Trial Outcomes & Findings for Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine (NCT NCT00584805)
NCT ID: NCT00584805
Last Updated: 2019-09-24
Results Overview
Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
5 years
Results posted on
2019-09-24
Participant Flow
138 subjects were enrolled at Special Immunizations Clinic, Division of Medicine, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD
Participant milestones
| Measure |
Vaccination
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
|---|---|
|
Overall Study
STARTED
|
138
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
99
|
Reasons for withdrawal
| Measure |
Vaccination
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
|---|---|
|
Overall Study
No longer at risk of exposure
|
39
|
|
Overall Study
Relocation
|
36
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Non-compliance
|
1
|
|
Overall Study
Lost to follow up
|
3
|
|
Overall Study
Screen failures
|
2
|
Baseline Characteristics
Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Baseline characteristics by cohort
| Measure |
Vaccination
n=138 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
|---|---|
|
Age, Continuous
|
39.0 Years of age
STANDARD_DEVIATION 10.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race : Other
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
138 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Only observations or specimens collected according to the protocol were included in the analyses
Subject response rates for PRNT80 titers for vaccinations and all boosters. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population. Four to 5 weeks for primary vaccinations (3) and up to four boost doses in 1 year period for a total duration of up to 5 years (anticipated duration of study execution).
Outcome measures
| Measure |
Vaccination
n=138 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
Vaccination - Booster
Inactivated, Dried, TSI-GSD 104, EEE
|
|---|---|---|
|
Subject Response Rates for PRNT80 Titers
Post dose 2: Day 21-35
|
39 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Pre-month 6
|
28 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Post month 6, Day 21-35
|
48 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Post booster 1, Day 21-35
|
79 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Post booster 2, Day 21-35
|
24 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Post booster 3, Day 21-35
|
9 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Post booster 4, Day 21-35
|
7 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Post booster 5, Day 21-35
|
3 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Annual (11-13 months)
|
37 Participants
|
—
|
|
Subject Response Rates for PRNT80 Titers
Closeout
|
75 Participants
|
—
|
PRIMARY outcome
Timeframe: Post dose 2, days 21-35Population: Only observations or specimens collected according to the protocol were included in the analyses
Subject response rates for PRNT80 titers for post dose 2, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Outcome measures
| Measure |
Vaccination
n=138 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
Vaccination - Booster
Inactivated, Dried, TSI-GSD 104, EEE
|
|---|---|---|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Responders · Year: 2008
|
8 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Responders · Year: 2009
|
4 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Responders · Year: 2010
|
10 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Responders · Year: 2011
|
12 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Responders · Year: 2013
|
5 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Responders · Year: 2014
|
2 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Non-responders · Year: 2008
|
14 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Non-responders · Year: 2009
|
6 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Non-responders · Year: 2010
|
3 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Non-responders · Year: 2011
|
0 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Non-responders · Year: 2013
|
3 Participants
|
—
|
|
Response Rates of Post Dose 2: Day 21-35 PRNT80 Titers
Non-responders · Year: 2014
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Pre-month 6Population: Only observations or specimens collected according to the protocol were included in the analyses
Subject response rates for PRNT80 titers of pre-month 6. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Outcome measures
| Measure |
Vaccination
n=138 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
Vaccination - Booster
Inactivated, Dried, TSI-GSD 104, EEE
|
|---|---|---|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Responders · Year: 2008
|
7 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Responders · Year: 2009
|
3 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Responders · Year: 2010
|
8 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Responders · Year: 2011
|
6 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Responders · Year: 2013
|
3 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Responders · Year: 2014
|
1 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Non-responders · Year: 2008
|
13 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Non-responders · Year: 2009
|
6 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Non-responders · Year: 2010
|
4 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Non-responders · Year: 2011
|
4 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Non-responders · Year: 2013
|
5 Participants
|
—
|
|
Response Rates of Pre-Month 6 PRNT80 Titers
Non-responders · Year: 2014
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Post month 6, days 21-35Population: Only observations or specimens collected according to the protocol were included in the analyses
Subject response rates for PRNT80 titers for post month 6, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Outcome measures
| Measure |
Vaccination
n=138 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
Vaccination - Booster
Inactivated, Dried, TSI-GSD 104, EEE
|
|---|---|---|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2014
|
6 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2008
|
2 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2009
|
16 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2010
|
9 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2011
|
11 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2012
|
2 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2013
|
1 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Responders · Year: 2015
|
2 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2008
|
0 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2009
|
8 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2010
|
1 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2011
|
1 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2012
|
0 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2013
|
0 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2014
|
1 Participants
|
—
|
|
Response Rates of Post Month 6: Day 21-35 PRNT80 Titers
Non-responders · Year: 2015
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Post booster 1, days 21-35Population: Only observations or specimens collected according to the protocol were included in the analyses
Subject response rates for PRNT80 titers for post booster 1, days 21-35. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Outcome measures
| Measure |
Vaccination
n=138 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
Vaccination - Booster
Inactivated, Dried, TSI-GSD 104, EEE
|
|---|---|---|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Responders · Year: 2008
|
34 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Responders · Year: 2009
|
23 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Responders · Year: 2010
|
11 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Responders · Year: 2011
|
3 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Responders · Year: 2013
|
6 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Responders · Year: 2014
|
3 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Responders · Year: 2015
|
2 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Non-responders · Year: 2008
|
10 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Non-responders · Year: 2009
|
13 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Non-responders · Year: 2010
|
1 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Non-responders · Year: 2011
|
0 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Non-responders · Year: 2013
|
0 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Non-responders · Year: 2014
|
1 Participants
|
—
|
|
Response Rates of Post Booster 1: Day 21-35 PRNT80 Titers
Non-responders · Year: 2015
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Months 11-13Population: Only observations or specimens collected according to the protocol were included in the analyses
Subject annual response rates for PRNT80 titers for months 11-13. The per-protocol population was used for immunogenicity analyses. Only subjects who were vaccinated according to the schedule defined in the protocol were included in the per-protocol population. Only observations or specimens collected according to the protocol were included in the analyses using the per protocol population. If a subject received one or more treatments out of compliance with the protocol schedule, any observations or specimens collected after the out-of-compliance treatment were excluded from the analyses using the per-protocol population.
Outcome measures
| Measure |
Vaccination
n=138 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
Vaccination - Booster
Inactivated, Dried, TSI-GSD 104, EEE
|
|---|---|---|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Non-responders · Year: 2010
|
0 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Responders · Year: 2008
|
11 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Responders · Year: 2009
|
3 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Responders · Year: 2010
|
12 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Responders · Year: 2011
|
6 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Responders · Year: 2013
|
5 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Responders · Year: 2014
|
2 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Non-responders · Year: 2008
|
4 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Non-responders · Year: 2009
|
6 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Non-responders · Year: 2011
|
2 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Non-responders · Year: 2013
|
2 Participants
|
—
|
|
Response Rates of Annual (11-13 Months) PRNT80 Titers
Non-responders · Year: 2014
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: vaccination/booster days 0-28 for up to 5 yearsNumber of subjects of who experienced and didn't experience local and systemic adverse events after vaccination and booster.
Outcome measures
| Measure |
Vaccination
n=67 Participants
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
Vaccination - Booster
n=132 Participants
Inactivated, Dried, TSI-GSD 104, EEE
|
|---|---|---|
|
Number of Subject Experiencing Local and Systemic Adverse Events
No AEs: Male subjects
|
19 Participants
|
47 Participants
|
|
Number of Subject Experiencing Local and Systemic Adverse Events
No AEs: Female subjects
|
10 Participants
|
29 Participants
|
|
Number of Subject Experiencing Local and Systemic Adverse Events
Had AEs: Male subjects
|
18 Participants
|
30 Participants
|
|
Number of Subject Experiencing Local and Systemic Adverse Events
Had AEs: Female subjects
|
20 Participants
|
26 Participants
|
Adverse Events
Vaccination/Booster
Serious events: 5 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccination/Booster
n=136 participants at risk
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
|---|---|
|
Cardiac disorders
Atrial febrillation
|
0.74%
1/136 • Number of events 2 • vaccination and booster days 0-28 for up to 5 years
|
|
Congenital, familial and genetic disorders
Biscuspid aortic valve
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Infections and infestations
Viral pericarditis
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Cardiac disorders
Coronary artery disease
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
Other adverse events
| Measure |
Vaccination/Booster
n=136 participants at risk
Inactivated, Dried, TSI-GSD 104, EEE
Inactivated, Dried, TSI-GSD 104, EEE: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Abdominal destension
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Immune system disorders
Allergic rhinitis
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Amoebic dysentery
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Eye disorders
Angle closure glaucoma
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Cardiac disorders
Atrial flutter
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/136 • Number of events 2 • vaccination and booster days 0-28 for up to 5 years
|
|
Cardiac disorders
Bicuspic aortic valve
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Infections and infestations
Bronchitis
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chills
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Colon cancer
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Infections and infestations
Conjunctivitis viral
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Cardiac disorders
Coronary artery disease
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
6/136 • Number of events 6 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Diarrhea haemorrhagic
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Ear and labyrinth disorders
Ear infection
|
1.5%
2/136 • Number of events 2 • vaccination and booster days 0-28 for up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
General disorders
Fatigue
|
14.0%
19/136 • Number of events 19 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Nervous system disorders
Headache
|
15.4%
21/136 • Number of events 21 • vaccination and booster days 0-28 for up to 5 years
|
|
General disorders
Hyperhidrosis
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
General disorders
Injection site anaesthesia
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site erythema
|
11.8%
16/136 • Number of events 16 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site haematoma
|
7.4%
10/136 • Number of events 10 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site induration
|
3.7%
5/136 • Number of events 5 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site pain
|
8.8%
12/136 • Number of events 12 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site paraesthesia
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site pruritus
|
6.6%
9/136 • Number of events 9 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site swelling
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Injection site warmth
|
1.5%
2/136 • Number of events 2 • vaccination and booster days 0-28 for up to 5 years
|
|
Psychiatric disorders
Insomnia
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
General disorders
Lethargy
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
General disorders
Malaise
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Ear and labyrinth disorders
Middle ear infection
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Nervous system disorders
Migraine
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.5%
2/136 • Number of events 2 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
7/136 • Number of events 7 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
5.1%
7/136 • Number of events 7 • vaccination and booster days 0-28 for up to 5 years
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Infections and infestations
Oral herpes
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
11.0%
15/136 • Number of events 15 • vaccination and booster days 0-28 for up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
General disorders
Pyrexia
|
5.1%
7/136 • Number of events 7 • vaccination and booster days 0-28 for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
5/136 • Number of events 5 • vaccination and booster days 0-28 for up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.9%
8/136 • Number of events 8 • vaccination and booster days 0-28 for up to 5 years
|
|
Nervous system disorders
Sinus headache
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
3.7%
5/136 • Number of events 5 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
|
Nervous system disorders
Tension headache
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
11.0%
15/136 • Number of events 15 • vaccination and booster days 0-28 for up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Vascular disorders
Vessel puncture site haematoma
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Cardiac disorders
Viral pericarditis
|
0.74%
1/136 • Number of events 1 • vaccination and booster days 0-28 for up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
3/136 • Number of events 3 • vaccination and booster days 0-28 for up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place