Trial Outcomes & Findings for A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX (NCT NCT00314145)
NCT ID: NCT00314145
Last Updated: 2012-12-06
Results Overview
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
820 participants
Primary outcome timeframe
Up to Day 60 post-first vaccination
Results posted on
2012-12-06
Participant Flow
Participants were enrolled and treated from 07 November 2005 to 15 November 2006 at 5 clinical centers in Australia and 5 clinical centers in the US.
A total of 820 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
JE-VAX®
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
|
|---|---|---|
|
Overall Study
STARTED
|
410
|
410
|
|
Overall Study
COMPLETED
|
389
|
381
|
|
Overall Study
NOT COMPLETED
|
21
|
29
|
Reasons for withdrawal
| Measure |
JE-VAX®
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
|
Overall Study
Lost to Follow-up
|
5
|
12
|
|
Overall Study
Physician Decision
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Sponsor Decision
|
2
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
Baseline characteristics by cohort
| Measure |
JE-VAX®
n=410 Participants
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
n=410 Participants
All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
|
Total
n=820 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
|
|
Age, Categorical
Between 18 and 65 years
|
410 Participants
n=5 Participants
|
410 Participants
n=7 Participants
|
820 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37.0 Years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
37.7 Years
STANDARD_DEVIATION 15.11 • n=7 Participants
|
37.4 Years
STANDARD_DEVIATION 14.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
203 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
207 Participants
n=5 Participants
|
290 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 60 post-first vaccinationPopulation: Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Outcome measures
| Measure |
JE-VAX®
n=365 Participants
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
n=346 Participants
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
|
|---|---|---|
|
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Day 44 (N = 0, 346)
|
NA Participants
Seroconversion was not assessed at this time point for this group.
|
324 Participants
|
|
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Day 60 (N = 365, 346)
|
273 Participants
|
343 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Pre-vaccination) up to 60 days post-first vaccinationPopulation: Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population).
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported. Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
Outcome measures
| Measure |
JE-VAX®
n=410 Participants
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
n=410 Participants
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
|
|---|---|---|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Pain
|
262 Participants
|
105 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Erythema
|
123 Participants
|
27 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Pruritus
|
107 Participants
|
29 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Swelling
|
85 Participants
|
15 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Hemorrhage
|
20 Participants
|
14 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Rash
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Edema
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Joint Pain
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Reaction
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Discomfort
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Joint Movement Impairment
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Injection Site Warmth
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Venipuncture Site Bruise
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Fatigue
|
131 Participants
|
152 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Malaise
|
113 Participants
|
113 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Chills
|
32 Participants
|
43 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Pyrexia
|
18 Participants
|
14 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Headache
|
190 Participants
|
193 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Myalgia
|
107 Participants
|
105 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Arthralgia
|
58 Participants
|
58 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Diarrhea
|
56 Participants
|
57 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Nausea
|
53 Participants
|
56 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Vomiting
|
15 Participants
|
13 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Rash
|
26 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to Day 60 post-first vaccinationPopulation: Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Outcome measures
| Measure |
JE-VAX®
n=365 Participants
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
n=346 Participants
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Day 44 (N = 0, 346)
|
NA Titers
Geometric mean titers were not assessed at this time point for this group.
|
312.3 Titers
Interval 255.1 to 382.3
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Day 60 (N = 365, 346)
|
37.4 Titers
Interval 32.5 to 42.9
|
1391.7 Titers
Interval 1156.6 to 1674.5
|
SECONDARY outcome
Timeframe: Day 60 post-first vaccinationPopulation: Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Outcome measures
| Measure |
JE-VAX®
n=365 Participants
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
n=346 Participants
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
|
|---|---|---|
|
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Titer < 10
|
63 Participants
|
3 Participants
|
|
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Titer 10 to < 20
|
29 Participants
|
0 Participants
|
|
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Titer 20 to < 40
|
51 Participants
|
4 Participants
|
|
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Titer 40 to < 160
|
151 Participants
|
18 Participants
|
|
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Titer 160 to < 640
|
63 Participants
|
76 Participants
|
|
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Titer 640 to < 2560
|
6 Participants
|
75 Participants
|
|
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Titer ≥ 2560
|
2 Participants
|
170 Participants
|
Adverse Events
JE-VAX®
Serious events: 3 serious events
Other events: 262 other events
Deaths: 0 deaths
ChimeriVax™-JE
Serious events: 2 serious events
Other events: 193 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JE-VAX®
n=410 participants at risk
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
n=410 participants at risk
All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
|
|---|---|---|
|
General disorders
Non Cardiac Chest Pain
|
0.00%
0/410 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
0.24%
1/410 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.24%
1/410 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
0.00%
0/410 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.24%
1/410 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
0.00%
0/410 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/410 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
0.24%
1/410 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Nervous system disorders
Multiple Sclerosis
|
0.00%
0/410 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
0.24%
1/410 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/410 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
0.24%
1/410 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Exacerbated
|
0.24%
1/410 • Number of events 1 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
0.00%
0/410 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
Other adverse events
| Measure |
JE-VAX®
n=410 participants at risk
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
|
ChimeriVax™-JE
n=410 participants at risk
All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
13.7%
56/410 • Number of events 80 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
13.9%
57/410 • Number of events 99 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Gastrointestinal disorders
Nausea
|
12.9%
53/410 • Number of events 96 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
13.7%
56/410 • Number of events 75 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
General disorders
Chills
|
7.8%
32/410 • Number of events 48 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
10.5%
43/410 • Number of events 68 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
General disorders
Fatigue
|
32.0%
131/410 • Number of events 399 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
37.1%
152/410 • Number of events 366 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
General disorders
Injection Site Pain
|
63.9%
262/410 • Number of events 804 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
25.6%
105/410 • Number of events 207 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
General disorders
Injection Site Erythema
|
30.0%
123/410 • Number of events 256 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
6.6%
27/410 • Number of events 35 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
General disorders
Injection Site Pruritus
|
26.1%
107/410 • Number of events 187 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
7.1%
29/410 • Number of events 46 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
General disorders
Injection Site Swelling
|
20.7%
85/410 • Number of events 149 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
3.7%
15/410 • Number of events 16 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
General disorders
Malaise
|
27.6%
113/410 • Number of events 248 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
27.6%
113/410 • Number of events 224 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.1%
107/410 • Number of events 228 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
25.6%
105/410 • Number of events 192 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.1%
58/410 • Number of events 99 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
14.1%
58/410 • Number of events 122 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Nervous system disorders
Headache
|
46.3%
190/410 • Number of events 546 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
47.1%
193/410 • Number of events 465 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.3%
26/410 • Number of events 36 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
5.6%
23/410 • Number of events 33 • Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER