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Trial record 47 of 61 for:    Neomycin sulfate

A Phase II Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00350337
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborators:
GlaxoSmithKline
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Dengue
Interventions Biological: Pre-transfection F17
Biological: Post-transfection F17
Biological: Post-transfection F19
Other: Placebo
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 22 22 21 21
Completed 17 19 18 21
Not Completed 5 3 3 0
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 22 22 21 21 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 21 participants 21 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
21
 100.0%
21
 100.0%
86
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 21 participants 21 participants 86 participants
35.9  (7.75) 32.8  (6.93) 33  (8.6) 35.8  (6.7) 34.3  (7.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 21 participants 21 participants 86 participants
Female
6
  27.3%
11
  50.0%
8
  38.1%
10
  47.6%
35
  40.7%
Male
16
  72.7%
11
  50.0%
13
  61.9%
11
  52.4%
51
  59.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 21 participants 21 participants 86 participants
22 22 21 21 86
1.Primary Outcome
Title N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4
Hide Description GMTs for DEN neut. antibodies –unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1
Time Frame Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with titer within specified range
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

Overall Number of Participants Analyzed 16 16 15
Mean (95% Confidence Interval)
Unit of Measure: GMT value
DEN-1: PRE Number Analyzed 16 participants 16 participants 15 participants
2
(2 to 2)
2
(2 to 2)
2
(2 to 2)
DEN-1: PI(M1) Number Analyzed 16 participants 16 participants 15 participants
13
(3 to 53)
8
(4 to 17)
55
(11 to 281)
DEN-1: PII(M7) Number Analyzed 14 participants 15 participants 12 participants
195
(57 to 665)
46
(12 to 175)
98
(25 to 387)
DEN-1: PRE III Number Analyzed 16 participants 6 participants 7 participants
NA [1] 
(NA to NA)
10.2
(1.7 to 61.6)
30.3
(4.6 to 197)
DEN-1: PIII(M1) Number Analyzed 16 participants 6 participants 7 participants
NA [2] 
(NA to NA)
42.7
(8.4 to 217)
73.3
(19.1 to 280)
DEN-2: PRE Number Analyzed 16 participants 16 participants 15 participants
2
(2 to 2)
2
(2 to 2)
2
(1 to 2)
DEN-2: P1(M1) Number Analyzed 16 participants 16 participants 15 participants
141
(43 to 460)
49
(14 to 169)
168
(41 to 680)
DEN-2: PII(M7) Number Analyzed 16 participants 16 participants 15 participants
666
(376 to 1179)
125
(30 to 523)
226
(70 to 729)
DEN-2: PRE III Number Analyzed 16 participants 16 participants 15 participants
NA [1] 
(NA to NA)
30
(3.9 to 227)
31.5
(6.3 to 157)
DEN-2: PIII(M1) Number Analyzed 16 participants 16 participants 15 participants
NA [1] 
(NA to NA)
100
(13.3 to 749)
194.5
(56.1 to 674)
DEN-3: PRE Number Analyzed 16 participants 16 participants 15 participants
2
(2 to 2)
2
(2 to 2)
2
(2 to 2)
DEN-3: PI(M1) Number Analyzed 16 participants 16 participants 15 participants
13
(4 to 38)
9
(4 to 18)
16
(5 to 50)
DEN-3: PII(M7) Number Analyzed 16 participants 16 participants 15 participants
78
(21 to 286)
27
(8 to 98)
48
(13 to 177)
DEN-3: PRE III Number Analyzed 16 participants 16 participants 15 participants
NA [1] 
(NA to NA)
4.1
(1.0 to 16.9)
10.1
(2.5 to 40.9)
DEN-3: PIII(M1) Number Analyzed 16 participants 16 participants 15 participants
NA [1] 
(NA to NA)
28.2
(3.2 to 249.4)
19.7
(5.6 to 69.8)
DEN-4: PRE Number Analyzed 16 participants 16 participants 15 participants
2
(2 to 2)
2
(2 to 2)
2
(2 to 2)
DEN-4: PI(M1) Number Analyzed 16 participants 16 participants 15 participants
16
(4 to 74)
30
(6 to 150)
28
(6 to 128)
DEN-4: PII(M7) Number Analyzed 16 participants 16 participants 15 participants
271
(53 to 1378)
62
(14 to 284)
41
(10 to 176)
DEN-4: PRE III Number Analyzed 16 participants 16 participants 15 participants
NA [1] 
(NA to NA)
17.3
(0.6 to 491.9)
12.1
(1.0 to 1466.2)
DEN-4: PIII(M1) Number Analyzed 16 participants 16 participants 15 participants
NA [1] 
(NA to NA)
44.4
(3.7 to 539.2)
32.2
(4.5 to 232.2)
[1]
Data not collected for this time point
[2]
Data not collected at this time point
2.Primary Outcome
Title Percentage of Subjects With Seropositivity Rates for Dengue Serotypes 1, 2, 3 and 4
Hide Description Serpositivity rates for DEN neut. antibodies –unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1
Time Frame Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.

Overall Number of Participants Analyzed 16 16 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % participants with seropositivity rates
DEN-1: PRE
0.0
(0.0 to 20.6)
0.0
(0.0 to 20.6)
0.0
(0.0 to 21.8)
DEN-1: PI(M1)
43.8
(19.8 to 70.1)
37.5
(15.2 to 64.6)
66.7
(38.4 to 88.2)
DEN-1: PII(M7)
92.9
(66.1 to 99.8)
73.3
(44.9 to 92.2)
83.3
(51.6 to 97.9)
DEN-1: PRE III
NA [1] 
(NA to NA)
66.7
(22.3 to 95.7)
71.4
(29.0 to 96.3)
DEN-1: PIII(M1)
NA [1] 
(NA to NA)
83.3
(35.9 to 99.6)
100
(59.0 to 100)
DEN-2: PRE
0.0
(0.0 to 20.6)
0.0
(0.0 to 20.6)
0.0
(0.0 to 21.8)
DEN-2: PI(M1)
87.5
(61.7 to 98.4)
68.8
(41.3 to 89.0)
86.7
(59.5 to 98.3)
DEN-2: PII(M7)
100
(76.8 to 100)
80.0
(51.9 to 95.7)
100
(73.5 to 100)
DEN-2: PRE III
NA [1] 
(NA to NA)
66.7
(22.3 to 95.7)
57.1
(18.4 to 90.1)
DEN-2: PIII(M1)
NA [1] 
(NA to NA)
83.3
(35.9 to 99.6)
100
(59.0 to 100)
DEN-3: PRE
0.0
(0.0 to 20.6)
0.0
(0.0 to 20.6)
0.0
(0.0 to 21.8)
DEN-3: PI(M1)
50.0
(24.7 to 75.3)
50.0
(24.7 to 75.3)
60.0
(32.3 to 83.7)
DEN-3: PII(M7)
71.4
(41.9 to 91.6)
66.7
(38.4 to 88.2)
83.3
(51.6 to 97.9)
DEN-3: PRE III
NA [1] 
(NA to NA)
16.7
(0.4 to 64.1)
42.9
(9.9 to 81.6)
DEN-3: PIII(M1)
NA [1] 
(NA to NA)
83.3
(35.9 to 99.6)
57.1
(18.4 to 90.1)
DEN-4: PRE
0.0
(0.0 to 20.6)
0.0
(0.0 to 20.6)
0.0
(0.0 to 21.8)
DEN-4: PI(M1)
37.5
(15.2 to 64.6)
56.3
(29.9 to 80.2)
53.3
(26.6 to 78.7)
DEN-4: PII(M7)
78.6
(49.2 to 95.3)
73.3
(44.9 to 92.2)
66.7
(34.9 to 90.1)
DEN-4: PRE III
NA [1] 
(NA to NA)
33.3
(4.3 to 77.7)
42.9
(9.9 to 81.6)
DEN-4: PIII(M1)
NA [1] 
(NA to NA)
83.3
(35.9 to 99.6)
57.1
(18.4 to 90.1)
[1]
Data not collected for this time point
3.Primary Outcome
Title Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine
Hide Description Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded.
Time Frame 21 days following 1st vaccination dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: participants
Any Grade 3 symptoms 1 1 4 3
General Grade 3 symptoms 0 0 3 2
Local Grade 3 symptoms 1 1 1 2
4.Secondary Outcome
Title Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine;
Hide Description [Not Specified]
Time Frame within 21 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 16 19 18 20
Measure Type: Number
Unit of Measure: participants
Any Grade 3 symptoms 1 1 1 0
General Grade 3 symptoms 1 1 1 0
Local Grade 3 symptoms 0 0 0 0
5.Secondary Outcome
Title Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose
Hide Description Summary of Unsolicited Adverse Events within 31 days after each dose of study vaccine dose (Primary total vaccinated cohort)
Time Frame within 31 days of study vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: Number of AEs
Any symptoms classified by MedDRA 27 17 24 30
Any symptoms reported 27 17 24 31
Grade 3 symptoms classified by MedDRA 1 2 3 2
Grade 3 symptoms reported 1 2 3 2
Casually related symptoms classified by MedDRA 6 1 3 6
Casually related symptoms reported 6 1 3 7
Grade 3 and casually related symptoms reported 0 0 0 1
6.Secondary Outcome
Title Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period;
Hide Description MA type = H0
Time Frame up to 202 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: participants
0 2 1 1
7.Secondary Outcome
Title Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose
Hide Description

Abnormal findings at DEN physical examination were defined as:

rash, generalized rash, hemorrhages (skin, conjunctival or mucosal), conjunctival injection, hepatomegaly, splenomegaly or lymphadenopathy; generalized lymphadenopathy (palpable lymph nodes in 4 or more of the following locations: cervical, axillary, inguinal or other with right and left sides considered as separate locations) positive tourniquet test (WHO criterion of 20 or more petechiae per 2.5 cm square)Results were reported positive/negative using the WHO criterion.

Time Frame throughout the 202 day study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: participants
Rash 3 1 3 0
Generalized Rash 1 0 2 0
Skin Hemorrhage 0 0 0 1
Conj. Hemorrhage 0 0 0 1
Conj. Injection 2 2 1 2 1
Mucosal Hemorrhage 2 1 1 1
Lymphadenopathy 4 6 7 4
Generalized Lymphadenopathy 0 1 0 1
Hepatomegaly 2 3 6 4
Splemonegaly 0 1 1 2
8.Secondary Outcome
Title Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort)
Hide Description The case definition of confirmed dengue used in this protocol requires fever (equivalent to an oral temperature ≥38.0ºC/≥ 100.4ºF) for three or more successive days, at least two of the signs or symptoms consistent with “suspected dengue” occurring during the period of fever, at least one clinical laboratory abnormality, and DEN viremia detected by RTqPCR. Cases not meeting all criteria were not considered “confirmed dengue.” The percentage of subjects with suspected or confirmed dengue were tabulated by group after each vaccination.
Time Frame Days 0-30 post vaccination periods (total vaccinated cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of participants
Dose 1: Suspected Dengue
4.5
(0.1 to 22.8)
0
(0.0 to 15.4)
0
(0.0 to 16.1)
4.8
(0.1 to 23.8)
Dose 1: Confirmed Dengue
0
(0.0 to 15.4)
0
(0.0 to 15.4)
0
(0.0 to 16.1)
0
(0.0 to 16.1)
Dose 2: Suspected Dengue
0
(0.0 to 19.5)
0
(0.0 to 17.6)
0
(0.0 to 18.5)
0
(0.0 to 16.8)
Dose 2: Confirmed Dengue
0
(0.0 to 19.5)
0
(0.0 to 17.6)
0
(0.0 to 18.5)
0
(0.0 to 16.8)
9.Secondary Outcome
Title Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose
Hide Description

Sero-response defined as:

For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer

Time Frame throughout study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 16 20 18 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
S- (prior to vaccination) DEN-1 Month 1
43.8
(19.8 to 70.1)
35.3
(14.2 to 61.7)
66.7
(38.4 to 88.2)
0
(0.0 to 18.5)
S+(prior to vaccination) DEN-1 Month 1
75
(19.4 to 99.4)
0
(0.0 to 70.8)
0
(0.0 to 70.8)
0
(0.0 to 97.5)
S- (prior to vaccination) DEN-2 Month 1
87.5
(61.7 to 98.4)
70.6
(44.0 to 89.7)
86.7
(59.5 to 98.3)
0
(0.0 to 20.6)
S+ (prior to vaccination) DEN-2 Month 1
50
(6.8 to 93.2)
33.3
(0.8 to 90.6)
33.3
(0.8 to 90.6)
0
(0.0 to 70.8)
S- (prior to vaccination) DEN-3 Month 1
50.0
(24.7 to 75.3)
50.0
(24.7 to 75.3)
60.0
(32.3 to 83.7)
0
(0.0 to 18.5)
S+ (prior to vaccination) DEN-3 Month 1
75
(19.4 to 99.4)
0
(0.0 to 60.2)
33.3
(0.8 to 90.6)
0
(0.0 to 97.5)
S- (prior to vaccination) DEN-4 Month 1
37.5
(15.2 to 64.6)
52.9
(27.8 to 77.0)
53.3
(26.3 to 78.7)
11.1
(1.4 to 34.7)
S- (prior to vaccination) DEN-5 Month 1
75.0
(19.4 to 99.4)
33.3
(0.8 to 90.6)
33.3
(0.8 to 90.6)
0
(0.0 to 97.5)
10.Secondary Outcome
Title Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued)
Hide Description

Sero-response defined as:

For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer

Time Frame throughout study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 16 18 15 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
S- (prior to vaccination) DEN-1 Month 7
92.9
(66.1 to 99.8)
73.3
(44.9 to 92.2)
83.3
(51.6 to 97.9)
5.6
(0.1 to 27.3)
S+(prior to vaccination) DEN-1 Month 7
50.0
(1.3 to 98.7)
0
(0.0 to 70.8)
0
(0.0 to 70.8)
0
(0.0 to 97.5)
S- (prior to vaccination) DEN-2 Month 7
100
(76.8 to 100)
80.0
(51.9 to 95.7)
100
(73.5 to 100)
0
(0.0 to 20.6)
S+ (prior to vaccination) DEN-2 Month 7
0
(0.0 to 84.2)
33.3
(0.8 to 90.6)
33.3
(0.8 to 90.6)
0
(0.0 to 70.8)
S- (prior to vaccination) DEN-3 Month 7
71.4
(41.9 to 91.6)
66.7
(38.4 to 88.2)
83.3
(51.6 to 97.9)
5.6
(0.1 to 27.3)
S+ (prior to vaccination) DEN-3 Month 7
50.0
(1.3 to 98.7)
33.3
(0.8 to 90.6)
33.3
(0.8 to 90.6)
0
(0.0 to 97.5)
S- (prior to vaccination) DEN-4 Month 7
78.6
(49.2 to 95.3)
73.3
(44.9 to 92.2)
66.7
(34.9 to 90.1)
0
(0.0 to 18.5)
S- (prior to vaccination) DEN-5 Month 7
50.0
(1.3 to 98.7)
33.3
(0.8 to 90.6)
33.3
(0.8 to 90.6)
0
(0.0 to 97.5)
11.Secondary Outcome
Title Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose.
Hide Description

For vireimia:

Negative = GEQ/µl result is equal to zero Undetermined = GEQ/µL result is below LOD Positive = GEQ/µL result is >= LOD

Time Frame throughout study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description:

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

Overall Number of Participants Analyzed 22 22 21 21
Measure Type: Number
Unit of Measure: participants
DEN-1 Dose 1 - Positive 0 0 0 0
DEN-1 Dose 1 - Undetermined 2 1 2 1
DEN-1 Dose 1 - Negative 18 21 19 20
DEN-1 Dose 1 - Missing 2 0 0 0
DEN-1 Dose 2 - Positive 0 0 0 0
DEN-1 Dose 2 - Undetermined 1 2 2 1
DEN-1 Dose 2 - Negative 15 17 16 19
DEN-1 Dose 2 - Missing 6 3 3 1
DEN-1 Overall Subject - Positive 0 0 0 0
DEN-1 Overall Subject - Undetermined 3 3 3 2
DEN-1 Overall Subject - Negative 13 16 15 18
DEN-1 Overall Subject - Missing 6 3 3 1
DEN- 2 Dose 1 - Positive 0 0 0 0
DEN- 2 Dose 1 - Undetermined 1 1 0 0
DEN- 2 Dose 1 - Negative 18 20 19 19
DEN- 2 Dose 1 - Missing 3 1 2 2
DEN- 2 Dose 2 - Positive 0 0 0 0
DEN- 2 Dose 2 - Undetermined 0 1 1 0
DEN- 2 Dose 2 - Negative 15 17 15 18
DEN- 2 Dose 2 - Missing 7 4 5 3
DEN- 2 Overall Subject - Positive 0 0 0 0
DEN- 2 Overall Subject - Undetermined 0 2 1 0
DEN- 2 Overall Subject - Negative 15 16 15 18
DEN- 2 Overall Subject - Missing 7 4 5 3
DEN- 3 Dose 1 - Postive 0 0 0 0
DEN- 3 Dose 1 - Undetermine 0 0 0 0
DEN- 3 Dose 1 - Negative 20 22 21 21
DEN- 3 Dose 1 - Missing 2 0 0 0
DEN- 3 Dose 2 - Postive 0 0 0 0
DEN- 3 Dose 2 - Undetermine 0 0 0 0
DEN- 3 Dose 2 - Negative 16 19 18 20
DEN- 3 Dose 2 - Missing 6 3 3 1
DEN- 3 Overall Subject - Positive 0 0 0 0
DEN- 3 Overall Subject - Undetermined 0 0 0 0
DEN- 3 Overall Subject - Negative 16 19 18 20
DEN- 3 Overall Subject - Missing 6 3 3 1
DEN- 4 Dose 1 - Positive 2 1 0 0
DEN- 4 Dose 1 - Undetermined 1 1 1 0
DEN- 4 Dose 1 - Negative 17 20 20 21
DEN- 4 Dose 1 - Missing 2 0 0 0
DEN- 4 Dose 2 - Postive 3 0 0 0
DEN- 4 Dose 2 - Undetermined 0 0 0 0
DEN- 4 Dose 2 - Negative 13 19 18 20
DEN- 4 Dose 2 - Missing 6 3 3 1
DEN- 4 Overall Subject - Positive 5 1 0 0
DEN- 4 Overall Subject - Undetermined 1 1 1 0
DEN- 4 Overall Subject - Negative 11 111 17 20
DEN- 4 Overall Subject - Missing 5 3 3 1
Time Frame Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Hide Arm/Group Description

4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine

monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection

4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection.

Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines

A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

0.5 mL for placebo

All-Cause Mortality
Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/22 (0.00%)      0/21 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      2/22 (9.09%)      1/21 (4.76%)      1/21 (4.76%)    
Injury, poisoning and procedural complications         
Procedural hypertension * 2  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Hodgkin's disease * 2  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders         
axonal demyelinating polyneuropathy/bilateral upper and lower extremeties  1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Social circumstances         
Rule out cerebral bleed secondary to assualt trauma (physical assault)  2  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pre-transfection F17 Post-transfection F17 Post-transfection F19 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/22 (86.36%)      19/22 (86.36%)      16/21 (76.19%)      13/21 (61.90%)    
Blood and lymphatic system disorders         
Anemia * 1  1/22 (4.55%)  1 2/22 (9.09%)  2 0/21 (0.00%)  0 1/21 (4.76%)  1
Cardiac disorders         
Sinus tachycardia * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Ear and labyrinth disorders         
Ear pain * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Eye disorders         
Pain behind the eyes  1  4/22 (18.18%)  4 7/22 (31.82%)  7 5/21 (23.81%)  5 3/21 (14.29%)  3
Photophobia  1  4/22 (18.18%)  4 3/22 (13.64%)  3 5/21 (23.81%)  5 4/21 (19.05%)  4
Conjunctivitis * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/22 (0.00%)  0 5/22 (22.73%)  5 5/21 (23.81%)  5 4/21 (19.05%)  4
Nausea  1  6/22 (27.27%)  6 5/22 (22.73%)  5 4/21 (19.05%)  4 2/21 (9.52%)  2
Vomiting  1  2/22 (9.09%)  2 3/22 (13.64%)  3 0/21 (0.00%)  0 0/21 (0.00%)  0
Diarrhea * 1  2/22 (9.09%)  2 1/22 (4.55%)  1 0/21 (0.00%)  0 2/21 (9.52%)  2
Flatulence * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Gastritis * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Gastroesophageal reflux disease * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 1/21 (4.76%)  1 0/21 (0.00%)  0
Gingival pain * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Tooth ache * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
General disorders         
Pain  1  9/22 (40.91%)  9 3/22 (13.64%)  3 5/21 (23.81%)  5 5/21 (23.81%)  5
Fatigue  1  10/22 (45.45%)  10 9/22 (40.91%)  9 6/21 (28.57%)  6 7/21 (33.33%)  7
Fever >37.5ºC  1  5/22 (22.73%)  5 7/22 (31.82%)  7 3/21 (14.29%)  3 5/21 (23.81%)  5
Axillary pain * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Chills * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Fatigue * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Inflammation * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Injection site bruising * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Swelling * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Vessel puncture site hemorrage * 1  2/22 (9.09%)  2 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Immune system disorders         
Hypersensitivity * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Infections and infestations         
Bronchitis * 1  1/22 (4.55%)  14 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Fungal rash * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Nasopharyngitis * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 2/21 (9.52%)  2 0/21 (0.00%)  0
Pharyngitis * 1  2/22 (9.09%)  2 1/22 (4.55%)  1 0/21 (0.00%)  0 1/21 (4.76%)  1
Rhinitis * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Tonsillitis * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Upper respiratory tract infection * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications         
Redness  1  8/22 (36.36%)  8 3/22 (13.64%)  3 5/21 (23.81%)  5 5/21 (23.81%)  5
Swelling  1  7/22 (31.82%)  7 4/22 (18.18%)  4 5/21 (23.81%)  5 3/21 (14.29%)  3
Contusion * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Facial bones fracture * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Nerve injury * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Procedural pain * 1  1/22 (4.55%)  1 2/22 (9.09%)  2 3/21 (14.29%)  3 1/21 (4.76%)  1
Thermal burn * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders         
Gout * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/22 (27.27%)  6 4/22 (18.18%)  4 3/21 (14.29%)  3 3/21 (14.29%)  3
Muscle aches  1  6/22 (27.27%)  6 5/22 (22.73%)  5 4/21 (19.05%)  4 4/21 (19.05%)  4
Back pain * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Muscle spasms * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Musculoskeletal pain * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1 2/21 (9.52%)  2
Myalgia * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Pain in extremity * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders         
Headache  1  14/22 (63.64%)  14 11/22 (50.00%)  11 10/21 (47.62%)  10 9/21 (42.86%)  9
Dizziness * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 2/21 (9.52%)  2
Headache * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1 1/21 (4.76%)  1
Tremor * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Psychiatric disorders         
Affect lability * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 1/21 (4.76%)  1
Insomnia * 1  2/22 (9.09%)  2 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Reproductive system and breast disorders         
Dysmenorrhea * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 1/21 (4.76%)  1
Ejaculation failure * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 2/21 (9.52%)  2
Nasal congestion * 1  0/22 (0.00%)  0 2/22 (9.09%)  2 1/21 (4.76%)  1 1/21 (4.76%)  1
Pharyngolaryngeal pain * 1  1/22 (4.55%)  1 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Productive cough * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Sinus congestion * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1 1/21 (4.76%)  1
Wheezing * 1  0/22 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  9/22 (40.91%)  9 3/22 (13.64%)  3 3/21 (14.29%)  3 4/21 (19.05%)  4
Rash  1  7/22 (31.82%)  7 3/22 (13.64%)  3 3/21 (14.29%)  3 0/21 (0.00%)  0
Dermatitis * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
Dermatitis contact * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Erythema * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Pruritus * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Skin irritation * 1  1/22 (4.55%)  1 1/22 (4.55%)  1 0/21 (0.00%)  0 0/21 (0.00%)  0
Skin lesion * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Skin warm * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Social circumstances         
Physical assault * 1  0/22 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Surgical and medical procedures         
Phlebotomy * 1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Division of Regulated Activities and Compliance Director
Organization: United States Army Medical Materiel Development Activity
Phone: 301-619-0317
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00350337     History of Changes
Other Study ID Numbers: WRAIR 1151
GSK 103996 ( Other Identifier: GalaxoSmithKline )
HSRRB A-13291 ( Other Identifier: USAMRMC HSRRB )
First Submitted: July 6, 2006
First Posted: July 10, 2006
Results First Submitted: June 6, 2011
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018