Trial Outcomes & Findings for A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study (NCT NCT03089879)

Last Updated: 2019-06-28

Results Overview

IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

At Day 8 (7 days after vaccination)

Results posted on

2019-06-28

Participant Flow

A total of 35 subjects were enrolled into the study. Of these, 7 and 2 eligible subjects from the H03\_01TP parent study were enrolled into the Shigella Group and Placebo Group, respectively. 26 subjects were enrolled into the Naïve Group. All 35 subjects were vaccinated and analyzed for immunogenicity and safety.

The subjects in Naive Group, who were not part of the H03\_01TP study, were added in order to have a more balanced number of previously unvaccinated and vaccinated subjects in the extension trial.

Participant milestones

Participant milestones
Measure	Shigella Group Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Overall Study STARTED	7	2	26
Overall Study COMPLETED	7	2	26
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=2 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group n=26 Participants Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Total n=35 Participants Total of all reporting groups
Age, Continuous	37.7 Years STANDARD_DEVIATION 7.89 • n=5 Participants	40.5 Years STANDARD_DEVIATION 10.61 • n=7 Participants	33.8 Years STANDARD_DEVIATION 8.41 • n=5 Participants	34.9 Years STANDARD_DEVIATION 8.41 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	17 Participants n=5 Participants	20 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	2 Participants n=7 Participants	24 Participants n=5 Participants	32 Participants n=4 Participants
Race/Ethnicity, Customized Unspecified	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 8 (7 days after vaccination)

Population: The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=2 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group n=23 Participants Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen	168 EU/mL Interval 32.0 to 889.0	5.17 EU/mL Interval 0.033 to 810.0	38 EU/mL Interval 20.0 to 72.0

SECONDARY outcome

Timeframe: At Day 8 (7 days after vaccination) and Day 85 (84 days after vaccination)

Population: The analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo + Naïve Group).

Assessed haematological parameters are: basophils (BAS), eosinophils (EOS), erythrocytes (ERCS), hematocrit (HCT), hemoglobin (HGB), leukocytes (LKCS), lymphocytes (LYM), monocytes (MONO), neutrophils (NEU) and platelet (PLT).

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=28 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Number of Subjects With Abnormal Haematological Test Values BAS, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Within (baseline) - Below (Day 8)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Above (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Within (baseline) - Below (Day 8)	1 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Above (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Within (baseline) - Within (Day 85)	5 Participants	27 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Below (baseline) - Below (Day 85)	2 Participants	2 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Within (baseline) - Below (Day 85)	1 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Below (baseline) - Within (Day 8)	0 Participants	3 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Within (baseline) - Within (Day 8)	5 Participants	21 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Below (baseline) - Below (Day 85)	1 Participants	2 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Within (baseline) - Below (Day 85)	0 Participants	2 Participants	—
Number of Subjects With Abnormal Haematological Test Values MONO, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values BAS, Below (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values BAS, Within (baseline) - Within (Day 8)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values BAS, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values BAS, Within (baseline) - Within (Day 85)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values BAS, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Below (baseline) - Below (Day 8)	1 Participants	2 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Below (baseline) - Within (Day 8)	1 Participants	3 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Within (baseline) - Within (Day 8)	5 Participants	21 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Above (baseline) - Within (Day 8)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Below (baseline) - Below (Day 85)	1 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Within (baseline) - Below (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Above (baseline) - Below (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Below (baseline) - Within (Day 85)	1 Participants	4 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Within (baseline) - Within (Day 85)	4 Participants	22 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Below (baseline) - Above (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Within (baseline) - Above (Day 85)	1 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values EOS, Above (baseline) - Above (Day 85)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Below (baseline) - Below (Day 8)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Below (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Within (baseline) - Within (Day 8)	6 Participants	26 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Below (baseline) - Below (Day 85)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Within (baseline) - Below (Day 85)	2 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Above (baseline) - Below (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values ERCS, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Below (baseline) - Below (Day 8)	2 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Within (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Above (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Below (baseline) - Within (Day 8)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Within (baseline) - Within (Day 8)	5 Participants	26 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Above (baseline) - Below (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Within (baseline) - Within (Day 85)	4 Participants	26 Participants	—
Number of Subjects With Abnormal Haematological Test Values HCT, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Below (baseline) - Below (Day 8)	2 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Within (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Above (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Below (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Within (baseline) - Within (Day 8)	5 Participants	27 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Below (baseline) - Below (Day 85)	2 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Within (baseline) - Below (Day 85)	1 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Above (baseline) - Below (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Within (baseline) - Within (Day 85)	4 Participants	26 Participants	—
Number of Subjects With Abnormal Haematological Test Values HGB, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Below (baseline) - Below (Day 8)	1 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Within (baseline) - Below (Day 8)	0 Participants	2 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Above (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Below (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Within (baseline) - Within (Day 8)	6 Participants	25 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Below (baseline) - Above (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Within (baseline) - Above (Day 8)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Above (baseline) - Above (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Below (baseline) - Below (Day 85)	1 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Within (baseline) - Below (Day 85)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Above (baseline) - Below (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Within (baseline) - Within (Day 85)	6 Participants	26 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Below (baseline) - Above (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Within (baseline) - Above (Day 85)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values LKCS, Above (baseline) - Above (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Below (baseline) - Below (Day 8)	2 Participants	3 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Within (baseline) - Below (Day 8)	0 Participants	1 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Above (baseline) - Below (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Above (baseline) - Below (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Below (baseline) - Within (Day 85)	1 Participants	4 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Within (baseline) - Within (Day 85)	5 Participants	20 Participants	—
Number of Subjects With Abnormal Haematological Test Values LYM, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values MONO, Below (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values MONO, Within (baseline) - Within (Day 8)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values MONO, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values MONO, Within (baseline) - Within (Day 85)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values MONO, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values NEU, Below (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values NEU, Within (baseline) - Within (Day 8)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values NEU, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values NEU, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values NEU, Within (baseline) - Within (Day 85)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values NEU, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values PLT, Below (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values PLT, Within (baseline) - Within (Day 8)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values PLT, Above (baseline) - Within (Day 8)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values PLT, Below (baseline) - Within (Day 85)	0 Participants	0 Participants	—
Number of Subjects With Abnormal Haematological Test Values PLT, Within (baseline) - Within (Day 85)	7 Participants	28 Participants	—
Number of Subjects With Abnormal Haematological Test Values PLT, Above (baseline) - Within (Day 85)	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From 30 minutes through Day 7 post-vaccination

Population: The analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group).

Assessed solicited local adverse events include injection site erythema, injection site induration and injection site pain. Any symptom = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=28 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Number of Subjects With Solicited Local Adverse Events Any Erythema	1 Participants	0 Participants	—
Number of Subjects With Solicited Local Adverse Events Any Induration	0 Participants	1 Participants	—
Number of Subjects With Solicited Local Adverse Events Any Pain	6 Participants	24 Participants	—

SECONDARY outcome

Timeframe: From 30 minutes through Day 7 post-vaccination

Assessed solicited systemic adverse events include arthralgia, chills, fatigue, headache, malaise, myalgia and oral fever. Other indicators of solicited adverse events include prevention of pain and/or fever and treatment of pain and/or fever. Any symptom = occurrence of the symptom regardless of intensity grade. Fever = body temperature (measured orally) equal to or above (≥) 38.0 °C.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=28 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Number of Subjects With Solicited Systemic Adverse Events Any Arthralgia	1 Participants	3 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Any Chills	1 Participants	1 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Any Fatigue	3 Participants	11 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Any Headache	1 Participants	5 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Any Malaise	1 Participants	2 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Any Myalgia	2 Participants	8 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Fever	0 Participants	0 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Prevention of Pain and/or Fever	0 Participants	0 Participants	—
Number of Subjects With Solicited Systemic Adverse Events Treatment of Pain and/or Fever	3 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Throughout the study period (From Day 1 up to Day 85)

Population: The analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group).

An unsolicited adverse event (AE) is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Any = occurrence of the symptom regardless of intensity grade. Grade 3 AE = AE that prevented daily activity. Possibly/probably related AE = AE determined by the investigator as possibly related (the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes) or probably related (exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified) to the study vaccination.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=28 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Number of Subjects With Unsolicited Adverse Events Possibly/probably related AE(s)	0 Participants	1 Participants	—
Number of Subjects With Unsolicited Adverse Events Any AE(s)	4 Participants	7 Participants	—
Number of Subjects With Unsolicited Adverse Events Grade 3 AE(s)	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Throughout the study period (from Day 1 up to Day 85)

A serious adverse event is defined as an untoward medical occurrence that at any dose resulted in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or in a congenital anomaly/birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=28 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: At Days 15, 29 and 85 (14, 28 and 84 days after vaccination)

Population: The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and who provided immunogenicity data at relevant time points.

Concentrations of IgG against S.sonnei O-antigen are presented as GMCs, expressed in ELISA units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=2 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group n=25 Participants Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Concentrations of IgG Against LPS S. Sonnei O-antigen Day 15	883 EU/mL Interval 249.0 to 3126.0	36 EU/mL Interval 0.89 to 1474.0	106 EU/mL Interval 53.0 to 211.0
Concentrations of IgG Against LPS S. Sonnei O-antigen Day 29	623 EU/mL Interval 159.0 to 2446.0	35 EU/mL Interval 2.36 to 531.0	110 EU/mL Interval 56.0 to 213.0
Concentrations of IgG Against LPS S. Sonnei O-antigen Day 85	451 EU/mL Interval 113.0 to 1797.0	47 EU/mL Interval 0.51 to 4250.0	94 EU/mL Interval 48.0 to 184.0

SECONDARY outcome

Timeframe: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)

Population: The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and who provided immunogenicity data at relevant time points.

Within-subject Geometric mean ratios (GMRs) were computed for GMCs at 7, 14, 28 and 84 days after vaccination versus baseline (Day 1). The GMRs and 95% confidence intervals (CIs) were constructed by exponentiating the mean within-subject differences in log-transformed concentrations and the corresponding 95% CIs.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=2 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group n=25 Participants Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Anti-LPS S. Sonnei IgG Geometric Mean Ratios Day 29/Day 1	26 Ratio Interval 8.88 to 73.0	10 Ratio Interval 0.68 to 153.0	7.21 Ratio Interval 4.03 to 13.0
Anti-LPS S. Sonnei IgG Geometric Mean Ratios Day 8/Day 1	6.87 Ratio Interval 2.69 to 18.0	1.49 Ratio Interval 0.0095 to 233.0	2.32 Ratio Interval 1.42 to 3.82
Anti-LPS S. Sonnei IgG Geometric Mean Ratios Day 15/Day 1	36 Ratio Interval 14.0 to 93.0	10 Ratio Interval 0.26 to 424.0	6.88 Ratio Interval 3.77 to 13.0
Anti-LPS S. Sonnei IgG Geometric Mean Ratios Day 85/Day 1	18 Ratio Interval 5.37 to 64.0	13 Ratio Interval 0.15 to 1223.0	6.11 Ratio Interval 3.43 to 11.0

SECONDARY outcome

Timeframe: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)

Population: The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points.

Seroresponse is aimed to define a significant increase in post-vaccination samples based on the biological performance of this specific serology assay and it is defined as follows: - If the baseline value is greater than 50 ELISA Units (EU) then an increase of at least 50% in the post-vaccination sample as compared to baseline \[i.e. ((Post-vac minus baseline)/baseline)100% ≥ 50%\]. - If the baseline value is less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline \[i.e. (Postvac minus baseline) ≥ 25 EU.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=2 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group n=25 Participants Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei Day 8	86 Percentage of subjects Interval 42.1 to 99.64	0 Percentage of subjects Interval 0.0 to 84.2	26 Percentage of subjects Interval 10.2 to 48.4
Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei Day 15	100 Percentage of subjects Interval 59.0 to 100.0	50 Percentage of subjects Interval 1.3 to 98.7	72 Percentage of subjects Interval 50.6 to 87.9
Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei Day 85	100 Percentage of subjects Interval 59.0 to 100.0	100 Percentage of subjects Interval 15.8 to 100.0	64 Percentage of subjects Interval 42.5 to 82.0
Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei Day 29	100 Percentage of subjects Interval 59.0 to 100.0	100 Percentage of subjects Interval 15.8 to 100.0	67 Percentage of subjects Interval 44.7 to 84.4

SECONDARY outcome

Timeframe: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)

Population: The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points.

Anti-LPS S.sonnei antibody concentrations were assessed by ELISA. The assay cut-off value was 121 EU/mL.

Outcome measures

Outcome measures
Measure	Shigella Group n=7 Participants Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo Group n=2 Participants Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.	Naïve Group n=25 Participants Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL Day 8	71 Percentage of subjects Interval 29.0 to 96.3	0 Percentage of subjects Interval 0.0 to 84.2	30 Percentage of subjects Interval 13.2 to 52.9
Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL Day 29	86 Percentage of subjects Interval 42.1 to 99.64	0 Percentage of subjects Interval 0.0 to 84.2	42 Percentage of subjects Interval 22.1 to 63.4
Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL Day 15	86 Percentage of subjects Interval 42.1 to 99.64	0 Percentage of subjects Interval 0.0 to 84.2	40 Percentage of subjects Interval 21.1 to 61.3
Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL Day 85	86 Percentage of subjects Interval 42.1 to 99.64	0 Percentage of subjects Interval 0.0 to 84.2	40 Percentage of subjects Interval 21.1 to 61.3

Adverse Events

Shigella Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo + Naïve Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Shigella Group n=7 participants at risk Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.	Placebo + Naïve Group n=28 participants at risk Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline (Placebo Group), or subjects who were not part of H03\_01TP parent study (Naïve Group) were pooled into the Placebo + Naïve Group. All subjects received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
General disorders Chills	14.3% 1/7 • Number of events 1 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	3.6% 1/28 • Number of events 1 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
General disorders Fatigue	42.9% 3/7 • Number of events 3 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	39.3% 11/28 • Number of events 12 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
General disorders Injection site erythema	28.6% 2/7 • Number of events 2 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	28.6% 8/28 • Number of events 8 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
General disorders Injection site induration	28.6% 2/7 • Number of events 2 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	35.7% 10/28 • Number of events 10 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
General disorders Injection site pain	85.7% 6/7 • Number of events 6 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	85.7% 24/28 • Number of events 24 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
General disorders Malaise	14.3% 1/7 • Number of events 1 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	7.1% 2/28 • Number of events 2 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
Infections and infestations Nasopharyngitis	14.3% 1/7 • Number of events 1 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	0.00% 0/28 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Number of events 2 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	10.7% 3/28 • Number of events 3 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.3% 1/7 • Number of events 1 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	0.00% 0/28 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
Musculoskeletal and connective tissue disorders Myalgia	28.6% 2/7 • Number of events 2 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	28.6% 8/28 • Number of events 8 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
Nervous system disorders Headache	28.6% 2/7 • Number of events 3 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	21.4% 6/28 • Number of events 9 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.
Reproductive system and breast disorders Dysmenorrhoea	14.3% 1/7 • Number of events 1 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.	3.6% 1/28 • Number of events 1 • Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85). For the purpose of the safety analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group). Both groups include vaccine naïve subjects since the placebo recipients in the parent trial did not receive a Shigella vaccine, nor did the naïve subjects who were not part of the parent trial.

Additional Information

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