Trial Outcomes & Findings for Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis (NCT NCT02374814)
NCT ID: NCT02374814
Last Updated: 2022-06-13
Results Overview
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
1 month post first vaccination
Results posted on
2022-06-13
Participant Flow
One subject in group 4 was lost to follow up prior to receiving vaccine.
Participant milestones
| Measure |
Rabies Vaccine IM 3 Dose
Rabies vaccine: 1.0 ml delivered Intramuscularly (IM) on day 0, 7, 21 and 365.
|
Rabies Vaccine ID 3 Dose
Rabies vaccine: 0.1 ml of rabies vaccine delivered intradermal (ID) on days 0, 7, and 21 with a 1.0ml boost delivered IM on day 365.
|
Rabies Vaccine IM 2 Dose
Rabies vaccine: 1.0ml delivered IM on day 0, 7 and 365.
|
Rabies Vaccine ID 2 Dose
Rabies vaccine: 0.1ml delivered on day 0 and 7 with a 1.0ml IM boost on day 365
|
Placebo IM 1 Dose
Placebo: 1.0ml delivered IM on day 0
|
Placebo ID 1 Dose
Placebo: 0.1ml delivered on day 0
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
11
|
6
|
6
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
9
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Rabies Vaccine IM 3 Dose
Rabies vaccine: 1.0 ml delivered Intramuscularly (IM) on day 0, 7, 21 and 365.
|
Rabies Vaccine ID 3 Dose
Rabies vaccine: 0.1 ml of rabies vaccine delivered intradermal (ID) on days 0, 7, and 21 with a 1.0ml boost delivered IM on day 365.
|
Rabies Vaccine IM 2 Dose
Rabies vaccine: 1.0ml delivered IM on day 0, 7 and 365.
|
Rabies Vaccine ID 2 Dose
Rabies vaccine: 0.1ml delivered on day 0 and 7 with a 1.0ml IM boost on day 365
|
Placebo IM 1 Dose
Placebo: 1.0ml delivered IM on day 0
|
Placebo ID 1 Dose
Placebo: 0.1ml delivered on day 0
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis
Baseline characteristics by cohort
| Measure |
Rabies Vaccine IM 3 Dose
n=12 Participants
This is standard FDA approved schedule
Rabies vaccine: Compare dose schedule and route of administration
|
Rabies Vaccine ID 3 Dose
n=12 Participants
This is using alternative administration method
Rabies vaccine: Compare dose schedule and route of administration
|
Rabies Vaccine IM 2 Dose
n=12 Participants
This is using alternative dose schedule
Rabies vaccine: Compare dose schedule and route of administration
|
Rabies Vaccine ID 2 Dose
n=11 Participants
This is using alternative dose schedule and administration
Rabies vaccine: Compare dose schedule and route of administration
|
Placebo IM 1 Dose
n=6 Participants
Albumin and saline comparator
Placebo: Placebo
|
Placebo ID 1 Dose
n=6 Participants
Albumin and saline comparator
Placebo: Placebo
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
31.7 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
29.3 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
32.3 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
31.8 Years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
38.5 Years
STANDARD_DEVIATION 15.3 • n=21 Participants
|
35.7 Years
STANDARD_DEVIATION 10.6 • n=8 Participants
|
32.4 Years
STANDARD_DEVIATION 10.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
11 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
59 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1 month post first vaccinationPopulation: Placebo groups were used for adverse event data collection only. It was not expected that placebo group would elicit any antibody titer to rabies. Samples in groups 5 and 6 were not analyzed for primary or secondary outcome measures.
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus
Outcome measures
| Measure |
Rabies Vaccine IM 3 Dose
n=12 Participants
Rabies vaccine:
Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365.
|
Rabies Vaccine ID 3 Dose
n=12 Participants
Rabies vaccine:
Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365.
|
Rabies Vaccine IM 2 Dose
n=12 Participants
Rabies vaccine:
Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365.
|
Rabies Vaccine ID 2 Dose
n=11 Participants
Rabies vaccine:
Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365.
|
Placebo IM 1 Dose
Albumin and saline comparator
Placebo: A single 1mL intramuscular injection at day 0
|
Placebo ID 1 Dose
Albumin and saline comparator
Placebo: A single intradermal injection of 0.1mL at day 0
|
|---|---|---|---|---|---|---|
|
Protective Humoral Immune Response at 1 Month Post First Vaccination.
|
12 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 months post first vaccinationPopulation: One subject in each of groups 1, 2, and 4 were lost to follow up prior to vaccination boost. Placebo groups were used for adverse event data collection only. It was not expected that placebo group would elicit any antibody titer to rabies. Samples in groups 5 and 6 were not analyzed for primary or secondary outcome measures.
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus 12 months post vaccinations (prior to boost).
Outcome measures
| Measure |
Rabies Vaccine IM 3 Dose
n=11 Participants
Rabies vaccine:
Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365.
|
Rabies Vaccine ID 3 Dose
n=11 Participants
Rabies vaccine:
Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365.
|
Rabies Vaccine IM 2 Dose
n=12 Participants
Rabies vaccine:
Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365.
|
Rabies Vaccine ID 2 Dose
n=10 Participants
Rabies vaccine:
Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365.
|
Placebo IM 1 Dose
Albumin and saline comparator
Placebo: A single 1mL intramuscular injection at day 0
|
Placebo ID 1 Dose
Albumin and saline comparator
Placebo: A single intradermal injection of 0.1mL at day 0
|
|---|---|---|---|---|---|---|
|
Protective Humoral Immune Response 12 Months Post First Vaccination.
|
7 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 13 months post first vaccinationPopulation: One subject in group 3 and one in 4 withdrew consent not due to adverse events. Placebo groups were used for adverse event data collection only. It was not expected that placebo group would elicit any antibody titer to rabies. Samples in groups 5 and 6 were not analyzed for primary or secondary outcome measures.
Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus at 7 days post boost.
Outcome measures
| Measure |
Rabies Vaccine IM 3 Dose
n=11 Participants
Rabies vaccine:
Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365.
|
Rabies Vaccine ID 3 Dose
n=11 Participants
Rabies vaccine:
Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365.
|
Rabies Vaccine IM 2 Dose
n=11 Participants
Rabies vaccine:
Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365.
|
Rabies Vaccine ID 2 Dose
n=9 Participants
Rabies vaccine:
Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365.
|
Placebo IM 1 Dose
Albumin and saline comparator
Placebo: A single 1mL intramuscular injection at day 0
|
Placebo ID 1 Dose
Albumin and saline comparator
Placebo: A single intradermal injection of 0.1mL at day 0
|
|---|---|---|---|---|---|---|
|
Protective Humoral Immune Response 7 Days Post Booster at 12 Months Post First Vaccination.
|
11 Participants
|
11 Participants
|
11 Participants
|
9 Participants
|
—
|
—
|
Adverse Events
Rabies Vaccine IM 3 Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Rabies Vaccine ID 3 Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Rabies Vaccine IM 2 Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Rabies Vaccine ID 2 Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo IM 1 Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo ID 1 Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rabies Vaccine IM 3 Dose
n=12 participants at risk
Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365
|
Rabies Vaccine ID 3 Dose
n=12 participants at risk
Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365
|
Rabies Vaccine IM 2 Dose
n=12 participants at risk
Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365
|
Rabies Vaccine ID 2 Dose
n=11 participants at risk
Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365
|
Placebo IM 1 Dose
n=6 participants at risk
Albumin and saline comparator
Intramuscular injection: 1ml
|
Placebo ID 1 Dose
n=6 participants at risk
Albumin and saline comparator
Intradermal injection: 0.1ml
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
58.3%
7/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
91.7%
11/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
50.0%
6/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
90.9%
10/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
16.7%
1/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
General disorders
Fatigue
|
16.7%
2/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
9.1%
1/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
General disorders
Flu-like symptoms
|
16.7%
2/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
27.3%
3/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
General disorders
Malaise
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
General disorders
Fever
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
16.7%
2/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
18.2%
2/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
9.1%
1/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
9.1%
1/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Blood and lymphatic system disorders
Lymph node pain
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
9.1%
1/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Reproductive system and breast disorders
Menorrhagia
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
8.3%
1/12 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/11 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
0.00%
0/6 • 372 days for all groups (1-4) receiving rabies vaccine; 7 days for groups 5-6 receiving control
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place