Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults (NCT NCT03527173)
NCT ID: NCT03527173
Last Updated: 2020-07-28
Results Overview
Attack rate of shigellosis expressed as percentage of subjects with at least one episode of shigellosis after challenge, and 90% confidence interval (CI) (Clopper-Pearson method). Episodes of shigellosis fulfilling primary case definition: Shedding of S. sonnei 53G accompanied by moderate or severe diarrhea OR shedding with oral temperature greater than or equal to (≥) 38.5°C. Moderate diarrhea consists of 4 to 5 loose or watery (Grade \[G\]3 to 5) stools or 400 to 800 grams of G3 to 5 stools within 24 hours. Severe diarrhea consists of 6 or more loose or watery (G3 to 5) stools or \> 800 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Results posted on
2020-07-28
Participant Flow
This study was conducted at one center in the United States of America (USA).
All 71 subjects enrolled in the study, received a study vaccination and were included in the All Exposed Set.
Participant milestones
| Measure |
S. Sonnei Group
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
S. Sonnei Group
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
ELIGIBILITY CRITERIA NOT FULFILLED
|
1
|
0
|
|
Overall Study
CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT
|
1
|
5
|
|
Overall Study
NOT WILLING TO PARTICIPATE THIS VISIT
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults
Baseline characteristics by cohort
| Measure |
S. Sonnei Group
n=36 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
35.2 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
35.7 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
OTHER - UNSPECIFIED
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent.
Attack rate of shigellosis expressed as percentage of subjects with at least one episode of shigellosis after challenge, and 90% confidence interval (CI) (Clopper-Pearson method). Episodes of shigellosis fulfilling primary case definition: Shedding of S. sonnei 53G accompanied by moderate or severe diarrhea OR shedding with oral temperature greater than or equal to (≥) 38.5°C. Moderate diarrhea consists of 4 to 5 loose or watery (Grade \[G\]3 to 5) stools or 400 to 800 grams of G3 to 5 stools within 24 hours. Severe diarrhea consists of 6 or more loose or watery (G3 to 5) stools or \> 800 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid.
Outcome measures
| Measure |
S. Sonnei Group
n=32 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=28 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Percentage of Subjects With at Least One Episode of Shigellosis According to the Protocol Primary Case Definition
|
46.9 Percentage of subjects
Interval 31.5 to 62.7
|
42.9 Percentage of subjects
Interval 26.9 to 60.0
|
SECONDARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent.
Percentage of subjects with shigellosis fulfilling the CHIM expert working group case definition for shigellosis, and 90% confidence interval (CI) (Clopper-Pearson method). According to the working group, the participant must fulfil any of the three following possible endpoints to qualify as having reached the CHIM case definition for this objective: 1. Severe diarrhea defined as \[\[≥ 6 loose stools in 24 hours\] OR \[˃800 grams loose stools in 24 hours\]; 2. Moderate diarrhea defined as \[4-5 loose stools in 24 hours OR 400-800 grams loose stools in 24 hours\] AND \[oral temperature \[≥ 38.0°C OR \[≥ 1 moderate constitutional/enteric symptom OR \[≥ 2 episodes of vomiting in 24 hours\]; 3. Dysentery defined as \[\[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours\] AND \[oral temperature \[≥ 38.0°C OR \[≥ 1 moderate constitutional/enteric symptom OR \[≥ 2 episodes of vomiting in 24 hours\].
Outcome measures
| Measure |
S. Sonnei Group
n=32 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=28 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Percentage of Subjects With at Least One Episode of Shigellosis According to Controlled Human Infection Model (CHIM) Working Group Case Definition for Shigellosis
|
46.9 Percentage of subjects
Interval 31.5 to 62.7
|
32.1 Percentage of subjects
Interval 17.9 to 49.4
|
SECONDARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent.
Percentage of subjects with shigellosis fulfilling the following definition of shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) severe diarrhea OR 2) moderate diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 moderate constitutional/enteric symptom OR 3) dysentery \[\[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours\] AND \[≥ 1 reportable constitutional/enteric symptom\]\].
Outcome measures
| Measure |
S. Sonnei Group
n=32 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=28 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Percentage of Subjects With at Least One Episode of Shigellosis
|
46.9 Percentage of subjects
Interval 31.5 to 62.7
|
35.7 Percentage of subjects
Interval 20.8 to 53.0
|
SECONDARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent.
Percentage of subjects with more severe shigellosis fulfilling the following definition of more severe shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) moderate OR severe diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 severe constitutional/enteric symptom OR 2) dysentery \[\[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours\] AND \[oral temperature ≥ 38.0°C OR ≥ 1 severe constitutional/enteric symptom\]\].
Outcome measures
| Measure |
S. Sonnei Group
n=32 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=28 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Percentage of Subjects With at Least One Episode of More Severe Shigellosis
|
15.6 Percentage of subjects
Interval 6.4 to 30.1
|
14.3 Percentage of subjects
Interval 5.0 to 29.8
|
SECONDARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent.
Percentage of subjects with 90% CI-Clopper-Pearson method was also measured for: shedding of S.sonnei strain 53G (defined as positivity of ≥1 stool sample by culture/quantitative Polymerase Chain Reaction/both); severe diarrhea; more severe diarrhea; dysentery; confirmed S.sonnei 53G shedding AND moderate or severe diarrhea OR dysentery OR presence of oral temperature ≥ 38.5°C OR presence of 1 or more severe intestinal symptoms (abdominal pain, cramping, nausea, vomiting, gas, and anorexia) abbreviated as "shedding of S.sonnei 53G and \[…"; disease not fulfilling the protocol primary case definition for shigellosis associated or not with mild to moderate symptoms including: ≥1 stool and no moderate or severe diarrhea evidence, abdominal pain, abdominal cramps, gas, anorexia, nausea, headache, myalgia, malaise, arthralgia, fever, vomiting and intravenous fluid administration. Any=any symptom regardless of intensity grade or relation to study vaccination and/or challenge administration.
Outcome measures
| Measure |
S. Sonnei Group
n=32 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=28 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Percentage of Subjects With Specific Disease Symptoms
Shedding of S. sonnei strain 53G
|
96.9 Percentage of subjects
Interval 86.0 to 99.8
|
100 Percentage of subjects
Interval 89.9 to 100.0
|
|
Percentage of Subjects With Specific Disease Symptoms
Severe diarrhea
|
40.6 Percentage of subjects
Interval 26.0 to 56.7
|
25 Percentage of subjects
Interval 12.4 to 41.9
|
|
Percentage of Subjects With Specific Disease Symptoms
More severe diarrhea
|
34.4 Percentage of subjects
Interval 20.6 to 50.4
|
17.9 Percentage of subjects
Interval 7.3 to 33.9
|
|
Percentage of Subjects With Specific Disease Symptoms
Dysentery
|
34.4 Percentage of subjects
Interval 20.6 to 50.4
|
28.6 Percentage of subjects
Interval 15.1 to 45.7
|
|
Percentage of Subjects With Specific Disease Symptoms
Shedding of S. sonnei 53G and […
|
46.9 Percentage of subjects
Interval 31.5 to 62.7
|
42.9 Percentage of subjects
Interval 26.9 to 60.0
|
|
Percentage of Subjects With Specific Disease Symptoms
≥1 stool and no moderate/severe diarrhea evidence
|
50.0 Percentage of subjects
Interval 34.4 to 65.6
|
60.7 Percentage of subjects
Interval 43.5 to 76.2
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Abdominal pain
|
50.0 Percentage of subjects
Interval 34.4 to 65.6
|
46.4 Percentage of subjects
Interval 30.1 to 63.4
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Abdominal cramps
|
53.1 Percentage of subjects
Interval 37.3 to 68.5
|
50.0 Percentage of subjects
Interval 33.3 to 66.7
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Gas
|
40.6 Percentage of subjects
Interval 26.0 to 56.7
|
57.1 Percentage of subjects
Interval 40.0 to 73.1
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Anorexia
|
43.8 Percentage of subjects
Interval 28.7 to 59.7
|
46.4 Percentage of subjects
Interval 30.1 to 63.4
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Nausea
|
34.4 Percentage of subjects
Interval 20.6 to 50.4
|
32.1 Percentage of subjects
Interval 17.9 to 49.4
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Headache
|
53.1 Percentage of subjects
Interval 37.3 to 68.5
|
60.7 Percentage of subjects
Interval 43.5 to 76.2
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Myalgia
|
34.4 Percentage of subjects
Interval 20.6 to 50.4
|
46.4 Percentage of subjects
Interval 30.1 to 63.4
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Malaise
|
46.9 Percentage of subjects
Interval 31.5 to 62.7
|
57.1 Percentage of subjects
Interval 40.0 to 73.1
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Arthralgia
|
28.1 Percentage of subjects
Interval 15.5 to 43.9
|
32.1 Percentage of subjects
Interval 17.9 to 49.4
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Fever
|
9.4 Percentage of subjects
Interval 2.6 to 22.5
|
17.9 Percentage of subjects
Interval 7.3 to 33.9
|
|
Percentage of Subjects With Specific Disease Symptoms
Any Vomiting
|
21.9 Percentage of subjects
Interval 10.7 to 37.2
|
7.1 Percentage of subjects
Interval 1.3 to 20.8
|
|
Percentage of Subjects With Specific Disease Symptoms
Intravenous fluid administration
|
0 Percentage of subjects
Interval 0.0 to 0.0
|
0 Percentage of subjects
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent.
The mean number of grade 3-5 stools (and standard deviation) were calculated per subject from challenge to discharge.
Outcome measures
| Measure |
S. Sonnei Group
n=32 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=28 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Mean Number of Grade 3-5 Stools Per Subject
|
28 grade 3-5 stools
Standard Deviation 13.0
|
13.9 grade 3-5 stools
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent.
Mean and standard deviation (SD) of weights were expressed in grams. The following measures were calculated: mean and SD of the weight of grade 3-5 stools calculated on all subjects (Weight/all subjects), mean and SD of the weight of grade 3-5 stools calculated on subjects with at least one grade 3-5 stool (Weight/subj.with at least 1 grade 3-5 stool), Cumulative mean and SD weight of grade 3-5 stools per subjects, accumulated from challenge to discharge (Cumulative weight/all subjects).
Outcome measures
| Measure |
S. Sonnei Group
n=32 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=28 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Weight of Grade 3-5 Stools
Weight/all subjects
|
87.4 Grams
Standard Deviation 68.3
|
91.3 Grams
Standard Deviation 54.7
|
|
Weight of Grade 3-5 Stools
Weight/subj. with at least 1 grade 3-5 stool
|
127.2 Grams
Standard Deviation 39.8
|
116.3 Grams
Standard Deviation 28.5
|
|
Weight of Grade 3-5 Stools
Cumulative weight/all subjects
|
1161.1 Grams
Standard Deviation 1416.9
|
766.9 Grams
Standard Deviation 884.9
|
SECONDARY outcome
Timeframe: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)Population: The analysis was not performed because less than 50% of subjects experienced the event (shigellosis) during the observation period. Therefore, the Median time to onset of shigellosis and 90% confidence interval (CI) could not be calculated in any of the groups.
Median time to onset of shigellosis was to be estimated with Kaplan-Meier method among subjects who received the challenge agent. The day associated to the first shigellosis was the time of onset of shigellosis. Subjects who did not have shigellosis were censored at the time on the day of discharge. Median time (in days) to onset of shigellosis and 90% confidence interval (CI) could not be calculated in any of the groups because less than 50% of subjects experienced the event (shigellosis) during the observation period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29)Population: The analysis is performed on Solicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, with valid data on solicited AEs and with the Subject Diary completed.
Solicited local AEs include: pain, erythema and induration at injection site. Any = occurrence of local adverse event regardless of intensity grade. Any erythema or induration at injection site is any symptom with a surface diameter greater than 25 millimeters.
Outcome measures
| Measure |
S. Sonnei Group
n=36 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Dose 1, Pain
|
29 Participants
|
12 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Dose 2, Pain
|
24 Participants
|
5 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Dose 1, Erythema
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Dose 2, Erythema
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Dose 1, Induration
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Dose 2, Induration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29)Population: The analysis is performed on Solicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, with valid data on solicited AEs and with the Subject Diary completed.
Solicited systemic AEs include: arthralgia, chills, fatigue, headache, malaise, myalgia, fever (oral temperature ≥ 38.0°C). Any = occurrence of systemic adverse event regardless of intensity and relation to study vaccination.
Outcome measures
| Measure |
S. Sonnei Group
n=36 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 1, Arthralgia
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 2, Arthralgia
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 1, Chills
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 2, Chills
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 1, Fatigue
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 2, Fatigue
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 1, Headache
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 2, Headache
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 1, Malaise
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 2, Malaise
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 1, Myalgia
|
15 Participants
|
8 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 2, Myalgia
|
9 Participants
|
7 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 1, Fever
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Systemic AEs
Dose 2, Fever
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 28-day period across doses (vaccine/placebo administered at Day 1 and Day 29)Population: The analysis is performed on the Unsolicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, with unsolicited AE data.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.
Outcome measures
| Measure |
S. Sonnei Group
n=36 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=34 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited AEs During the 28-day Post-vaccination Period
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: During the 28-day follow-up period after challenge (challenge administered at Day 57)Population: The analysis is performed on the Unsolicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, and the challenge agent administration, and with unsolicited AE data.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination and/or challenge agent administration.
Outcome measures
| Measure |
S. Sonnei Group
n=33 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=29 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited AEs During the 28-day Follow-up Period After Challenge
|
20 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to study end at Day 237Population: The analysis is performed on the Overall Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, and who are in the Solicited Safety Set and/or Unsolicited Safety Set.
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the study vaccination and/or challenge agent administration.
Outcome measures
| Measure |
S. Sonnei Group
n=36 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs
Any SAE(s)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs
Related SAE(s)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to study end at Day 237Population: The analysis is performed on the Overall Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, and who are in the Solicited Safety Set and/or Unsolicited Safety Set.
AESI are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Outcome measures
| Measure |
S. Sonnei Group
n=36 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects With Any Adverse Events of Special Interest (AESI) (i.e., Symptomatic Neutropenia)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 8, at Day 36 and at Day 237Population: The analysis is performed on the Exposed Set, which includes all enrolled subjects who received the study vaccination and with laboratory data for the specified time points.
Among hematological parameters assessed are: Basophils, Eosinophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Below = below the normal laboratory range defined for the specified laboratory parameter; Above = above the normal laboratory range defined for the specified laboratory parameter; Within = within the normal laboratory range defined for the specified laboratory parameter. Category naming has been defined as follows: Parameter, time point, range indicator at Baseline, range indicator at the specified time point: e.g.: "Basophils, Day 8, Within, Within ". Note: All subjects whose neutrophil value was below the threshold defined in the Protocol, at any time during the study, were re-tested until neutropenia resolution.
Outcome measures
| Measure |
S. Sonnei Group
n=36 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 8, Within, Below
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 8, Below, Above
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 36, Below, Below
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 36, Below, Within
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 36, Within, Below
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 36, Within, Within
|
29 Participants
|
29 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 36, Above, Within
|
—
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 237, Below, Below
|
3 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 237, Below, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 237, Within, Below
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 237, Within, Within
|
24 Participants
|
24 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 237, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 237, Above, Above
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 8, Below, Below
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 8, Within, Below
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 8, Within, Within
|
29 Participants
|
32 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 36, Below, Below
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 36, Below, Within
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 36, Within, Below
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 36, Within, Within
|
29 Participants
|
32 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 237, Below, Below
|
3 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 237, Within, Below
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hemoglobin, Day 237, Within, Within
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 8, Below, Below
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 8, Below, Within
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 8, Within, Below
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 8, Within, Within
|
28 Participants
|
28 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 8, Within, Above
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 8, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 36, Below, Below
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 36, Below, Within
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 36, Within, Below
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 36, Within, Within
|
28 Participants
|
27 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 36, Within, Above
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 36, Above, Above
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 237, Below, Below
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 237, Below, Within
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 237, Within, Below
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 237, Within, Within
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 237, Within, Above
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Leukocytes, Day 237, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 8, Unknown, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 8, Within, Below
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 8, Within, Within
|
33 Participants
|
34 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 8, Within, Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 36, Unknown, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 36, Below, Below
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 36, Within, Within
|
35 Participants
|
33 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 237, Unknown, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 237, Below, Below
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Lymphocytes, Day 237, Within, Within
|
28 Participants
|
27 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 8, Within, Within
|
27 Participants
|
25 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 8, Within, Above
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 8, Above, Within
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 8, Above, Above
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 36, Within, Within
|
25 Participants
|
25 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 36, Within, Above
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 36, Above, Within
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 36, Above, Above
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 237, Within, Within
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 237, Within, Above
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 237, Above, Within
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Monocytes, Day 237, Above, Above
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 8, Below, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 8, Within, Below
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 8, Within, Within
|
34 Participants
|
29 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 8, Within, Above
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 8, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 36, Below, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 36, Within, Below
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 36, Within, Within
|
33 Participants
|
31 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 36, Within, Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 36, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 237, Within, Below
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 237, Within, Within
|
28 Participants
|
25 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 237, Within, Above
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Neutrophils, Day 237, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 8, Below, Below
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 8, Within, Within
|
36 Participants
|
34 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 36, Below, Below
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 36, Within, Within
|
36 Participants
|
33 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 237, Below, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 237, Within, Below
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 237, Within, Within
|
29 Participants
|
25 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Platelets, Day 237, Within, Above
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 8, Within, Within
|
31 Participants
|
28 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 8, Within, Above
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 8, Above, Within
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 8, Above, Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 36, Within, Within
|
32 Participants
|
26 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 36, Within, Above
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 36, Above, Within
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 36, Above, Above
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 237, Within, Within
|
25 Participants
|
22 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 237, Within, Above
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Basophils, Day 237, Above, Within
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 8, Within, Within
|
35 Participants
|
34 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 8, Within, Above
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 8, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 36, Within, Within
|
36 Participants
|
32 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 36, Within, Above
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 36, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 237, Within, Within
|
29 Participants
|
27 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Eosinophils, Day 237, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 8, Below, Below
|
4 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 8, Below, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 8, Within, Within
|
29 Participants
|
31 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 8, Above, Within
|
—
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 36, Below, Below
|
4 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 36, Below, Within
|
1 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 36, Within, Below
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 36, Within, Within
|
29 Participants
|
30 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 36, Above, Within
|
—
|
2 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 237, Below, Below
|
3 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 237, Below, Within
|
2 Participants
|
—
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 237, Within, Below
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 237, Within, Within
|
22 Participants
|
25 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 237, Within, Above
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 237, Above, Within
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Erythrocytes, Day 237, Above, Above
|
—
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 8, Below, Below
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 8, Below, Within
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 8, Within, Below
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 8, Within, Within
|
29 Participants
|
31 Participants
|
|
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Hematocrit, Day 8, Above, Within
|
—
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 1 (pre-vaccination), at Day 8 (7 days after the first vaccination), at Day 29 (28 days after the first vaccination), at Day 36 (7 days after the second vaccination) and at Day 56 (27 days after the second vaccination)Population: The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points.
Anti-S. sonnei LPS IgG antibody concentrations are presented as geometric mean concentrations (GMCs), determined by Enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL). Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
Outcome measures
| Measure |
S. Sonnei Group
n=34 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=31 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination
Day 1
|
99.32 EU/mL
Interval 62.39 to 158.11
|
124.07 EU/mL
Interval 77.3 to 199.13
|
|
Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination
Day 8
|
229.18 EU/mL
Interval 135.69 to 387.09
|
128.24 EU/mL
Interval 81.43 to 201.96
|
|
Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination
Day 29
|
523.21 EU/mL
Interval 304.08 to 900.24
|
124.48 EU/mL
Interval 76.16 to 203.46
|
|
Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination
Day 36
|
577.86 EU/mL
Interval 345.36 to 966.9
|
123.57 EU/mL
Interval 77.31 to 197.5
|
|
Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination
Day 56
|
548.75 EU/mL
Interval 325.13 to 926.18
|
134.24 EU/mL
Interval 85.12 to 211.7
|
SECONDARY outcome
Timeframe: At Day 56 (pre-challenge), at Day 64 (7 days after challenge) and at Day 85 (28 days after challenge)Population: The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo and challenge agent, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points.
Anti-S. sonnei LPS IgG antibody concentrations are presented as GMCs, as determined by ELISA and expressed in EU/mL. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
Outcome measures
| Measure |
S. Sonnei Group
n=30 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=26 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Anti-S. Sonnei LPS IgG Antibody Concentrations at Pre-challenge and After Challenge
Day 56
|
529.4 EU/mL
Interval 296.83 to 944.2
|
150.59 EU/mL
Interval 90.55 to 250.42
|
|
Anti-S. Sonnei LPS IgG Antibody Concentrations at Pre-challenge and After Challenge
Day 64
|
537.92 EU/mL
Interval 295.66 to 978.71
|
216.11 EU/mL
Interval 132.83 to 351.61
|
|
Anti-S. Sonnei LPS IgG Antibody Concentrations at Pre-challenge and After Challenge
Day 85
|
1039.07 EU/mL
Interval 601.0 to 1796.46
|
810.97 EU/mL
Interval 419.53 to 1567.65
|
SECONDARY outcome
Timeframe: At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination)Population: The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points.
This antibody response cut-off was based on the results of the previous Phase I studies and estimated results of the median antibody titer after natural infection by S. sonnei. The threshold 121 EU/mL planned per protocol has been recalibrated to 268 EU/mL following an investigation of reliability of the ELISA assay. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
Outcome measures
| Measure |
S. Sonnei Group
n=34 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=31 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Subjects Achieving a Post-vaccination Anti-S. Sonnei LPS Concentration ≥ 268 EU/mL
Day 29
|
24 Participants
|
7 Participants
|
|
Number of Subjects Achieving a Post-vaccination Anti-S. Sonnei LPS Concentration ≥ 268 EU/mL
Day 56
|
24 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination)Population: The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points.
Seroresponse definition as reported in the protocol was assay specific and specifically related to assay, as run in Marburg Lab for the previous GVGH Shigella studies. This assay was further characterized and optimized before being used in GVGH for the current Phase 2b study. Since the assay used in current study is not comparable with the assay used in previous GVGH studies, the seroresponse definition is no longer appropriate (as it is valid only for Marburg assay). With the acknowledgment that seroresponse results are no longer meaningful, the study team choose to report the results for transparency. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination" timing.
Outcome measures
| Measure |
S. Sonnei Group
n=34 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=31 Participants
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Number of Seroresponders for Anti-S. Sonnei LPS
Day 29
|
32 Participants
|
0 Participants
|
|
Number of Seroresponders for Anti-S. Sonnei LPS
Day 56
|
31 Participants
|
0 Participants
|
Adverse Events
S. Sonnei Group
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
S. Sonnei Group
n=36 participants at risk
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 participants at risk
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Vascular disorders
Haematoma
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
Other adverse events
| Measure |
S. Sonnei Group
n=36 participants at risk
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
Placebo Group
n=35 participants at risk
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Ear and labyrinth disorders
Ear congestion
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Ear and labyrinth disorders
Ear pain
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
18/36 • Number of events 23 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
42.9%
15/35 • Number of events 18 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Diarrhoea
|
61.1%
22/36 • Number of events 23 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
62.9%
22/35 • Number of events 22 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
11.4%
4/35 • Number of events 4 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Flatulence
|
36.1%
13/36 • Number of events 13 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
45.7%
16/35 • Number of events 16 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Nausea
|
30.6%
11/36 • Number of events 11 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
28.6%
10/35 • Number of events 11 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
5.7%
2/35 • Number of events 2 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Toothache
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
7/36 • Number of events 7 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
11.4%
4/35 • Number of events 4 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
General disorders
Chills
|
33.3%
12/36 • Number of events 15 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
14.3%
5/35 • Number of events 7 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
General disorders
Fatigue
|
36.1%
13/36 • Number of events 18 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
34.3%
12/35 • Number of events 15 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
General disorders
Induration
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
General disorders
Injection site pain
|
86.1%
31/36 • Number of events 54 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
37.1%
13/35 • Number of events 17 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
General disorders
Malaise
|
52.8%
19/36 • Number of events 29 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
45.7%
16/35 • Number of events 24 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
General disorders
Pyrexia
|
11.1%
4/36 • Number of events 4 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
14.3%
5/35 • Number of events 5 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Infections and infestations
Cellulitis
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Infections and infestations
Fungal infection
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Infections and infestations
Influenza
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Infections and infestations
Tooth abscess
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.9%
5/36 • Number of events 5 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Anal injury
|
5.6%
2/36 • Number of events 2 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
5.7%
2/35 • Number of events 2 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
5.7%
2/35 • Number of events 2 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.3%
3/36 • Number of events 3 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
14.3%
5/35 • Number of events 5 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.6%
2/36 • Number of events 2 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Investigations
Neutrophil count decreased
|
5.6%
2/36 • Number of events 3 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
14.3%
5/35 • Number of events 7 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.9%
14/36 • Number of events 14 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
37.1%
13/35 • Number of events 13 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.4%
16/36 • Number of events 24 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
28.6%
10/35 • Number of events 14 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
11.4%
4/35 • Number of events 4 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
69.4%
25/36 • Number of events 35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
45.7%
16/35 • Number of events 28 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Nervous system disorders
Headache
|
61.1%
22/36 • Number of events 31 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
62.9%
22/35 • Number of events 29 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Nervous system disorders
Paraesthesia
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Nervous system disorders
Presyncope
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Psychiatric disorders
Insomnia
|
8.3%
3/36 • Number of events 3 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
8.6%
3/35 • Number of events 3 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/36 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 4 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
0.00%
0/35 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.8%
1/36 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
2.9%
1/35 • Number of events 1 • Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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