Trial Outcomes & Findings for Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults (NCT NCT02741128)
NCT ID: NCT02741128
Last Updated: 2024-07-19
Results Overview
An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and case report form (CRF) in terms of diagnosis and/or onset window post-vaccination.
COMPLETED
PHASE2
133 participants
Within 30 minutes after each injection
2024-07-19
Participant Flow
The study was conducted at 4 centers in Brazil from 06 November 2019 to 07Jul 2021.
A total of 133 participants were randomized in 2:1 ratio of which 132 participants received vaccination.
Participant milestones
| Measure |
CYD Dengue Vaccine
Participants were administered a single dose of subcutaneous (SC) injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
44
|
|
Overall Study
Vaccinated
|
88
|
44
|
|
Overall Study
COMPLETED
|
82
|
43
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine
Participants were administered a single dose of subcutaneous (SC) injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine
n=88 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 7.60 • n=88 Participants
|
36.3 years
STANDARD_DEVIATION 7.88 • n=44 Participants
|
36.7 years
STANDARD_DEVIATION 7.67 • n=132 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=88 Participants
|
20 Participants
n=44 Participants
|
51 Participants
n=132 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=88 Participants
|
24 Participants
n=44 Participants
|
81 Participants
n=132 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Within 30 minutes after each injectionPopulation: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.
An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and case report form (CRF) in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=88 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With Unsolicited Systemic Adverse Event (AE)
|
0 percentage of participants
Interval 0.0 to 4.1
|
0 percentage of participants
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: Up to 7 days after each injectionPopulation: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected. Only those participants with data available were analyzed.
An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. A solicited reaction was an expected adverse reaction (AR) observed and reported under the conditions pre-listed in the protocol and CRF and included pain, erythema, and swelling. Injection site reaction was an AR at and around the injection site. Injection site reactions were commonly inflammatory reactions.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=87 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-Site Reactions
|
19.5 percentage of participants
Interval 11.8 to 29.4
|
29.5 percentage of participants
Interval 16.8 to 45.2
|
PRIMARY outcome
Timeframe: Up to 14 days after each injectionPopulation: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included headache, fever, localized or topical manifestations that were not associated with the vaccination or administration site.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=88 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Reactions
|
61.4 percentage of participants
Interval 50.4 to 71.6
|
72.7 percentage of participants
Interval 57.2 to 85.0
|
PRIMARY outcome
Timeframe: Up to 28 days after each injectionPopulation: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and CRF in terms of diagnosis and/or onset window post-vaccination. An AESI was one of scientific and medical concern specific to the study vaccine, for which ongoing monitoring, and rapid communication by the Investigator to the Sponsor was appropriate. The following were considered as serious AESI: serious hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination; serious viscerotropic disease occurring in all participants within 30 days after vaccination; serious neurotropic disease occurring in all participants within 30 days after vaccination; serious dengue disease requiring hospitalization occurring in all participants at any time during the study. The following were considered as non-serious AESIs, hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=88 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With Unsolicited AE, Serious and Non-Serious AEs of Special Interest (AESIs)
Unsolicited AE
|
55.7 percentage of participants
Interval 44.7 to 66.3
|
65.9 percentage of participants
Interval 50.1 to 79.5
|
|
Percentage of Participants With Unsolicited AE, Serious and Non-Serious AEs of Special Interest (AESIs)
Serious AESI
|
0 percentage of participants
Interval 0.0 to 4.1
|
0 percentage of participants
Interval 0.0 to 8.0
|
|
Percentage of Participants With Unsolicited AE, Serious and Non-Serious AEs of Special Interest (AESIs)
Non-serious AESI
|
4.5 percentage of participants
Interval 1.3 to 11.2
|
2.3 percentage of participants
Interval 0.1 to 12.0
|
PRIMARY outcome
Timeframe: From the date of randomization until 6-month safety follow-up (approximately 38 months)Population: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.
An AE was any untoward medical occurrence in a participant administered study vaccine and which does not necessarily have a causal relationship. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Hospitalized VCD cases were defined as an acute febrile illness with diagnosis of dengue requiring hospitalization. The confirmatory dengue diagnosis was performed through virological detection.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=88 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With Serious AEs (SAEs) and Hospitalized Virologically-Confirmed Dengue (VCD) Cases
SAE
|
13.6 percentage of participants
Interval 7.2 to 22.6
|
15.9 percentage of participants
Interval 6.6 to 30.1
|
|
Percentage of Participants With Serious AEs (SAEs) and Hospitalized Virologically-Confirmed Dengue (VCD) Cases
Hospitalized VCD Cases
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 28 days after each injectionPopulation: The Full analysis set consisted of participants who received either CYD dengue vaccine or placebo and had blood sample drawn and valid post-injection serology results. Only data from the participants analyzed were reported.
Dengue neutralizing antibody levels were measured by PRNT50. Serial, 2-fold dilutions of serum to be tested (previously heat-inactivated) were mixed with a constant challenge-dose of each dengue virus serotype 1, 2, 3 or 4. The presence of dengue virus infected cells was indicated by formation of plaques. A reduction in virus infectivity due to neutralization by antibody present in serum samples was detected. The reported value represented the highest dilution of serum at which \>= 50% of dengue challenge virus (in plaque counts) was neutralized when compared to the mean viral plaque count in the negative control wells which represented the 100% virus load.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=87 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 1, Day 0
|
176 Titer
Interval 113.0 to 273.0
|
256 Titer
Interval 142.0 to 464.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 1, Day 28
|
589 Titer
Interval 394.0 to 881.0
|
227 Titer
Interval 131.0 to 393.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 1, Day 211
|
508 Titer
Interval 350.0 to 736.0
|
260 Titer
Interval 151.0 to 449.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 1, Day 393
|
535 Titer
Interval 363.0 to 789.0
|
252 Titer
Interval 142.0 to 447.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 2, Day 0
|
263 Titer
Interval 177.0 to 390.0
|
426 Titer
Interval 275.0 to 658.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 2, Day 28
|
979 Titer
Interval 750.0 to 1279.0
|
411 Titer
Interval 288.0 to 586.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 2, Day 211
|
834 Titer
Interval 639.0 to 1089.0
|
496 Titer
Interval 331.0 to 741.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 2, Day 393
|
845 Titer
Interval 623.0 to 1146.0
|
532 Titer
Interval 368.0 to 771.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 3, Day 0
|
142 Titer
Interval 98.2 to 205.0
|
233 Titer
Interval 140.0 to 389.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 3, Day 28
|
526 Titer
Interval 390.0 to 709.0
|
202 Titer
Interval 117.0 to 349.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 3, Day 211
|
383 Titer
Interval 285.0 to 516.0
|
204 Titer
Interval 123.0 to 336.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 3, Day 393
|
310 Titer
Interval 237.0 to 404.0
|
179 Titer
Interval 110.0 to 292.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 4, Day 0
|
67.4 Titer
Interval 47.4 to 95.2
|
80.2 Titer
Interval 49.5 to 130.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 4, Day 28
|
489 Titer
Interval 376.0 to 635.0
|
89.7 Titer
Interval 58.3 to 138.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 4, Day 211
|
414 Titer
Interval 321.0 to 535.0
|
109 Titer
Interval 65.3 to 183.0
|
|
Geometric Mean Titers of Neutralizing Antibody Levels Against Each of the 4 Parental Dengue Virus Strains
Serotype 4, Day 393
|
354 Titer
Interval 281.0 to 445.0
|
86.1 Titer
Interval 54.0 to 137.0
|
SECONDARY outcome
Timeframe: At 7 and 14 days post-injection 1Population: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected. Only data from the participants analyzed were reported.
The percentage of participants with detected and quantified CYD dengue vaccinal viremia, i.e above the detection level as assessed by reverse transcription-polymerase chain reaction (RT-PCR) and for each of the 4 dengue serotypes after the first CYD dengue vaccine injection has been reported. Four RT-PCRs were used to perform quantitation and serotype identification of post-vaccinal serotype-specific dengue vaccine viremia from serum samples displaying a positive yellow fever (YF) RT-PCR result. The assay was performed only for YT RT-PCR-positive samples.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=12 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 1, Detectable viremia, Day 7
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 1, Quantified viremia, Day 7
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 2, Detectable viremia, Day 7
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 2, Quantified viremia, Day 7
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 3, Detectable viremia, Day 7
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 3, Quantified viremia, Day 7
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 4, Detectable viremia, Day 7
|
41.7 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 4, Quantified viremia, Day 7
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 1, Detectable viremia, Day 14
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 1, Quantified viremia, Day 14
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 2, Detectable viremia, Day 14
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 2, Quantified viremia, Day 14
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 3, Detectable viremia, Day 14
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 3, Quantified viremia, Day 14
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 4, Detectable viremia, Day 14
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Detected and Quantified CYD Dengue Vaccinal Viremia
Serotype 4, Quantified viremia, Day 14
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Day 28 to Day 393 (28 days after each injection)Population: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected. Only those participants with data available were analyzed.
A decrease in CD4 count greater than 30 % assessed 28 days post-injection compared to the pre-injection value, not explained by non-adherence to antiretroviral therapy (ART) and not explained by any other possible etiology, and confirmed by a second test taken 4 weeks after the first (ie, approximately 2 months post-injection) showing the same value/trend.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=87 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With Clusters of Differentiation 4 (CD4) Count Decrease
|
6.9 percentage of participants
Interval 2.6 to 14.4
|
2.3 percentage of participants
Interval 0.1 to 12.0
|
SECONDARY outcome
Timeframe: From Day 28 to Day 393 (28 days after each injection)Population: The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.
A confirmed HIV viral load increase was defined as plasma HIV-1 RNA \>1000 copies/milliliter (mL) 28 days post-injection after having been undetectable (\< 50 copies/mL) pre-injection, not explained by non-adherence to ART and not explained by any other possible etiology and confirmed by a second test taken 4 weeks after the first (i.e, approximately 2 months post-injection) showing the same value/trend.
Outcome measures
| Measure |
CYD Dengue Vaccine
n=88 Participants
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 Participants
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Percentage of Participants With Confirmed Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Viral Load Increase
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
CYD Dengue Vaccine
Placebo
Serious adverse events
| Measure |
CYD Dengue Vaccine
n=88 participants at risk
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 participants at risk
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/88 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
2.3%
1/44 • Number of events 1 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Infections and infestations
Covid-19
|
1.1%
1/88 • Number of events 1 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
0.00%
0/44 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/88 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
2.3%
1/44 • Number of events 1 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Investigations
Cd4 Lymphocytes Decreased
|
11.4%
10/88 • Number of events 11 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
9.1%
4/44 • Number of events 5 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Investigations
Viral Load Increased
|
0.00%
0/88 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
2.3%
1/44 • Number of events 1 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
1.1%
1/88 • Number of events 1 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
0.00%
0/44 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
Other adverse events
| Measure |
CYD Dengue Vaccine
n=88 participants at risk
Participants were administered a single dose of SC injection of live, attenuated, tetravalent CYD dengue vaccine each on Day 0, 6 months and 12 months.
|
Placebo
n=44 participants at risk
Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.
|
|---|---|---|
|
General disorders
Asthenia
|
30.7%
27/88 • Number of events 38 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
36.4%
16/44 • Number of events 18 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
General disorders
Injection Site Pain
|
18.2%
16/88 • Number of events 22 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
29.5%
13/44 • Number of events 18 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
General disorders
Malaise
|
36.4%
32/88 • Number of events 47 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
47.7%
21/44 • Number of events 27 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Infections and infestations
Covid-19
|
6.8%
6/88 • Number of events 6 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
4.5%
2/44 • Number of events 2 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.5%
4/88 • Number of events 4 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
15.9%
7/44 • Number of events 7 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.7%
27/88 • Number of events 39 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
40.9%
18/44 • Number of events 22 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
|
Nervous system disorders
Headache
|
47.7%
42/88 • Number of events 67 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
63.6%
28/44 • Number of events 49 • From the date of randomization until 6-month safety follow-up (approximately 38 months)
Analysis was performed on SafAS population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The 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