Trial Outcomes & Findings for High Dose IMVAMUNE® in Vaccinia-Naive Individuals (NCT NCT00879762)

Last Updated: 2025-06-13

Results Overview

Seroconversion is defined as a titer \>= 50 or as a 2-fold or greater increase in titer from baseline if pre-vaccination titer was \>= 50. Participants who did not seroconvert during the study were analyzed as right censored at the last sample collection date. Samples collected after the second vaccination were also analyzed as right censored.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

91 participants

Primary outcome timeframe

Days 0, 4, 8, 14, 21, and 28 after first vaccination

Results posted on

2025-06-13

Participant Flow

The study population included vaccinia-naïve adults aged greater than 18 years (and born after 1971). Participants were recruited from two sites within the United States. The first participant was enrolled on May 29, 2009, and the last participant was enrolled on August 16, 2010.

Participant milestones

Participant milestones
Measure	Group A: High Dose Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B. IMVAMUNE® High Dose: IMVAMUNE® Vaccinia Vaccine, undiluted, delivered by subcutaneous route on Day 0 at high dose 5×10\^8 TCID50 (5×10\^8 TCID50 per 1.0 mL dose - administered as 2 x 0.5 mL. Placebo: 0.5 mL injection of saline placebo administered with vaccine on Day 0 (Group B) or single saline placebo dose (single 0.5 mL injection) on Day 28 (Group A).	Group B: Standard Dose Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine). Placebo: 0.5 mL injection of saline placebo administered with vaccine on Day 0 (Group B) or single saline placebo dose (single 0.5 mL injection) on Day 28 (Group A). IMVAMUNE® Standard Dose: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route on Day 0 and 28 at standard dose (diluted with saline by study pharmacist to (1×10\^8 tissue culture infectious dose 50 \[TCID50\] per 0.5 mL dose)
Overall Study STARTED	46	45
Overall Study COMPLETED	43	44
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: High Dose Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B. IMVAMUNE® High Dose: IMVAMUNE® Vaccinia Vaccine, undiluted, delivered by subcutaneous route on Day 0 at high dose 5×10\^8 TCID50 (5×10\^8 TCID50 per 1.0 mL dose - administered as 2 x 0.5 mL. Placebo: 0.5 mL injection of saline placebo administered with vaccine on Day 0 (Group B) or single saline placebo dose (single 0.5 mL injection) on Day 28 (Group A).	Group B: Standard Dose Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine). Placebo: 0.5 mL injection of saline placebo administered with vaccine on Day 0 (Group B) or single saline placebo dose (single 0.5 mL injection) on Day 28 (Group A). IMVAMUNE® Standard Dose: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route on Day 0 and 28 at standard dose (diluted with saline by study pharmacist to (1×10\^8 tissue culture infectious dose 50 \[TCID50\] per 0.5 mL dose)
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

High Dose IMVAMUNE® in Vaccinia-Naive Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).	Total n=90 Participants Total of all reporting groups
Age, Continuous	26.9 years STANDARD_DEVIATION 4.6 • n=93 Participants	26.8 years STANDARD_DEVIATION 4.8 • n=4 Participants	26.8 years STANDARD_DEVIATION 4.7 • n=27 Participants
Sex: Female, Male Female	24 Participants n=93 Participants	24 Participants n=4 Participants	48 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=93 Participants	42 Participants n=4 Participants	84 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants	39 Participants n=4 Participants	80 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Days 0, 4, 8, 14, 21, and 28 after first vaccination

Population: The ITT population includes all participants enrolled and randomized. Participants in this population are analyzed according to the group they were randomized to.

Outcome measures

Outcome measures
Measure	Group A: High Dose n=46 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Time to Seroconversion After One Vaccination Using Bavarian Nordic's (BN) Enzyme Linked Immunosorbent Assay (ELISA) in the Intent-to-Treat (ITT) Population	14 days Interval 13.0 to 14.0	14 days Interval 13.0 to 14.0

PRIMARY outcome

Timeframe: Days 0, 4, 8, 14, 21, and 28 after first vaccination

Population: The per protocol population includes all participants who received one dose of vaccine and contributed both pre- and post-vaccination blood samples for testing for which valid results were reported. One participant in Group A was additionally excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.

Outcome measures

Outcome measures
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Time to Seroconversion After One Vaccination Using BN ELISA in the Per Protocol Population	14 days Interval 13.0 to 14.0	14 days Interval 13.0 to 14.0

PRIMARY outcome

Timeframe: Day 0 after first vaccination to study completion through Day 180 after second vaccination (Day 208 after first vaccination)

Population: The safety population includes all participants who received one dose of vaccine. One participant in Group A was additionally excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.

The number of participants who experienced at least one SAE throughout the course of the study that was deemed related to the study vaccination. A SAE is defined as an AE meeting one of the following conditions: * Death during the study period (from first vaccine until end of surveillance period) * Life-threatening (defined as a participant at immediate risk of death at the time of the event) * Requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol-defined surveillance * Results in a congenital anomaly or birth defect * Results in a persistent or significant disability/incapacity * Severe adverse event associated with study product

Outcome measures

Outcome measures
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Frequency of Serious Adverse Events (SAEs) Related to Vaccination	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 after first vaccination to Day 28 after second vaccination (Day 56 after first vaccination)

The number of participants who experienced at least one unsolicited non-serious AE of any severity from Day 0 to 28 days post second vaccination (56 days post first vaccination) that was deemed related to the study vaccination.

Outcome measures

Outcome measures
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Frequency of Non-Serious AEs Related to Vaccination	11 Participants	9 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 15 after first vaccination; Day 0 through Day 15 after second vaccination (Day 28 through Day 43 after first vaccination)

Local solicited reactogenicity AEs were collected daily for 15 days post each vaccination using a memory aid. Local subjective events included pain at injection site, itchiness at injection site, underarm pain, and underarm swelling and were graded on a scale of Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe).

Outcome measures

Outcome measures
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Frequency of Local Solicited Reactogenicity AEs for Subjective Symptoms Post Vaccination 1 (Day 0 through Day 15)	41 Participants	34 Participants
Frequency of Local Solicited Reactogenicity AEs for Subjective Symptoms Post Vaccination 2 (Day 28 through Day 43)	7 Participants	33 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 15 after first vaccination; Day 0 through Day 15 after second vaccination (Day 28 through Day 43 after first vaccination)

Local solicited reactogenicity AEs were collected daily for 15 days post each vaccination using a memory aid. Local measured events included erythema and induration at the vaccination site and were measured in millimeters.

Outcome measures

Outcome measures
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Frequency of Local Solicited Reactogenicity AEs for Measured Symptoms Post Vaccination 1 (Day 0 through Day 15)	26 Participants	22 Participants
Frequency of Local Solicited Reactogenicity AEs for Measured Symptoms Post Vaccination 2 (Day 28 to Day 43)	3 Participants	20 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 15 after first vaccination; Day 0 through Day 15 after second vaccination (Day 28 through Day 43 after first vaccination)

Systemic solicited reactogenicity AEs were collected daily for 15 days post each vaccination using a memory aid. Systemic events included muscle aches, chills, headache, nausea, feeling tired, change in appetite, joint pain, and elevated oral temperature. Events were graded on a scale of Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe).

Outcome measures

Outcome measures
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Frequency of Systemic Solicited Reactogenicity AEs Post Vaccination 1 (Day 0 through Day 15)	27 Participants	19 Participants
Frequency of Systemic Solicited Reactogenicity AEs Post Vaccination 2 (Day 28 to Day 43)	7 Participants	11 Participants

SECONDARY outcome

Timeframe: Days 4, 8, 14, 21, and 28 after first vaccination

Population: The ITT population includes all participants enrolled and randomized. Participants in this population are analyzed according to the group they were randomized to.

The peak PRNT is defined as the largest titer among all available measurements post-first vaccination but prior to the second vaccination. Means and corresponding standard errors are calculated on the log2.5 scale.

Outcome measures

Outcome measures
Measure	Group A: High Dose n=46 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Peak Titer of Saint Louis University's (SLU) Plaque Reduction Neutralizing Antibody Titer (PRNT) Assay After First Vaccination in the ITT Population	4.94 log2.5 of titer Standard Error 0.19	4.56 log2.5 of titer Standard Error 0.23

SECONDARY outcome

Timeframe: Days 4, 8, 14, 21, and 28 after first vaccination

Population: The ITT population includes all participants enrolled and randomized. Participants in this population are analyzed according to the group they were randomized to.

Outcome measures

Outcome measures
Measure	Group A: High Dose n=45 Participants Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 Participants Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Peak Titer of SLU PRNT Assay After First Vaccination in the Per Protocol Population	4.98 log2.5 of titer Standard Error 0.19	4.56 log2.5 of titer Standard Error 0.23

Adverse Events

Group A: High Dose

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Group B: Standard Dose

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Sharon E. Frey, M.D.

Saint Louis University Medical Center

Phone: 315-977-5500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Group A: High Dose n=45 participants at risk Single high dose of IMVAMUNE® (5x10\^8 TCID50, consisting of two 0.5 mL injections) vaccine on Day 0 and a single saline placebo dose (single 0.5 mL injection) on Day 28 to match the two dose regimen of Group B.	Group B: Standard Dose n=45 participants at risk Standard two dose regimen of IMVAMUNE® (1x10\^8 TCID50) vaccine on Day 0 (consisting of 0.5 mL injection of vaccine and 0.5 mL injection of saline placebo) and Day 28 (single 0.5 mL injection of vaccine).
Gastrointestinal disorders Diarrhoea	6.7% 3/45 • Number of events 3 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	0.00% 0/45 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Vaccination site discolouration	6.7% 3/45 • Number of events 3 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	11.1% 5/45 • Number of events 6 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Vaccination site haematoma	2.2% 1/45 • Number of events 1 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	8.9% 4/45 • Number of events 4 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
Infections and infestations Upper respiratory tract infection	2.2% 1/45 • Number of events 1 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	8.9% 4/45 • Number of events 4 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
Gastrointestinal disorders Nausea	8.9% 4/45 • Number of events 5 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	11.1% 5/45 • Number of events 5 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Axillary pain	11.1% 5/45 • Number of events 5 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	20.0% 9/45 • Number of events 11 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Chills	11.1% 5/45 • Number of events 5 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	4.4% 2/45 • Number of events 2 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Fatigue	33.3% 15/45 • Number of events 20 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	24.4% 11/45 • Number of events 13 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Underarm swelling	6.7% 3/45 • Number of events 3 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	8.9% 4/45 • Number of events 5 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Vaccination site erythema	51.1% 23/45 • Number of events 25 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	66.7% 30/45 • Number of events 43 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Vaccination site pain	88.9% 40/45 • Number of events 45 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	86.7% 39/45 • Number of events 68 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Vaccination site pruritus	22.2% 10/45 • Number of events 10 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	22.2% 10/45 • Number of events 14 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
General disorders Vaccination site swelling	48.9% 22/45 • Number of events 22 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	60.0% 27/45 • Number of events 36 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
Metabolism and nutrition disorders Appetite disorder	13.3% 6/45 • Number of events 6 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	0.00% 0/45 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
Musculoskeletal and connective tissue disorders Arthralgia	15.6% 7/45 • Number of events 7 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	8.9% 4/45 • Number of events 4 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 15/45 • Number of events 18 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	22.2% 10/45 • Number of events 12 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.
Nervous system disorders Headache	37.8% 17/45 • Number of events 21 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.	24.4% 11/45 • Number of events 14 • Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were reported from the first vaccination through 28 days post second vaccination (56 days post first vaccination). SAEs were reported from the first vaccination to study completion (Day 208 post first vaccination). AEs are presented by actual study product received. One participant in Group A was excluded due to receiving an incorrect dose for the first vaccination that did not correspond to either study group.