NCT00249769

Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine

Completed Phase 3 Results posted Last updated 10 March 2020

What this trial tests

Phase 3 trial testing Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) in Encephalitis, Japanese B in 600 participants. Completed in 30 May 2006.

Timeline

21 November 2005

Primary endpoint
30 May 2006

30 May 2006

Quick facts

Lead sponsor	PATH
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	600
Start date	21 November 2005
Primary completion	30 May 2006
Estimated completion	30 May 2006
Sites	1 location across Philippines

Drugs / interventions tested

• Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) — full drug profile →
• Measles Vaccine (MV) — full drug profile →

Conditions studied

• Encephalitis, Japanese B — all drugs for Encephalitis, Japanese B →

Sponsor

PATH — full company profile →

Who can join

Adults 8 Months to 11 Months, any sex, with Encephalitis, Japanese B. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination Primary · Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)

Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.

Day 0

Group	Value	95% CI
LJEV Then MV	1.1	0.0 – 6.2
LJEV and MV	0.0	0.0 – 1.7
MV Then LJEV	0.0	0.0 – 2.1

Day 28

Group	Value	95% CI
LJEV Then MV	88.6	80.1 – 94.4
LJEV and MV	91.8	87.3 – 95.1
MV Then LJEV	86.5	80.6 – 91.2

Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination Secondary · Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)

Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).

Day 0

Group	Value	95% CI
LJEV Then MV	3.4	0.7 – 9.6
LJEV and MV	5.4	2.8 – 9.3
MV Then LJEV	6.1	3.1 – 10.7

Day 28

Group	Value	95% CI
LJEV Then MV	92.1	84.3 – 96.7
LJEV and MV	90.5	85.9 – 94.1
MV Then LJEV	90.6	85.3 – 94.4

Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination Secondary · Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)

Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.

Day 0

Group	Value	95% CI
LJEV Then MV	12.8	10.2 – 16.2
LJEV and MV	7.4	6.3 – 8.8
MV Then LJEV	7.0	5.8 – 8.5

Day 28

Group	Value	95% CI
LJEV Then MV	318.9	273.0 – 372.6
LJEV and MV	301.9	269.0 – 338.9
MV Then LJEV	262.5	222.2 – 310.2

Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination Secondary · Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)

Assayed by plaque reduction neutralization test (PRNT).

Day 0

Group	Value	95% CI
LJEV Then MV	5.7	4.9 – 6.5
LJEV and MV	5.7	5.2 – 6.1
MV Then LJEV	5.9	5.3 – 6.6

Day 28

Group	Value	95% CI
LJEV Then MV	202.8	140.5 – 292.9
LJEV and MV	155.0	123.5 – 194.5
MV Then LJEV	139.4	109.5 – 177.5

Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV) Secondary · Up to 7 days after LJEV administration

Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.

Local reactions: any

Group	Value	95% CI
LJEV Then MV	27
LJEV and MV	53
MV Then LJEV	27

Local reactions: mild

Group	Value	95% CI
LJEV Then MV	19
LJEV and MV	48
MV Then LJEV	22

Local reactions: moderate

Group	Value	95% CI
LJEV Then MV	8
LJEV and MV	5
MV Then LJEV	5

Local reactions: severe

Group	Value	95% CI
LJEV Then MV	0
LJEV and MV	0
MV Then LJEV	0

Systemic reactions: any

Group	Value	95% CI
LJEV Then MV	58
LJEV and MV	97
MV Then LJEV	88

Systemic reaction: mild

Group	Value	95% CI
LJEV Then MV	34
LJEV and MV	53
MV Then LJEV	56

Systemic reaction: moderate

Group	Value	95% CI
LJEV Then MV	22
LJEV and MV	37
MV Then LJEV	30

Systemic reaction: severe

Group	Value	95% CI
LJEV Then MV	2
LJEV and MV	7
MV Then LJEV	2

Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine Secondary · Up to 7 days after measles vaccination

Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.

Local reactions: any

Group	Value	95% CI
LJEV Then MV	19
LJEV and MV	44
MV Then LJEV	61

Local reactions: mild

Group	Value	95% CI
LJEV Then MV	15
LJEV and MV	42
MV Then LJEV	50

Local reactions: moderate

Group	Value	95% CI
LJEV Then MV	4
LJEV and MV	2
MV Then LJEV	11

Local reactions: severe

Group	Value	95% CI
LJEV Then MV	0
LJEV and MV	0
MV Then LJEV	0

Systemic reactions: any

Group	Value	95% CI
LJEV Then MV	49
LJEV and MV	97
MV Then LJEV	122

Systemic reaction: mild

Group	Value	95% CI
LJEV Then MV	31
LJEV and MV	53
MV Then LJEV	77

Systemic reaction: moderate

Group	Value	95% CI
LJEV Then MV	13
LJEV and MV	37
MV Then LJEV	42

Systemic reaction: severe

Group	Value	95% CI
LJEV Then MV	5
LJEV and MV	7
MV Then LJEV	3

Number of Participants Experiencing Unsolicited Adverse Events (AE) Secondary · Up to 7 days post-vaccination

Any Adverse Event

Group	Value	95% CI
LJEV Then MV	35
LJEV and MV	43
MV Then LJEV	79

Related adverse event

Group	Value	95% CI
LJEV Then MV	0
LJEV and MV	4
MV Then LJEV	2

Serious adverse event

Group	Value	95% CI
LJEV Then MV	2
LJEV and MV	0
MV Then LJEV	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month for serious adverse events and 7 days for non-serious adverse events. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LJEV Then MV

Serious: 5/100 (5%)

Deaths: 0/100

LJEV and MV

Serious: 0/236 (0%)

Deaths: 0/236

MV Then LJEV

Serious: 7/235 (3%)

Deaths: 0/235

Serious adverse events (7 terms)

Reaction	System	LJEV Then MV	LJEV and MV	MV Then LJEV
Amoebiasis	Gastrointestinal disorders	—	—	—
Acute Gastroenteritis	Gastrointestinal disorders	—	—	—
Animal bite	Injury, poisoning and procedural complications	—	—	—
Urinary tract infection	Renal and urinary disorders	—	—	—
Bronchial Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Complex Febrile Seizure	Nervous system disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—

Other adverse events (31 terms — click to expand)

Reaction	System	LJEV Then MV	LJEV and MV	MV Then LJEV
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—	—	—
Acute rhinitis	Respiratory, thoracic and mediastinal disorders	—	—	—
Acute gastroenteritis	Gastrointestinal disorders	—	—	—
Acute bronchitis	Infections and infestations	—	—	—
Systemic viral infection	Infections and infestations	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—
Furuncle	Skin and subcutaneous tissue disorders	—	—	—
Bronchial asthma	Immune system disorders	—	—	—
Miliaria	Skin and subcutaneous tissue disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Post-extraction hematoma	Surgical and medical procedures	—	—	—
Acute otitis media	Infections and infestations	—	—	—
Acute Tonsillopharyngitis	Infections and infestations	—	—	—
Atopic dermatitis	Skin and subcutaneous tissue disorders	—	—	—
Bacterial conjunctivitis	Infections and infestations	—	—	—
Cellulitis	Infections and infestations	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—
Enteric fever	Infections and infestations	—	—	—
Impetigo contagious	Skin and subcutaneous tissue disorders	—	—	—
Infected wound	Injury, poisoning and procedural complications	—	—	—
Insect bite	Injury, poisoning and procedural complications	—	—	—
Intestinal parasitism	Gastrointestinal disorders	—	—	—
Maculo-papular lesions	Skin and subcutaneous tissue disorders	—	—	—
Oral candidiasis	Gastrointestinal disorders	—	—	—
Post-vaccination reaction	Surgical and medical procedures	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Roseola infantum	Infections and infestations	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—
Viral conjunctivitis	Eye disorders	—	—	—
Conjunctivitis	Eye disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—

Most-reported serious reactions: Amoebiasis, Acute Gastroenteritis, Animal bite, Urinary tract infection, Bronchial Asthma, Complex Febrile Seizure, Pneumonia.

Data from ClinicalTrials.gov NCT00249769 adverse events section.

Sponsor's own description

This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.