Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001 (NCT NCT00382408)
NCT ID: NCT00382408
Last Updated: 2017-04-10
Results Overview
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.
COMPLETED
PHASE3
4040 participants
Day 0 - Day 56
2017-04-10
Participant Flow
The study was conducted in subjects undergoing military basic training.
Participants were randomized to either the vaccine group or the matching placebo group in a 3:1 ratio.
Participant milestones
| Measure |
Vaccine
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Overall Study
STARTED
|
3031
|
1009
|
|
Overall Study
COMPLETED
|
2887
|
955
|
|
Overall Study
NOT COMPLETED
|
144
|
54
|
Reasons for withdrawal
| Measure |
Vaccine
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Overall Study
Did not meet protocol requirement
|
3
|
3
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
17
|
6
|
|
Overall Study
Pregnancy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
19
|
8
|
|
Overall Study
Other
|
100
|
35
|
Baseline Characteristics
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Baseline characteristics by cohort
| Measure |
Vaccine
n=3031 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=1009 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Total
n=4040 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
21.1 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
21.2 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Age, Customized
|
19.8 years
n=5 Participants
|
19.7 years
n=7 Participants
|
19.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1121 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
1488 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1910 Participants
n=5 Participants
|
642 Participants
n=7 Participants
|
2552 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
554 participants
n=5 Participants
|
186 participants
n=7 Participants
|
740 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
94 participants
n=5 Participants
|
29 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1871 participants
n=5 Participants
|
642 participants
n=7 Participants
|
2513 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
326 participants
n=5 Participants
|
103 participants
n=7 Participants
|
429 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
186 participants
n=5 Participants
|
49 participants
n=7 Participants
|
235 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3031 participants
n=5 Participants
|
1009 participants
n=7 Participants
|
4040 participants
n=5 Participants
|
|
Type-4 Titer
Negative
|
1906 participants
n=5 Participants
|
678 participants
n=7 Participants
|
2584 participants
n=5 Participants
|
|
Type-4 Titer
Positive
|
1123 participants
n=5 Participants
|
331 participants
n=7 Participants
|
1454 participants
n=5 Participants
|
|
Type-4 Titer
Unknown
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Type-7 Titer
Negative
|
1159 participants
n=5 Participants
|
377 participants
n=7 Participants
|
1536 participants
n=5 Participants
|
|
Type-7 Titer
Positive
|
1870 participants
n=5 Participants
|
632 participants
n=7 Participants
|
2502 participants
n=5 Participants
|
|
Type-7 Titer
Unknown
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 56Population: The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.
Outcome measures
| Measure |
Vaccine
n=3031 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=1009 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
|
1 participants
|
48 participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 56Population: The per-protocol (PP) cohort included all participants who met the eligibility criteria set forth in the protocol, did not have any significant violations or deviations from the protocol, and completed the final study visit (Day 56). Subjects who vomited within 24 hours after taking the study medication were excluded from the PP cohort.
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the per protocol cohort.
Outcome measures
| Measure |
Vaccine
n=2855 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=945 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort
|
1 participants
|
47 participants
|
PRIMARY outcome
Timeframe: Day 11 - Day 56Population: The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.
For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort; further, this outcome omitted ARD cases from Day 0-Day 10 because the protective effect of the vaccine was unlikely to take place during that time period.
Outcome measures
| Measure |
Vaccine
n=3031 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=1009 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56
|
0 participants
|
44 participants
|
PRIMARY outcome
Timeframe: Week 4Population: Type-7 ADV Seroconversion Cohort: Included those subjects who had a negative Type-7 ADV serum neutralizing antibody status at baseline (\<1:4) and at least one titer value for ADV-7 at the subsequent visits following vaccination.
ADV-7 seroconversion was defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-7 titer was \<1:4.
Outcome measures
| Measure |
Vaccine
n=1120 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=359 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Percentage of Participants Showing ADV-7 Seroconversion at Week 4
|
93.8 percentage of participants
Interval 92.4 to 95.2
|
5.3 percentage of participants
Interval 3.0 to 7.6
|
SECONDARY outcome
Timeframe: Week 4Population: Type-4 ADV Seroconversion Cohort: Included those subjects who had a negative Type-4 ADV serum neutralizing antibody status at baseline (\<1:4) and at least one titer value for ADV-4 at the subsequent visits following vaccination.
ADV-4 seroconversion was defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-4 titer was \<1:4.
Outcome measures
| Measure |
Vaccine
n=1841 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=653 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Percentage of Participants Showing ADV-4 Seroconversion at Week 4
|
94.5 percentage of participants
Interval 93.4 to 95.5
|
10.6 percentage of participants
Interval 8.2 to 12.9
|
SECONDARY outcome
Timeframe: Day 0 - Day 56Population: The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.
For the oral Type-4 vaccine, the number of cases of ADV-4 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.
Outcome measures
| Measure |
Vaccine
n=3031 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=1009 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
|
3 participants
|
65 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Type-4 ADV Booster Cohort included subjects who had a positive Type-4 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-4 at the subsequent visits following study medication administration.
ADV-4 booster effect is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-4 titer is ≥1:4.
Outcome measures
| Measure |
Vaccine
n=1094 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=326 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Percentage of Participants Showing ADV Type-4 Booster at Week 4
|
50.3 percentage of participants
Interval 47.3 to 53.2
|
0.6 percentage of participants
Interval -0.2 to 1.5
|
SECONDARY outcome
Timeframe: Day 0 - Day 56Population: The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.
For the oral Type-7 vaccine, a secondary outcome is the number of cases of ADV-7 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.
Outcome measures
| Measure |
Vaccine
n=3031 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=1009 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0 - Day 56Population: The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.
For the oral Type-7 vaccine, the number of cases of ADV-7 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.
Outcome measures
| Measure |
Vaccine
n=3031 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=1009 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Type-7 ADV Booster Cohort included subjects who had a positive Type-7 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-7 at the subsequent visits following study medication administration.
ADV-7 booster effect is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-7 titer is ≥1:4.
Outcome measures
| Measure |
Vaccine
n=1815 Participants
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Placebo
n=620 Participants
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Percentage of Participants Showing ADV Type-7 Booster at Week 4
|
46.1 percentage of participants
Interval 43.8 to 48.4
|
3.9 percentage of participants
Interval 2.4 to 5.4
|
Adverse Events
Placebo
Vaccine
Serious adverse events
| Measure |
Placebo
n=1009 participants at risk
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Vaccine
n=3031 participants at risk
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 2 • Day 0 (vaccination day) - Day 56
|
|
General disorders
HERNIA
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Immune system disorders
FOOD ALLERGY
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
APPENDICITIS
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
BRONCHITIS ACUTE
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
CELLULITIS
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.07%
2/3031 • Number of events 2 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.07%
2/3031 • Number of events 2 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
FOREARM FRACTURE
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.10%
3/3031 • Number of events 3 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
LIGAMENT INJURY
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.07%
2/3031 • Number of events 2 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
STRUCK BY LIGHTNING
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
ADJUSTMENT DISORDER
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.10%
3/3031 • Number of events 3 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
ADJUSTMENT DISORDER WITH ANXIETY
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
ADJUSTMENT DISORDER WITH DEPRESSED MOOD
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
CYCLOTHYMIC DISORDER
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
PERSONALITY DISORDER
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
STRESS
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.00%
0/3031 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.10%
1/1009 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.20%
2/1009 • Number of events 2 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/1009 • Day 0 (vaccination day) - Day 56
|
0.03%
1/3031 • Number of events 1 • Day 0 (vaccination day) - Day 56
|
Other adverse events
| Measure |
Placebo
n=1009 participants at risk
Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
Vaccine
n=3031 participants at risk
Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
17.3%
175/1009 • Number of events 216 • Day 0 (vaccination day) - Day 56
|
15.9%
482/3031 • Number of events 593 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.1%
112/1009 • Number of events 142 • Day 0 (vaccination day) - Day 56
|
12.8%
387/3031 • Number of events 484 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
NAUSEA
|
19.1%
193/1009 • Number of events 246 • Day 0 (vaccination day) - Day 56
|
18.2%
552/3031 • Number of events 654 • Day 0 (vaccination day) - Day 56
|
|
Gastrointestinal disorders
VOMITING
|
6.7%
68/1009 • Number of events 77 • Day 0 (vaccination day) - Day 56
|
6.0%
181/3031 • Number of events 209 • Day 0 (vaccination day) - Day 56
|
|
General disorders
CHILLS
|
5.5%
55/1009 • Number of events 56 • Day 0 (vaccination day) - Day 56
|
2.8%
84/3031 • Number of events 86 • Day 0 (vaccination day) - Day 56
|
|
General disorders
PYREXIA
|
5.9%
60/1009 • Number of events 60 • Day 0 (vaccination day) - Day 56
|
4.6%
139/3031 • Number of events 146 • Day 0 (vaccination day) - Day 56
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
42.0%
424/1009 • Number of events 490 • Day 0 (vaccination day) - Day 56
|
39.4%
1193/3031 • Number of events 1361 • Day 0 (vaccination day) - Day 56
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
13.0%
131/1009 • Number of events 134 • Day 0 (vaccination day) - Day 56
|
15.7%
475/3031 • Number of events 493 • Day 0 (vaccination day) - Day 56
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
26.8%
270/1009 • Number of events 372 • Day 0 (vaccination day) - Day 56
|
26.0%
787/3031 • Number of events 1070 • Day 0 (vaccination day) - Day 56
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.5%
55/1009 • Number of events 57 • Day 0 (vaccination day) - Day 56
|
3.6%
110/3031 • Number of events 113 • Day 0 (vaccination day) - Day 56
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.1%
72/1009 • Number of events 79 • Day 0 (vaccination day) - Day 56
|
7.7%
233/3031 • Number of events 254 • Day 0 (vaccination day) - Day 56
|
|
Nervous system disorders
HEADACHE
|
44.3%
447/1009 • Number of events 659 • Day 0 (vaccination day) - Day 56
|
40.8%
1237/3031 • Number of events 1795 • Day 0 (vaccination day) - Day 56
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
23.6%
238/1009 • Number of events 294 • Day 0 (vaccination day) - Day 56
|
22.6%
685/3031 • Number of events 855 • Day 0 (vaccination day) - Day 56
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
22.4%
226/1009 • Number of events 273 • Day 0 (vaccination day) - Day 56
|
24.4%
740/3031 • Number of events 927 • Day 0 (vaccination day) - Day 56
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
23.1%
233/1009 • Number of events 271 • Day 0 (vaccination day) - Day 56
|
24.5%
743/3031 • Number of events 912 • Day 0 (vaccination day) - Day 56
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.
- Publication restrictions are in place
Restriction type: OTHER