd vaccination

Blood was collected from participants for testing in the PRNT assay with vaccinia-Western Reserve (replicating vaccinia) as the assay antigen. The geometric mean titers were calculated for each timepoint as well as for the peak titer after second vaccination. Titer values below limit of detection were replaced by 7.5 (half the lower limit of detection) for analysis.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=146 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=149 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
GMT Based on Vaccinia-specific Individual Peak PRNT, Following 2 (Lower) Doses Liquid IMVAMUNE® Administered Intradermally Versus 2 (Higher) Doses of Liquid IMVAMUNE® Administered Subcutaneously, Per Protocol Population	59.6 titer Interval 48.1 to 74.0	49.5 titer Interval 40.0 to 61.3	—

PRIMARY outcome

Timeframe: Day 0 through 180 days after second vaccination

Population: The safety population includes all participants receiving at least one vaccination.

An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Those SAEs considered associated are those with a known temporal relationship, or the event is known to occur in association with study product or with a product in a similar class of study products AND no alternate etiology is identified.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=165 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=167 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal n=191 Participants Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
Number of Participants Reporting Serious Adverse Events Associated With IMVAMUNE® Vaccination	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Days 0, 14 and 42

Population: The safety population includes all participants receiving at least one vaccination.

Safety laboratory parameters included hemoglobin, white blood cells (WBC), platelets, ALT, and serum creatinine. These parameters were evaluated at Day 0 and 14 days after vaccination. Thresholds for Grade 3 or 4 were hemoglobin less than 8.0 g/dL, WBC less than 2000 cells/mm\^3, platelets less than 50,000 cells/mm\^3, ALT 5.0 times the upper limit of normal (ULN) or greater, and serum creatinine of 1.9 times ULN or greater. Associated with IMVAMUNE was defined as a known temporal relationship, or the event is known to occur in association with study product or with a product in a similar class of study products AND no alternate etiology is identified.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=165 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=167 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal n=191 Participants Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
Number of Participants Assessed With Grade 3 and 4 Laboratory Toxicities Associated With IMVAMUNE®.	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Days 14, 28 and 180 after 2nd vaccination

Blood was collected from participants for testing in the ELISA assay with IMVAMUNE (non-replicating vaccinia in humans) as the assay antigen. The geometric mean titers were calculated for each participant's individual peak titer after second vaccination. Titer values below limit of detection were replaced by 25 (half the lower limit of detection) for analysis.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=187 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=164 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
GMT Based on Vaccinia-specific Individual Peak ELISA Titers, Following 2 Doses (Lower) Liquid Formulation IMVAMUNE® Administered Intradermally Versus That Obtained Following 2 Doses IMVAMUNE® Liquid Formulation Administered Subcutaneously, ITT Population	554.0 titer Interval 474.2 to 647.1	700.5 titer Interval 595.4 to 824.1	—

SECONDARY outcome

Timeframe: Days 14, 28 and 180 after second vaccination

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=146 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=149 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
GMT Based on Vaccinia-specific Individual Peak ELISA Titers, Following 2 Doses (Lower) Liquid Formulation IMVAMUNE® Administered Intradermally Versus That Obtained Following 2 Doses IMVAMUNE® Liquid Formulation Subcutaneously, Per Protocol Population	757.9 titer Interval 664.4 to 864.6	769.3 titer Interval 661.8 to 894.2	—

SECONDARY outcome

Timeframe: Days 14, 28 and 180 after 2nd vaccination.

Blood was collected from participants for testing in the ELISA assay with IMVAMUNE (non-replicating vaccinia in humans) as the assay antigen. The geometric mean titers were calculated using the individual peak titer after second vaccination. Titer values below limit of detection were replaced by 25 (half the lower limit of detection) for analysis.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=159 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=164 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
GMT Based on Vaccinia-specific Individual Peak ELISA Titers Following 2 Doses of IMVAMUNE® Lyophilized Formulation Versus That Obtained Following 2 Doses of IMVAMUNE® Liquid Formulation Subcutaneously, ITT Population.	893.5 titer Interval 750.7 to 1063.5	700.5 titer Interval 595.4 to 824.1	—

SECONDARY outcome

Timeframe: Days 14, 28 and 180 after 2nd vaccination.

Blood was collected from participants for testing in the ELISA assay with IMVAMUNE (non-replicating vaccinia in humans) as the assay antigen. The geometric mean titers were calculated using the individual peak titer after second vaccination. Titer values below limit of detection were replaced by 25 (half the lower limit of detection) for analysis.

Outcome measures

Outcome measures
Measure	Lyophilized, Subcutaneous n=145 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=149 Participants Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
GMT Based on Vaccinia-specific Individual Peak ELISA Titers Following 2 Doses of IMVAMUNE® Lyophilized Formulation Versus That Obtained Following 2 Doses of IMVAMUNE® Liquid Formulation Subcutaneously, Per Protocol Population.	1062.4 titer Interval 920.8 to 1225.8	769.3 titer Interval 661.8 to 894.2	—

Adverse Events

Lyophilized, Subcutaneous

Serious events: 1 serious events

Other events: 164 other events

Deaths: 0 deaths

Liquid, Subcutaneous

Serious events: 2 serious events

Other events: 161 other events

Deaths: 0 deaths

Liquid, Intradermal

Serious events: 1 serious events

Other events: 191 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lyophilized, Subcutaneous n=165 participants at risk Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) lyophilized formulation by the subcutaneous route on Day 0 and 28.	Liquid, Subcutaneous n=167 participants at risk Participants receive a 2 dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) liquid formulation by the subcutaneous route on Day 0 and 28.	Liquid, Intradermal n=191 participants at risk Participants receive a 2 dose regimen of IMVAMUNE® (2x10\^7 TCID50/0.1mL per dose) liquid formulation by the intradermal route on Day 0 and 28.
Infections and infestations Appendicitis	0.00% 0/165 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.60% 1/167 • Number of events 1 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.00% 0/191 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/165 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.00% 0/167 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.52% 1/191 • Number of events 1 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period
Gastrointestinal disorders Colitis	0.00% 0/165 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.60% 1/167 • Number of events 1 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.00% 0/191 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period
Gastrointestinal disorders Colitis ischaemic	0.61% 1/165 • Number of events 1 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.00% 0/167 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period	0.00% 0/191 • Solicited reactogenicity symptoms were collected on memory aid for 15 days after each vaccination. Non-serious unsolicited adverse events were collected for 28 days after each vaccination. Serious adverse events were collected through 180 days after the second vaccination. Reactogenicity symptoms solicited on the memory aid are counted as an event if occurring at any time during the 15 day period

Other adverse events

Additional Information

Sharon E. Frey, M.D.

Saint Louis University Medical School

Phone: 314-977-5500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60