Trial Outcomes & Findings for Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever (NCT NCT01224639)
NCT ID: NCT01224639
Last Updated: 2018-06-19
Results Overview
Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than \[\>\] 15 millimeter \[mm\]); Moderate as (15-30 mm); Severe (\>30 mm), swelling was categorized as Mild (\<15 mm); Moderate (15-30 mm); Severe (\>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
96 participants
Primary outcome timeframe
Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Results posted on
2018-06-19
Participant Flow
Participants took part in the study at 1 investigative site in Colombia from 11 October 2010 to 09 November 2011.
Healthy male and female participants were enrolled in 1 of the 8 treatment groups: Low Dose Subcutaneous:TDV, Low Dose Subcutaneous: Placebo, Low Dose Intradermal:TDV, Low Dose Intradermal:Placebo, High Dose Subcutaneous:TDV, High Dose Subcutaneous:Placebo, High Dose Intradermal:TDV, High Dose Intradermal:Placebo.
Participant milestones
| Measure |
Low Dose Subcutaneous: TDV
TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). Takeda's Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 plaque forming units (PFU), TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
5
|
21
|
3
|
21
|
4
|
18
|
5
|
|
Overall Study
COMPLETED
|
19
|
5
|
21
|
3
|
19
|
4
|
17
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Low Dose Subcutaneous: TDV
TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). Takeda's Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 plaque forming units (PFU), TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever
Baseline characteristics by cohort
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Less than (<) 18 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
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
|
Age, Customized
Greater than or equal to (>=) 18 and <65 years
|
19 participants
n=5 Participants
|
5 participants
n=7 Participants
|
21 participants
n=5 Participants
|
3 participants
n=4 Participants
|
21 participants
n=21 Participants
|
4 participants
n=8 Participants
|
18 participants
n=8 Participants
|
5 participants
n=24 Participants
|
96 participants
n=42 Participants
|
|
Age, Customized
>=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
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
67 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
7 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
3 participants
n=4 Participants
|
21 participants
n=21 Participants
|
4 participants
n=8 Participants
|
18 participants
n=8 Participants
|
4 participants
n=24 Participants
|
89 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than \[\>\] 15 millimeter \[mm\]); Moderate as (15-30 mm); Severe (\>30 mm), swelling was categorized as Mild (\<15 mm); Moderate (15-30 mm); Severe (\>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local Injection Site Reaction by Severity
Pain: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Redness: Mild
|
1 participants
|
0 participants
|
12 participants
|
0 participants
|
1 participants
|
1 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Redness: Moderate
|
1 participants
|
0 participants
|
8 participants
|
0 participants
|
5 participants
|
0 participants
|
9 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Redness: Severe
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
7 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Swelling: Mild
|
0 participants
|
0 participants
|
10 participants
|
0 participants
|
2 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Swelling: Moderate
|
2 participants
|
0 participants
|
4 participants
|
0 participants
|
2 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Swelling: Severe
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Itching: Mild
|
4 participants
|
0 participants
|
12 participants
|
1 participants
|
7 participants
|
1 participants
|
13 participants
|
1 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Itching: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Local Injection Site Reaction by Severity
Pain: Mild
|
12 participants
|
1 participants
|
8 participants
|
2 participants
|
8 participants
|
0 participants
|
10 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (\>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Eye pain: Mild
|
6 participants
|
2 participants
|
8 participants
|
1 participants
|
4 participants
|
1 participants
|
7 participants
|
1 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Fever: Mild
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Fever: Moderate
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Fever: Severe
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Headache: Mild
|
4 participants
|
1 participants
|
12 participants
|
2 participants
|
9 participants
|
0 participants
|
6 participants
|
2 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Headache: Moderate
|
7 participants
|
1 participants
|
4 participants
|
0 participants
|
2 participants
|
1 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Headache: Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Muscle pain: Mild
|
10 participants
|
0 participants
|
3 participants
|
2 participants
|
4 participants
|
0 participants
|
6 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Muscle pain: Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Muscle pain: Severe
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Joint pain: Mild
|
4 participants
|
0 participants
|
2 participants
|
0 participants
|
3 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Joint pain: Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Joint pain: Severe
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Eye pain: Moderate
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Eye pain: Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Photophobia: Mild
|
5 participants
|
1 participants
|
6 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Photophobia: Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Photophobia: Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Fatigue: Mild
|
9 participants
|
2 participants
|
7 participants
|
1 participants
|
5 participants
|
0 participants
|
10 participants
|
4 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Fatigue: Moderate
|
3 participants
|
0 participants
|
4 participants
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Fatigue: Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Body Rash: Mild
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Body Rash: Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Body Rash: Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Nausea: Mild
|
4 participants
|
2 participants
|
4 participants
|
1 participants
|
4 participants
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Nausea: Moderate
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Nausea: Severe
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Vomiting: Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Vomiting: Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Vomiting: Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Other: Mild
|
4 participants
|
0 participants
|
2 participants
|
0 participants
|
6 participants
|
1 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Other: Moderate
|
2 participants
|
1 participants
|
4 participants
|
0 participants
|
4 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Systemic Adverse Events (AEs) by Severity
Other: Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic AEs
Local solicited AEs
|
15 participants
|
1 participants
|
20 participants
|
2 participants
|
14 participants
|
1 participants
|
18 participants
|
1 participants
|
|
Number of Participants With Solicited Local and Systemic AEs
Systemic solicited AEs
|
17 participants
|
4 participants
|
17 participants
|
2 participants
|
17 participants
|
3 participants
|
17 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after second vaccination (Day 120)Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Local and Systemic AEs
Systemic unsolicited AEs
|
18 participants
|
5 participants
|
16 participants
|
3 participants
|
16 participants
|
2 participants
|
14 participants
|
3 participants
|
|
Number of Participants With Unsolicited Local and Systemic AEs
Local unsolicited AEs
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 14, 30, 60 and 90 after first vaccinationPopulation: The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing microneutralization (MN) Assay samples.
GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
7.75 titer
Interval 5.02 to 11.96
|
5.00 titer
Interval 5.0 to 5.0
|
11.04 titer
Interval 6.26 to 19.46
|
5.00 titer
Interval 5.0 to 5.0
|
5.71 titer
Interval 4.72 to 6.9
|
5.00 titer
Interval 5.0 to 5.0
|
11.22 titer
Interval 5.4 to 23.32
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
25.82 titer
Interval 9.77 to 68.26
|
5.00 titer
Interval 5.0 to 5.0
|
67.83 titer
Interval 25.66 to 179.29
|
5.00 titer
Interval 5.0 to 5.0
|
42.03 titer
Interval 22.35 to 79.05
|
5.00 titer
Interval 5.0 to 5.0
|
307.91 titer
Interval 115.76 to 819.04
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
33.33 titer
Interval 14.01 to 79.31
|
5.00 titer
Interval 5.0 to 5.0
|
57.51 titer
Interval 21.68 to 152.57
|
5.00 titer
Interval 5.0 to 5.0
|
9.06 titer
Interval 4.89 to 16.79
|
5.00 titer
Interval 5.0 to 5.0
|
22.88 titer
Interval 10.76 to 48.69
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
12.45 titer
Interval 8.32 to 18.61
|
5.00 titer
Interval 5.0 to 5.0
|
22.08 titer
Interval 12.64 to 38.58
|
5.00 titer
Interval 5.0 to 5.0
|
111.29 titer
Interval 58.46 to 211.83
|
5.00 titer
Interval 5.0 to 5.0
|
72.66 titer
Interval 27.52 to 191.86
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
6.94 titer
Interval 4.31 to 11.19
|
5.00 titer
Interval 5.0 to 5.0
|
7.43 titer
Interval 4.89 to 11.29
|
5.00 titer
Interval 5.0 to 5.0
|
6.73 titer
Interval 4.72 to 9.59
|
5.00 titer
Interval 5.0 to 5.0
|
7.64 titer
Interval 3.39 to 17.2
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
17.93 titer
Interval 8.2 to 39.17
|
5.00 titer
Interval 5.0 to 5.0
|
20.00 titer
Interval 9.17 to 43.6
|
5.00 titer
Interval 5.0 to 5.0
|
26.04 titer
Interval 12.3 to 55.13
|
5.00 titer
Interval 5.0 to 5.0
|
117.58 titer
Interval 41.32 to 334.54
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
230.44 titer
Interval 66.23 to 801.82
|
5.00 titer
Interval 5.0 to 5.0
|
262.51 titer
Interval 63.99 to 1076.87
|
5.00 titer
Interval 5.0 to 5.0
|
1280.00 titer
Interval 768.38 to 2132.27
|
5.00 titer
Interval 5.0 to 5.0
|
838.01 titer
Interval 375.38 to 1870.77
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5)
|
49.79 titer
Interval 26.0 to 95.36
|
5.00 titer
Interval 5.0 to 5.0
|
48.76 titer
Interval 27.94 to 85.09
|
5.00 titer
Interval 5.0 to 5.0
|
208.37 titer
Interval 102.74 to 422.61
|
5.00 titer
Interval 5.0 to 5.0
|
153.96 titer
Interval 80.16 to 295.69
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
363.60 titer
Interval 73.44 to 1800.07
|
5.00 titer
Interval 5.0 to 5.0
|
475.52 titer
Interval 88.35 to 2559.42
|
5.00 titer
Interval 5.0 to 5.0
|
8682.13 titer
Interval 5174.46 to 14567.58
|
5.00 titer
Interval 5.0 to 5.0
|
2370.24 titer
Interval 718.63 to 7817.74
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
34.57 titer
Interval 14.13 to 84.59
|
5.00 titer
Interval 5.0 to 5.0
|
50.40 titer
Interval 20.72 to 122.56
|
5.00 titer
Interval 5.0 to 5.0
|
30.99 titer
Interval 18.33 to 52.37
|
5.00 titer
Interval 5.0 to 5.0
|
148.14 titer
Interval 50.82 to 431.83
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
13.39 titer
Interval 7.04 to 25.46
|
5.00 titer
Interval 5.0 to 5.0
|
26.48 titer
Interval 10.42 to 67.3
|
5.00 titer
Interval 5.0 to 5.0
|
5.58 titer
Interval 4.43 to 7.02
|
5.00 titer
Interval 5.0 to 5.0
|
10.60 titer
Interval 5.31 to 21.13
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
34.57 titer
Interval 16.17 to 73.92
|
5.00 titer
Interval 5.0 to 5.0
|
43.44 titer
Interval 18.91 to 99.8
|
5.00 titer
Interval 5.0 to 5.0
|
109.09 titer
Interval 49.55 to 240.18
|
5.00 titer
Interval 5.0 to 5.0
|
80.00 titer
Interval 33.72 to 189.78
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
181.80 titer
Interval 55.42 to 596.4
|
5.00 titer
Interval 5.0 to 5.0
|
309.61 titer
Interval 94.5 to 1014.43
|
5.00 titer
Interval 5.0 to 5.0
|
1912.01 titer
Interval 1254.58 to 2913.94
|
5.00 titer
Interval 5.0 to 5.0
|
666.63 titer
Interval 305.13 to 1456.45
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
49.79 titer
Interval 23.98 to 103.39
|
5.00 titer
Interval 5.0 to 5.0
|
38.70 titer
Interval 19.18 to 78.08
|
6.30 titer
Interval 2.33 to 17.02
|
103.28 titer
Interval 50.97 to 209.26
|
5.00 titer
Interval 5.0 to 5.0
|
86.40 titer
Interval 39.48 to 189.1
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
30.99 titer
Interval 13.75 to 69.81
|
5.00 titer
Interval 5.0 to 5.0
|
60.43 titer
Interval 27.22 to 134.18
|
5.00 titer
Interval 5.0 to 5.0
|
34.57 titer
Interval 20.61 to 57.99
|
5.00 titer
Interval 5.0 to 5.0
|
135.92 titer
Interval 51.41 to 359.33
|
5.00 titer
Interval 5.0 to 5.0
|
|
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
11.16 titer
Interval 6.11 to 20.38
|
5.00 titer
Interval 5.0 to 5.0
|
28.29 titer
Interval 11.62 to 68.86
|
5.00 titer
Interval 5.0 to 5.0
|
6.22 titer
Interval 5.12 to 7.56
|
5.00 titer
Interval 5.0 to 5.0
|
11.30 titer
Interval 5.86 to 21.81
|
5.00 titer
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Days 14 and 30 after second vaccination (Day 104 and 120 respectively)Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing MN Assay samples.
GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
111.09 titer
Interval 45.46 to 271.46
|
5.00 titer
Interval 5.0 to 5.0
|
137.92 titer
Interval 68.77 to 276.6
|
5.00 titer
Interval 5.0 to 5.0
|
244.39 titer
Interval 133.53 to 447.3
|
5.00 titer
Interval 5.0 to 5.0
|
230.93 titer
Interval 131.23 to 406.38
|
5.00 titer
Interval 5.0 to 5.0
|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
222.18 titer
Interval 76.63 to 644.18
|
5.00 titer
Interval 5.0 to 5.0
|
341.84 titer
Interval 102.43 to 1140.85
|
5.00 titer
Interval 5.0 to 5.0
|
1382.48 titer
Interval 935.89 to 2042.17
|
5.00 titer
Interval 5.0 to 5.0
|
589.88 titer
Interval 277.32 to 1254.75
|
5.00 titer
Interval 5.0 to 5.0
|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
73.03 titer
Interval 33.64 to 158.56
|
5.00 titer
Interval 5.0 to 5.0
|
144.92 titer
Interval 81.49 to 257.7
|
5.00 titer
Interval 5.0 to 5.0
|
63.50 titer
Interval 45.45 to 88.71
|
5.00 titer
Interval 5.0 to 5.0
|
250.56 titer
Interval 127.21 to 493.5
|
5.00 titer
Interval 5.0 to 5.0
|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
21.51 titer
Interval 11.58 to 39.95
|
5.00 titer
Interval 5.0 to 5.0
|
72.46 titer
Interval 35.46 to 148.05
|
5.00 titer
Interval 5.0 to 5.0
|
10.39 titer
Interval 7.09 to 15.24
|
5.00 titer
Interval 5.0 to 5.0
|
27.71 titer
Interval 14.56 to 52.77
|
5.00 titer
Interval 5.0 to 5.0
|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3)
|
128.55 titer
Interval 52.36 to 315.6
|
5.00 titer
Interval 5.0 to 5.0
|
92.81 titer
Interval 47.92 to 179.77
|
5.00 titer
Interval 5.0 to 5.0
|
181.82 titer
Interval 101.33 to 326.24
|
5.00 titer
Interval 5.0 to 5.0
|
160.00 titer
Interval 91.07 to 281.09
|
5.00 titer
Interval 5.0 to 5.0
|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
206.55 titer
Interval 64.16 to 664.9
|
5.00 titer
Interval 5.0 to 5.0
|
314.76 titer
Interval 95.01 to 1042.74
|
5.00 titer
Interval 5.0 to 5.0
|
1536.13 titer
Interval 972.63 to 2426.11
|
5.00 titer
Interval 5.0 to 5.0
|
543.69 titer
Interval 248.7 to 1188.55
|
5.00 titer
Interval 5.0 to 5.0
|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
69.14 titer
Interval 33.72 to 141.77
|
5.00 titer
Interval 5.0 to 5.0
|
88.33 titer
Interval 46.17 to 168.99
|
5.00 titer
Interval 5.0 to 5.0
|
78.56 titer
Interval 49.89 to 123.7
|
5.00 titer
Interval 5.0 to 5.0
|
271.84 titer
Interval 126.94 to 582.17
|
5.00 titer
Interval 5.0 to 5.0
|
|
GMTs of All Four Dengue Serotypes After Second Vaccination
Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
20.74 titer
Interval 10.59 to 40.64
|
5.00 titer
Interval 5.0 to 5.0
|
48.76 titer
Interval 24.58 to 96.74
|
5.00 titer
Interval 5.0 to 5.0
|
9.64 titer
Interval 6.41 to 14.51
|
5.00 titer
Interval 5.0 to 5.0
|
16.99 titer
Interval 9.34 to 30.9
|
5.00 titer
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Days 14, 30, 60 and 90 after first vaccinationPopulation: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT\[50\]) \>=10 (if the pre-vaccination PRNT\[50\] value was \<10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was \>=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT\[50\] value was \>=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
52.6 percentage of participants
Interval 28.9 to 75.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
42.9 percentage of participants
Interval 21.8 to 66.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
52.4 percentage of participants
Interval 29.8 to 74.3
|
0 percentage of participants
Interval 0.0 to 60.2
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
21.1 percentage of participants
Interval 6.1 to 45.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
0 percentage of participants
Interval 0.0 to 60.2
|
38.9 percentage of participants
Interval 17.2 to 64.3
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
89.5 percentage of participants
Interval 66.9 to 98.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
0 percentage of participants
Interval 0.0 to 60.2
|
100 percentage of participants
Interval 81.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
63.2 percentage of participants
Interval 38.4 to 83.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
66.7 percentage of participants
Interval 43.0 to 85.4
|
0 percentage of participants
Interval 0.0 to 70.8
|
89.5 percentage of participants
Interval 66.9 to 98.7
|
0 percentage of participants
Interval 0.0 to 60.2
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
63.2 percentage of participants
Interval 38.4 to 83.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
66.7 percentage of participants
Interval 43.0 to 85.4
|
0 percentage of participants
Interval 0.0 to 70.8
|
90.5 percentage of participants
Interval 69.8 to 98.8
|
0 percentage of participants
Interval 0.0 to 60.2
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
10.5 percentage of participants
Interval 1.3 to 33.1
|
0 percentage of participants
Interval 0.0 to 52.2
|
19.0 percentage of participants
Interval 5.4 to 41.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
0 percentage of participants
Interval 0.0 to 60.2
|
11.1 percentage of participants
Interval 1.4 to 34.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
89.5 percentage of participants
Interval 66.9 to 98.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
90.5 percentage of participants
Interval 69.6 to 98.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
95.2 percentage of participants
Interval 76.2 to 99.9
|
0 percentage of participants
Interval 0.0 to 60.2
|
100 percentage of participants
Interval 81.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
66.7 percentage of participants
Interval 43.0 to 85.4
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
57.9 percentage of participants
Interval 33.5 to 79.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
0 percentage of participants
Interval 0.0 to 70.8
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
0 percentage of participants
Interval 0.0 to 60.2
|
94.4 percentage of participants
Interval 72.7 to 99.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5)
|
63.2 percentage of participants
Interval 38.4 to 83.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
0 percentage of participants
Interval 0.0 to 70.8
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
0 percentage of participants
Interval 0.0 to 60.2
|
66.7 percentage of participants
Interval 41.0 to 86.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
78.9 percentage of participants
Interval 54.4 to 93.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
66.7 percentage of participants
Interval 43.0 to 85.4
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
94.4 percentage of participants
Interval 72.7 to 99.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5)
|
47.4 percentage of participants
Interval 24.4 to 71.1
|
0 percentage of participants
Interval 0.0 to 52.2
|
42.9 percentage of participants
Interval 21.8 to 66.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
5.3 percentage of participants
Interval 0.1 to 26.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
33.3 percentage of participants
Interval 13.3 to 59.0
|
0 percentage of participants
Interval 0.0 to 52.2
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
0 percentage of participants
Interval 0.0 to 70.8
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
0 percentage of participants
Interval 0.0 to 60.2
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
36.8 percentage of participants
Interval 16.3 to 61.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
52.4 percentage of participants
Interval 29.8 to 74.3
|
0 percentage of participants
Interval 0.0 to 70.8
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
0 percentage of participants
Interval 0.0 to 60.2
|
41.2 percentage of participants
Interval 18.4 to 67.1
|
0 percentage of participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: Days 14 and 30 after second vaccination (Days 104 and 120 respectively)Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT\[50\]) \>=10 (if the pre-vaccination PRNT\[50\] value was \<10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was \>=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT\[50\] value was \>=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n).
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
78.9 percentage of participants
Interval 54.4 to 93.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 81.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 81.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
95.2 percentage of participants
Interval 76.2 to 99.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
90.5 percentage of participants
Interval 69.6 to 98.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
55.6 percentage of participants
Interval 30.8 to 78.5
|
0 percentage of participants
Interval 0.0 to 60.2
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3)
|
89.5 percentage of participants
Interval 66.9 to 98.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 81.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
78.9 percentage of participants
Interval 54.4 to 93.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 81.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3)
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
95.2 percentage of participants
Interval 76.2 to 99.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
47.4 percentage of participants
Interval 24.4 to 71.1
|
0 percentage of participants
Interval 0.0 to 60.2
|
76.5 percentage of participants
Interval 50.1 to 93.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: Days 180 and 270Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer \>=10 where pre-vaccination PRNT 50 titer \<10, or post-vaccination PRNT(50) Titer \>=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer \>=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=17 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Durability of Immune Response
Day 180 TDV-1
|
78.9 percentage of participants
Interval 54.4 to 93.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
90.5 percentage of participants
Interval 69.6 to 98.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With Durability of Immune Response
Day 270 TDV-2
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With Durability of Immune Response
Day 270 TDV-3
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
57.9 percentage of participants
Interval 33.5 to 79.7
|
0 percentage of participants
Interval 0.0 to 60.2
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With Durability of Immune Response
Day 180 TDV-2
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
0 percentage of participants
Interval 0.0 to 52.2
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 60.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With Durability of Immune Response
Day 180 TDV-3
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
94.7 percentage of participants
Interval 74.0 to 99.9
|
0 percentage of participants
Interval 0.0 to 60.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With Durability of Immune Response
Day 180 TDV-4
|
63.2 percentage of participants
Interval 38.4 to 83.7
|
0 percentage of participants
Interval 0.0 to 52.2
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
0 percentage of participants
Interval 0.0 to 70.8
|
31.6 percentage of participants
Interval 12.6 to 56.6
|
0 percentage of participants
Interval 0.0 to 60.2
|
52.9 percentage of participants
Interval 27.8 to 77.0
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With Durability of Immune Response
Day 270 TDV-1
|
68.4 percentage of participants
Interval 43.4 to 87.4
|
0 percentage of participants
Interval 0.0 to 52.2
|
66.7 percentage of participants
Interval 43.0 to 85.4
|
0 percentage of participants
Interval 0.0 to 70.8
|
89.5 percentage of participants
Interval 66.9 to 98.7
|
0 percentage of participants
Interval 0.0 to 60.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With Durability of Immune Response
Day 270 TDV-4
|
42.1 percentage of participants
Interval 20.3 to 66.5
|
0 percentage of participants
Interval 0.0 to 52.2
|
57.1 percentage of participants
Interval 34.0 to 78.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
15.8 percentage of participants
Interval 3.4 to 39.6
|
0 percentage of participants
Interval 0.0 to 60.2
|
35.3 percentage of participants
Interval 14.2 to 61.7
|
0 percentage of participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: Baseline and at multiple time points up to Day 14 after each vaccinationPopulation: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported.
Outcome measures
| Measure |
Low Dose Subcutaneous: TDV
n=19 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 Participants
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 Participants
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 Participants
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 Participants
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
4 participants
|
0 participants
|
7 participants
|
0 participants
|
17 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
6 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
5 participants
|
0 participants
|
6 participants
|
0 participants
|
9 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
3 participants
|
0 participants
|
3 participants
|
0 participants
|
10 participants
|
0 participants
|
8 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 14 Days after each vaccinationPopulation: Due to the low prevalence of vaccine viremia, estimates of average titer duration of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 Days after each vaccinationPopulation: Due to the low prevalence of vaccine viremia, estimates of average titer levels of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.
Outcome measures
Outcome data not reported
Adverse Events
Low Dose Subcutaneous: TDV
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Low Dose Subcutaneous: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Low Dose Intradermal: TDV
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Low Dose Intradermal: Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
High Dose Subcutaneous: TDV
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
High Dose Subcutaneous: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Dose Intradermal: TDV
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
High Dose Intradermal: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Subcutaneous: TDV
n=19 participants at risk
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 participants at risk
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 participants at risk
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 participants at risk
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 participants at risk
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 participants at risk
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 participants at risk
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 participants at risk
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
33.3%
1/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
Other adverse events
| Measure |
Low Dose Subcutaneous: TDV
n=19 participants at risk
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Subcutaneous: Placebo
n=5 participants at risk
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
Low Dose Intradermal: TDV
n=21 participants at risk
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU.
|
Low Dose Intradermal: Placebo
n=3 participants at risk
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Subcutaneous: TDV
n=21 participants at risk
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Subcutaneous: Placebo
n=4 participants at risk
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
|
High Dose Intradermal: TDV
n=18 participants at risk
TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU.
|
High Dose Intradermal: Placebo
n=5 participants at risk
TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
15.8%
3/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
25.0%
1/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
25.0%
1/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Gastrointestinal disorders
NAUSEA
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
General disorders
CHEST PAIN
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
General disorders
FATIGUE
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
33.3%
1/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
General disorders
INJECTION SITE HAEMATOMA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
General disorders
PYERXIA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
33.3%
1/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
General disorders
VACCINATION SITE HAEMATOMA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
14.3%
3/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
11.1%
2/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
General disorders
VACCINATION SITE SCAB
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
ASYMPTOMATIC BACTERIURIA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
33.3%
1/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
25.0%
1/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
NASOPHARYNGITIS
|
15.8%
3/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
40.0%
2/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
19.0%
4/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
23.8%
5/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
22.2%
4/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
ORAL HERPES
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
33.3%
1/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
10.5%
2/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Infections and infestations
VAGINITIS BACTERIAL
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
33.3%
1/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Investigations
BLOOD FIBRINOGEN INCREASED
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Nervous system disorders
DIZZINESS
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Nervous system disorders
HEADACHE
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
19.0%
4/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
33.3%
1/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
28.6%
6/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
25.0%
1/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
22.2%
4/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
4.8%
1/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
10.5%
2/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
25.0%
1/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.3%
1/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
14.3%
3/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
5.6%
1/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
9.5%
2/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
20.0%
1/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.00%
0/19 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/3 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/21 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
25.0%
1/4 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/18 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
|
0.00%
0/5 • Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120
A SAE is any untoward medical occurrence that at any dose was fatal, life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in persistent/significant disability/incapacity, congenital anomaly/birth defect, medically significant or required intervention to prevent one or other of the outcomes listed here.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER