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Trial record 63 of 97 for:    "Dengue Hemorrhagic Fever"

A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children

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ClinicalTrials.gov Identifier: NCT00384670
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : February 24, 2014
Last Update Posted : February 24, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Dengue Fever
Interventions Biological: Dengue Vaccine Formulation 17
Biological: Licensed Japanese Encephalitis (JE) Vaccine
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description 1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Dengue Vaccine and Japanese Encephalitis Vaccine
Hide Arm/Group Description 1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
7
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
6.6  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
5
  71.4%
Male
2
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 7 participants
7
1.Primary Outcome
Title Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine.
Hide Description Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description:
1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: adverse events
Abdominal Pain 1
Fatigue 3
Headache 5
Muscle and/or Joint Aches 3
Pain Behind Eyes 2
Photophobia 0
Pruritus 2
Elevated Temperature 4
Vomiting and/or Nausea 1
2.Secondary Outcome
Title Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine
Hide Description Number of subjects with unsolicited symptoms classified by MedDRA Primary System Organ Class and Preferred Term, within 30 days after dengue vaccine (total vaccinated cohort)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description:
1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: adverse events
At least one symptom 7
Infections and Infestations 2
Nervous System Disorders 1
Respiratory, Thoracic and Mediastinal Disorders 6
3.Secondary Outcome
Title Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine
Hide Description Number of solicited general symptoms within the 21-day follow-up of dengue dose 2 vaccine dose (total vaccinated cohort)
Time Frame 21 Days (0-20) After the Second Dose of Dengue Vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description:
1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: adverse events
Abdominal Pain 0
Fatigue 3
Headache 3
Muscle and/or Joint Aches 2
Pain Behind Eyes 1
Photophobia 1
Pruritus 2
Elevated Temperature 3
Vomiting and/or Nausea 1
4.Secondary Outcome
Title Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.
Hide Description Percentage of individuals with ≥ 10 dilution (DIL) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to Japanese encephalitis (JE) vaccine antibody titers.
Time Frame 30 days after the second dose of JE vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description:
1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Participants Analyzed 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
N Ig to DEN-1
100
(54.1 to 100)
N Ig to DEN-2
100
(54.1 to 100)
N Ig to DEN-3
100
(54.1 to 100)
N Ig to DEN-4
83.3
(35.9 to 99.6)
N Ig to JE
33.3
(4.3 to 77.7)
5.Secondary Outcome
Title Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.
Hide Description Geometric mean titers (GMT) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to JE vaccine antibody titers.
Time Frame Approximately Day 225 and Day 255
Hide Outcome Measure Data
Hide Analysis Population Description
1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description:
1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Participants Analyzed 6
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
N Ig to DEN-1
55.8
(15.3 to 203.1)
N Ig to DEN-2
107.4
(39.5 to 292.0)
N Ig to DEN-3
37.0
(8.7 to 158.2)
N Ig to DEN-4
36.9
(11.0 to 123.4)
N Ig to JE
8.7
(3.4 to 22.5)
6.Secondary Outcome
Title Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine.
Hide Description Number of solicited general symptoms within the 7-day follow-up after the first dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)
Time Frame Approximately Day 225 and Day 255
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description:
1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: adverse events
Abdominal Pain 1
Fatigue 1
Headache 2
Muscle and/or Joint Aches 1
Photophobia 1
Pruritus 1
Elevated Temperature 1
Vomiting and/or Nausea 1
7.Secondary Outcome
Title Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine.
Hide Description Number of solicited general symptoms within the 7-day follow-up after the second dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)
Time Frame Approximately Day 225 and Day 255
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dengue and Japanese Encephalitis Vaccine
Hide Arm/Group Description:
1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Number of solicited general symptoms
Abdominal Pain 0
Fatigue 0
Headache 1
Muscle and/or Joint Aches 0
Photophobia 0
Pruritus 1
Elevated Temperature 0
Vomiting and/or Nausea 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dengue Vaccine and Japanese Encephalitis Vaccine
Hide Arm/Group Description 1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
All-Cause Mortality
Dengue Vaccine and Japanese Encephalitis Vaccine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dengue Vaccine and Japanese Encephalitis Vaccine
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.4%
Dengue Vaccine and Japanese Encephalitis Vaccine
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Eye disorders   
Pain behind eyes   3/7 (42.86%)  3
Photophobia   1/7 (14.29%)  1
Gastrointestinal disorders   
Abdominal Pain   1/7 (14.29%)  1
Vomiting and/or Nausea   2/7 (28.57%)  2
General disorders   
Fatigue   4/7 (57.14%)  6
Elevated Temperature   5/7 (71.43%)  7
Infections and infestations   
Bronchitis *  1/7 (14.29%)  1
Meibomian cyst infected *  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Muscle and/or joint aches   3/7 (42.86%)  5
Nervous system disorders   
Headache   5/7 (71.43%)  8
Respiratory, thoracic and mediastinal disorders   
Nasal congestion *  2/7 (28.57%)  2
Rhinorrhoea *  4/7 (57.14%)  4
Skin and subcutaneous tissue disorders   
Pruritus   3/7 (42.86%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sriluck Simasathien ; Infectious Disease Consultant
Organization: Department of Pediatrics, Pharamongkutklao Hospital
Phone: 66-2-644-8971
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00384670     History of Changes
Other Study ID Numbers: WRAIR 1048
HSRRB#A-12189 ( Other Identifier: USAMRMC )
GSK Dengue-003 ( Other Identifier: GSK )
First Submitted: October 4, 2006
First Posted: October 6, 2006
Results First Submitted: May 23, 2012
Results First Posted: February 24, 2014
Last Update Posted: February 24, 2014