Trial Outcomes & Findings for Safety and Immunogenicity Study of Rift Valley Fever Vaccine (NCT NCT00584194)
NCT ID: NCT00584194
Last Updated: 2020-01-03
Results Overview
Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
278 participants
Primary outcome timeframe
12 months
Results posted on
2020-01-03
Participant Flow
278 subjects were enrolled at USAMRIID to participate
Participant milestones
| Measure |
TSI-GSD 200 RVF Vaccine
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Overall Study
STARTED
|
278
|
|
Overall Study
COMPLETED
|
143
|
|
Overall Study
NOT COMPLETED
|
135
|
Reasons for withdrawal
| Measure |
TSI-GSD 200 RVF Vaccine
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Overall Study
Other
|
135
|
Baseline Characteristics
Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Baseline characteristics by cohort
| Measure |
TSI-GSD 200 RVF Vaccine
n=153 Participants
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
TSI-GSD 200 RVF Vaccine: Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
153 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsCollect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
Outcome measures
| Measure |
TSI-GSD 200 RVF Vaccine
n=278 Participants
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Safety: All Incidences of Erythema
Mild
|
15 number of events
|
|
Safety: All Incidences of Erythema
Moderate
|
10 number of events
|
|
Safety: All Incidences of Erythema
Severe
|
0 number of events
|
SECONDARY outcome
Timeframe: 28 days after dose 3Population: Population is based on responders (defined as a subject achieving a PRNT80 \>1:40)
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)
Outcome measures
| Measure |
TSI-GSD 200 RVF Vaccine
n=102 Participants
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Immunogenicity: Geometric Mean Titers After 3rd Vaccination
Male: GMT
|
47.3 Titers
Interval 29.6 to 75.4
|
|
Immunogenicity: Geometric Mean Titers After 3rd Vaccination
Female: GMT
|
74.9 Titers
Interval 43.6 to 128.6
|
SECONDARY outcome
Timeframe: Before 6-month boosterPopulation: Population is based on responders (defined as a subject achieving a PRNT80 \>1:40)
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B
Outcome measures
| Measure |
TSI-GSD 200 RVF Vaccine
n=39 Participants
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Immunogenicity: Geometric Mean Titers Before 6-month Booster
Female: GMT
|
23.9 Titers
Interval 8.2 to 68.9
|
|
Immunogenicity: Geometric Mean Titers Before 6-month Booster
Male: GMT
|
8.5 Titers
Interval 4.7 to 15.3
|
SECONDARY outcome
Timeframe: at 12 monthsPopulation: Population is based on responders (defined as a subject achieving a PRNT80 \>1:40)
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Outcome measures
| Measure |
TSI-GSD 200 RVF Vaccine
n=24 Participants
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Immunogenicity: Geometric Mean Titers at 12 Months
Male: GMT
|
48.8 Titers
Interval 20.1 to 118.1
|
|
Immunogenicity: Geometric Mean Titers at 12 Months
Female: GMT
|
48.4 Titers
Interval 23.1 to 101.5
|
SECONDARY outcome
Timeframe: month 6 after dose 4Population: Population is based on responders (defined as a subject achieving a PRNT80 \>1:40)
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Outcome measures
| Measure |
TSI-GSD 200 RVF Vaccine
n=67 Participants
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Immunogenicity: Geometric Mean Titers After 6-month Booster
Male: GMT
|
211.8 Titers
Interval 140.5 to 319.3
|
|
Immunogenicity: Geometric Mean Titers After 6-month Booster
Female: GMT
|
189.0 Titers
Interval 128.0 to 279.0
|
Adverse Events
TSI-GSD 200 RVF Vaccine
Serious events: 11 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TSI-GSD 200 RVF Vaccine
n=153 participants at risk
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Surgical and medical procedures
Rotator cuff surgery
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Cyst exicision
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Loss of consciousness during physcial assault
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Thyroidectomy
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Obstructive sleep apnea surgery
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Back surgery
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Meniscus repair surgery
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Partial sigmoidectomy
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Laproscopic surgery for RLQ pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Left nephrectomy
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
Other adverse events
| Measure |
TSI-GSD 200 RVF Vaccine
n=153 participants at risk
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to \< 1:40.
|
|---|---|
|
Nervous system disorders
Headache
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Fatigue
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Sore throat
|
2.6%
4/153 • Number of events 4 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Malaise
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Bruising
|
3.9%
6/153 • Number of events 6 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Fever
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy nose
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
warm
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Lacerations
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Pain
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Axillary tenderness
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Swelling
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Cardiac disorders
Chest pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Light headedness
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Scratchy throat
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Abdominal cramping
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Head cold
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Blood and lymphatic system disorders
Swollen neck glands
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Admittance
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Blurred vision
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Immune system disorders
Hives
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Stomach ache
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Foggy head
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Neck swollen
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Bump on right arm
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Infections and infestations
Chest congestion
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Feeling faint
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Stiff neck
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Psychiatric disorders
Hoarseness
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Metabolism and nutrition disorders
Loss of appetite
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Blood and lymphatic system disorders
Tender lymph nodes
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Cardiac disorders
Tight chest
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Flashes of light
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
GI problems
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Knee injury
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Absence from work
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Pressure
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Sinus headache
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Stomach virus
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Renal and urinary disorders
Urination discomfort
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Ear and labyrinth disorders
Ear pressure
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Infections and infestations
Bronchitis
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Infections and infestations
Nail fungus
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Upper eyelid pain to touch
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Upper eyelid itchy
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Immune system disorders
Upper eyelid swollen
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Surgical and medical procedures
Rotator cuff screw removal
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Sweating
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Cardiac disorders
Bradycardia
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Infections and infestations
Pinkeye
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Migraine
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Itchy bumps on arms
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Eye trauma
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Infections and infestations
Abcess
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Abdomen pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Bil umbilial hernias
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Immune system disorders
Face swelling
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Investigations
Elevated B/P
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Investigations
URI
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Induration
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Tender at site
|
5.2%
8/153 • Number of events 8 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Warmth at site
|
2.6%
4/153 • Number of events 4 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Tenderness
|
2.0%
3/153 • Number of events 3 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Soreness
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Warm
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Axillary pain
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Metabolism and nutrition disorders
Edema
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.3%
2/153 • Number of events 2 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Hot at site
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Skin and subcutaneous tissue disorders
Redness
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
General disorders
Burning and pinching
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Tender to touch
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Burning sensation
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Pain at site
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Nervous system disorders
Tingling
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
|
Injury, poisoning and procedural complications
Swelling at site
|
0.65%
1/153 • Number of events 1 • Annuals done for 5 years
Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place