Trial Outcomes & Findings for A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children (NCT NCT00384670)

NCT ID: NCT00384670

Last Updated: 2014-02-24

Results Overview

Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2014-02-24

Participant Flow

Participant milestones

Measure	Dengue and Japanese Encephalitis Vaccine 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 Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dengue Vaccine and Japanese Encephalitis Vaccine n=7 Participants 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.
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6.6 years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Thailand	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).

Outcome measures

Measure	Dengue and Japanese Encephalitis Vaccine n=7 Participants 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.
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Abdominal Pain	1 adverse events Interval 0.4 to 57.9
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Fatigue	3 adverse events Interval 9.9 to 81.6
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Headache	5 adverse events Interval 29.0 to 96.3
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Muscle and/or Joint Aches	3 adverse events Interval 9.9 to 81.6
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Pain Behind Eyes	2 adverse events Interval 28.6 to 3.7
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Photophobia	0 adverse events Interval 0.0 to 41.0
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Pruritus	2 adverse events Interval 3.7 to 71.0
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Elevated Temperature	4 adverse events Interval 18.4 to 90.1
Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine. Vomiting and/or Nausea	1 adverse events Interval 0.4 to 57.9

SECONDARY outcome

Timeframe: 30 days

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)

Outcome measures

Measure	Dengue and Japanese Encephalitis Vaccine n=7 Participants 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.
Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine At least one symptom	7 adverse events Interval 59.0 to 100.0
Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine Infections and Infestations	2 adverse events
Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine Nervous System Disorders	1 adverse events
Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine Respiratory, Thoracic and Mediastinal Disorders	6 adverse events

SECONDARY outcome

Timeframe: 21 Days (0-20) After the Second Dose of Dengue Vaccine

Number of solicited general symptoms within the 21-day follow-up of dengue dose 2 vaccine dose (total vaccinated cohort)

Outcome measures

Measure	Dengue and Japanese Encephalitis Vaccine n=7 Participants 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.
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Abdominal Pain	0 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Fatigue	3 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Headache	3 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Muscle and/or Joint Aches	2 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Pain Behind Eyes	1 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Photophobia	1 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Pruritus	2 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Elevated Temperature	3 adverse events
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine Vomiting and/or Nausea	1 adverse events

SECONDARY outcome

Timeframe: 30 days after the second dose of JE vaccine

Population: 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.

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.

Outcome measures

Measure	Dengue and Japanese Encephalitis Vaccine n=6 Participants 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.
Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-1	100 percentage of participants Interval 54.1 to 100.0
Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-2	100 percentage of participants Interval 54.1 to 100.0
Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-3	100 percentage of participants Interval 54.1 to 100.0
Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-4	83.3 percentage of participants Interval 35.9 to 99.6
Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to JE	33.3 percentage of participants Interval 4.3 to 77.7

SECONDARY outcome

Timeframe: Approximately Day 225 and Day 255

Population: 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.

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.

Outcome measures

Measure	Dengue and Japanese Encephalitis Vaccine n=6 Participants 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.
Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-1	55.8 titer Interval 15.3 to 203.1
Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-2	107.4 titer Interval 39.5 to 292.0
Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-3	37.0 titer Interval 8.7 to 158.2
Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to DEN-4	36.9 titer Interval 11.0 to 123.4
Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine. N Ig to JE	8.7 titer Interval 3.4 to 22.5

SECONDARY outcome

Timeframe: Approximately Day 225 and Day 255

Number of solicited general symptoms within the 7-day follow-up after the first dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)

Outcome measures

Measure	Dengue and Japanese Encephalitis Vaccine n=7 Participants 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.
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Abdominal Pain	1 adverse events
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Fatigue	1 adverse events
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Headache	2 adverse events
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Muscle and/or Joint Aches	1 adverse events
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Photophobia	1 adverse events
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Pruritus	1 adverse events
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Elevated Temperature	1 adverse events
Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine. Vomiting and/or Nausea	1 adverse events

SECONDARY outcome

Timeframe: Approximately Day 225 and Day 255

Number of solicited general symptoms within the 7-day follow-up after the second dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)

Outcome measures

Measure	Dengue and Japanese Encephalitis Vaccine n=7 Participants 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.
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Fatigue	0 Number of solicited general symptoms
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Headache	1 Number of solicited general symptoms
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Muscle and/or Joint Aches	0 Number of solicited general symptoms
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Abdominal Pain	0 Number of solicited general symptoms
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Photophobia	0 Number of solicited general symptoms
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Pruritus	1 Number of solicited general symptoms
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Elevated Temperature	0 Number of solicited general symptoms
Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine. Vomiting and/or Nausea	0 Number of solicited general symptoms

Adverse Events

Dengue Vaccine and Japanese Encephalitis Vaccine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dengue Vaccine and Japanese Encephalitis Vaccine n=7 participants at risk 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.
Gastrointestinal disorders Abdominal Pain	14.3% 1/7 • Number of events 1
General disorders Fatigue	57.1% 4/7 • Number of events 6
Nervous system disorders Headache	71.4% 5/7 • Number of events 8
Musculoskeletal and connective tissue disorders Muscle and/or joint aches	42.9% 3/7 • Number of events 5
Eye disorders Pain behind eyes	42.9% 3/7 • Number of events 3
Eye disorders Photophobia	14.3% 1/7 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus	42.9% 3/7 • Number of events 4
General disorders Elevated Temperature	71.4% 5/7 • Number of events 7
Gastrointestinal disorders Vomiting and/or Nausea	28.6% 2/7 • Number of events 2
Infections and infestations Bronchitis	14.3% 1/7 • Number of events 1
Infections and infestations Meibomian cyst infected	14.3% 1/7 • Number of events 1
Respiratory, thoracic and mediastinal disorders Nasal congestion	28.6% 2/7 • Number of events 2
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	57.1% 4/7 • Number of events 4

Additional Information

Sriluck Simasathien ; Infectious Disease Consultant

Department of Pediatrics, Pharamongkutklao Hospital

Phone: 66-2-644-8971

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place