Trial Outcomes & Findings for V710 First-In-Man (FIM) Study (V710-001) (NCT NCT00303069)

Last Updated: 2015-07-22

Results Overview

Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

124 participants

Primary outcome timeframe

Through Day 84 postvaccination

Results posted on

2015-07-22

Participant Flow

Phase I; First Subject In: 06-Dec-2005; Last Subject Out: 31-Jul-2006. Enrollment occurred at 6 investigative sites in the United States.

Subject was 18 to 55 years old; in good physical health based upon medical history, physical exam, and screening tests; able to understand study procedures and provided written consent; willing and able to complete entire study; and (if female) provided negative urine pregnancy test before vaccination and using an accepted method of birth control.

Participant milestones

Participant milestones
Measure	V710 5 μg Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3). Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.	V710 30 μg Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3). Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.	V710 90 μg Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3). Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.	Placebo Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3). Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.
Overall Study STARTED	31	28	34	31
Overall Study COMPLETED	29	28	33	29
Overall Study NOT COMPLETED	2	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	V710 5 μg Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3). Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.	V710 90 μg Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3). Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.	Placebo Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3). Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age.
Overall Study Lost to Follow-up	1	0	2
Overall Study subject moved	1	0	0
Overall Study Recruitment into Army Reserves	0	1	0

Baseline Characteristics

V710 First-In-Man (FIM) Study (V710-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V710 5 μg n=31 Participants V710 5 μg single dose at baseline.	V710 30 μg n=28 Participants V710 30 μg single dose at baseline.	V710 90 μg n=34 Participants V710 90 μg single dose at baseline.	Placebo n=31 Participants Saline placebo single dose at baseline.	Total n=124 Participants Total of all reporting groups
Age, Customized 17 years of age and under	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, Customized 18 to 29 years of age	10 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	10 participants n=4 Participants	33 participants n=21 Participants
Age, Customized 30 to 39 years of age	7 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants	5 participants n=4 Participants	32 participants n=21 Participants
Age, Customized 40 to 49 years of age	11 participants n=5 Participants	8 participants n=7 Participants	11 participants n=5 Participants	11 participants n=4 Participants	41 participants n=21 Participants
Age, Customized 50 to 55 years of age	3 participants n=5 Participants	7 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants	18 participants n=21 Participants
Age, Customized Over 55 years of age	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
Sex: Female, Male Female	13 Participants n=5 Participants	21 Participants n=7 Participants	16 Participants n=5 Participants	18 Participants n=4 Participants	68 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants	13 Participants n=4 Participants	56 Participants n=21 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	7 participants n=21 Participants
Race/Ethnicity, Customized Black	9 participants n=5 Participants	8 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	25 participants n=21 Participants
Race/Ethnicity, Customized Hispanic-American	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized Multiracial	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized Native American	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized White	18 participants n=5 Participants	19 participants n=7 Participants	26 participants n=5 Participants	21 participants n=4 Participants	84 participants n=21 Participants

PRIMARY outcome

Timeframe: Through Day 84 postvaccination

Population: The population analyzed included all subjects who were randomized, vaccinated, and had safety follow-up.

Outcome measures

Outcome measures
Measure	V710 5 μg n=31 Participants V710 5 μg single dose at baseline.	V710 30 μg n=28 Participants V710 30 μg single dose at baseline.	V710 90 μg n=34 Participants V710 90 μg single dose at baseline.	Placebo n=31 Participants Saline placebo single dose at baseline.
Number of Vaccine-related Serious Adverse Experiences Following Vaccination Experienced a vaccine-related SAE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Vaccine-related Serious Adverse Experiences Following Vaccination Did not experience a vaccine-related SAE	31 Participants	28 Participants	34 Participants	31 Participants

PRIMARY outcome

Timeframe: Baseline and Day 14 postvaccination

Population: The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.

Outcome measures

Outcome measures
Measure	V710 5 μg n=31 Participants V710 5 μg single dose at baseline.	V710 30 μg n=28 Participants V710 30 μg single dose at baseline.	V710 90 μg n=31 Participants V710 90 μg single dose at baseline.	Placebo n=28 Participants Saline placebo single dose at baseline.
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination Fold-rise in antibody titer ≥2	9 Participants	24 Participants	27 Participants	1 Participants
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination Fold-rise in antibody titer <2	22 Participants	4 Participants	4 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline and Day 7 postvaccination

Outcome measures

Outcome measures
Measure	V710 5 μg n=31 Participants V710 5 μg single dose at baseline.	V710 30 μg n=28 Participants V710 30 μg single dose at baseline.	V710 90 μg n=33 Participants V710 90 μg single dose at baseline.	Placebo n=30 Participants Saline placebo single dose at baseline.
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination Fold-rise in antibody titer ≥2	1 Participants	4 Participants	10 Participants	0 Participants
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination Fold-rise in antibody titer <2	30 Participants	24 Participants	23 Participants	30 Participants

Adverse Events

V710 5 μg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

V710 30 μg

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

V710 90 μg

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	V710 5 μg n=31 participants at risk V710 5 μg single dose at baseline.	V710 30 μg n=28 participants at risk V710 30 μg single dose at baseline.	V710 90 μg n=34 participants at risk V710 90 μg single dose at baseline.	Placebo n=31 participants at risk Saline placebo single dose at baseline.
Gastrointestinal disorders Diarrhoea	0.00% 0/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	7.1% 2/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Gastrointestinal disorders Dyspepsia	0.00% 0/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	2.9% 1/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	6.5% 2/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Gastrointestinal disorders Nausea	6.5% 2/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	10.7% 3/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	8.8% 3/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	9.7% 3/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
General disorders Fatigue	16.1% 5/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	10.7% 3/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	8.8% 3/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	12.9% 4/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Infections and infestations Nasopharyngitis	0.00% 0/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	7.1% 2/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Skin and subcutaneous tissue disorders Injection-site erythema	9.7% 3/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	9.7% 3/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Skin and subcutaneous tissue disorders Injection-site pain	45.2% 14/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	60.7% 17/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	58.8% 20/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	22.6% 7/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Skin and subcutaneous tissue disorders Injection-site swelling	6.5% 2/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	10.7% 3/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	2.9% 1/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	9.7% 3/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Investigations Blood alkaline phosphatase increased	0.00% 0/11 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	22.2% 2/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/7 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Investigations Blood bilirubin increased	0.00% 0/11 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	11.1% 1/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/7 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Investigations Hemoglobin decreased	9.1% 1/11 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	11.1% 1/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/7 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Investigations Protein urine present	9.1% 1/11 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	14.3% 1/7 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Investigations White blood cell count decreased	0.00% 0/11 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	11.1% 1/9 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/7 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	6.5% 2/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Musculoskeletal and connective tissue disorders Myalgia	9.7% 3/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	7.1% 2/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	8.8% 3/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	22.6% 7/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Nervous system disorders Headache	19.4% 6/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	25.0% 7/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	17.6% 6/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	12.9% 4/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Psychiatric disorders Insomnia	0.00% 0/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	7.1% 2/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	3.2% 1/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.2% 1/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	7.1% 2/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	3.2% 1/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	6.5% 2/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	7.1% 2/28 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	0.00% 0/34 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.	3.2% 1/31 • Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study). Specific systemic AEs: fatigue, headache, myalgia, and nausea for 14 days (D) postvaccination (PV). Injection-site AEs including maximum intensity/size for 5D PV. Elevated body temperatures for 5D PV. Subjects in Panel A (N=36) were actively followed for laboratory (lab) AEs for 7D PV. Any lab abnormalities at D7 PV were followed until resolution.