Trial Outcomes & Findings for Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51 (NCT NCT00596102)

NCT ID: NCT00596102

Last Updated: 2014-07-30

Results Overview

first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

• Recruitment status: COMPLETED
• Target enrollment: 3258 participants
• Primary outcome timeframe: 24 months after the first vaccination
• Results posted on: 2014-07-30

Participant Flow

study participants were recruited from 44 study centers previously participating in study IC51-301 and IC51-302

Participant milestones

Measure	IC51 no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302	JE-VAX no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301	Placebo no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
Up to Month 6 STARTED	2283	338	637
Up to Month 6 COMPLETED	2283	338	637
Up to Month 6 NOT COMPLETED	0	0	0
Up to Month 60 STARTED	2283	338	637
Up to Month 60 COMPLETED	102	0	0
Up to Month 60 NOT COMPLETED	2181	338	637

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

Baseline characteristics by cohort

Measure	IC51 n=2283 Participants no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302	JE-VAX n=338 Participants no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301	Placebo n=637 Participants no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302	Total n=3258 Participants Total of all reporting groups
Age, Continuous	35.3 years STANDARD_DEVIATION 13.8 • n=5 Participants	42.3 years STANDARD_DEVIATION 14.1 • n=7 Participants	33.5 years STANDARD_DEVIATION 13.0 • n=5 Participants	35.6 years STANDARD_DEVIATION 13.9 • n=4 Participants
Sex: Female, Male Female	1274 Participants n=5 Participants	201 Participants n=7 Participants	365 Participants n=5 Participants	1840 Participants n=4 Participants
Sex: Female, Male Male	1009 Participants n=5 Participants	137 Participants n=7 Participants	272 Participants n=5 Participants	1418 Participants n=4 Participants
Race/Ethnicity, Customized Asian	38 participants n=5 Participants	1 participants n=7 Participants	16 participants n=5 Participants	55 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	101 participants n=5 Participants	35 participants n=7 Participants	25 participants n=5 Participants	161 participants n=4 Participants
Race/Ethnicity, Customized Caucasian	2076 participants n=5 Participants	288 participants n=7 Participants	574 participants n=5 Participants	2938 participants n=4 Participants
Race/Ethnicity, Customized Other	68 participants n=5 Participants	14 participants n=7 Participants	22 participants n=5 Participants	104 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 months after the first vaccination

Population: subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study

first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

Outcome measures

Measure	IC51 n=181 Participants no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)	81.8 percentage of subjects Interval 75.7 to 86.7

SECONDARY outcome

Timeframe: 6, 12, 36, 48 and 60 months after 1st vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 12, 36, 48 and 60 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 12, 24, 36, 48 and 60 months after 1st vaccination

Outcome measures

Outcome data not reported

Adverse Events

IC51 Month 6

Serious events: 15 serious events

Other events: 78 other events

Deaths: 0 deaths

JE-VAX

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 31 other events

Deaths: 0 deaths

IC51 Month 60

Serious events: 14 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	IC51 Month 6 n=2283 participants at risk no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6	JE-VAX n=338 participants at risk no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6	Placebo n=637 participants at risk no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6	IC51 Month 60 n=102 participants at risk no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60
Renal and urinary disorders Nephrolithiasis	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Gastrointestinal disorders Abdominal Pain	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Gastrointestinal disorders Abdominal Pain Lower	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Gastrointestinal disorders Appendix Disorder	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Gastrointestinal disorders Vomiting	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.30% 1/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Appendiceal Abscess	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Appendicitis	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Diverticulitis	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Pneumonia	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Pyelonephritis	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Sepsis	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Injury, poisoning and procedural complications Head Injury	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Injury, poisoning and procedural complications Joint Ligament Rupture	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Injury, poisoning and procedural complications Tibia Fructure	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Musculoskeletal and connective tissue disorders Synovial Cyst	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarinoma Pancreas	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Metastatic	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Nervous system disorders Central Nervous System Inflammation	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Respiratory, thoracic and mediastinal disorders Mediastinal Mass	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Surgical and medical procedures Meniscus Operation	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Surgical and medical procedures Tonsillectomy	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.30% 1/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Cardiac disorders Coronary Stenosis	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Abscess Soft Tissue	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Endometritis	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Tonsillitis	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.0% 2/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Investigations Smear Cervix Abnormal	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Musculoskeletal and connective tissue disorders Shoulder Pain	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.0% 2/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Musculoskeletal and connective tissue disorders Toe Deformity	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Nervous system disorders Post Herpetic Neuralgia	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Renal and urinary disorders Urethral Stricture	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Social circumstances Blood Donor	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.98% 1/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")

Other adverse events

Measure	IC51 Month 6 n=2283 participants at risk no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6	JE-VAX n=338 participants at risk no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6	Placebo n=637 participants at risk no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6	IC51 Month 60 n=102 participants at risk no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60
Infections and infestations Nasopharyngitis	3.4% 78/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	4.7% 16/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	4.9% 31/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	18.6% 19/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Endocrine disorders Hypothyroidism	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.59% 2/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Gastrointestinal disorders Diarrhoea	0.44% 10/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.47% 3/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Acute Tonsillitis	0.26% 6/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	1.2% 4/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Bronchitis	0.57% 13/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.59% 2/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.63% 4/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	5.9% 6/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Cystitis	0.48% 11/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.47% 3/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	6.9% 7/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Herpes Simplex	0.13% 3/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.16% 1/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Pneumonia	0.18% 4/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.31% 2/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Pyelonephritis	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Tonsillitis	0.26% 6/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.0% 2/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Infections and infestations Urinary Tract Infection	0.74% 17/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.59% 2/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.94% 6/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	3.9% 4/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Musculoskeletal and connective tissue disorders Arthralgia	0.26% 6/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.47% 3/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	3.9% 4/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Musculoskeletal and connective tissue disorders Back Pain	0.57% 13/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.30% 1/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.47% 3/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Musculoskeletal and connective tissue disorders Shoulder Pain	0.26% 6/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.47% 3/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Nervous system disorders Headache	1.8% 42/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.30% 1/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	1.1% 7/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	3.9% 4/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Psychiatric disorders Depression	0.22% 5/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.59% 2/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	3.9% 4/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Surgical and medical procedures Dental Implantation	0.04% 1/2283 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/338 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	0.00% 0/637 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")	2.9% 3/102 • all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")

Additional Information

Katrin Dubischar-Kastner

Valneva Austria GmbH

Phone: +43 1 20620

Email: info@valneva.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER