Trial Outcomes & Findings for Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children (NCT NCT01408537)

Last Updated: 2014-11-18

Results Overview

To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from \<10 on before first vaccination To \>= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer \>=10 before first vaccination, will not be included in immunogenicity evaluation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

152 participants

Primary outcome timeframe

28 days after second dose of JEVAC

Results posted on

2014-11-18

Participant Flow

The enrollment took place in 2 sites (Department of Tropical Pediatrics, Faculty of Tropical Medicine and Nopparat Rajathanee Hospital) from 3rd May 2010 to 10th August 2010. One hundred and fifty two subjects who illegible for the inclusion and exclusion criteria were enrolled in the study.

There was no subject who did not get the study vaccine after informed consent was signed.

Participant milestones

Participant milestones
Measure	JEVAC JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Overall Study STARTED	152
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	JEVAC JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	3
Overall Study Lost to Follow-up	3

Baseline Characteristics

Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JEVAC n=152 Participants JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Age, Categorical <=18 years	152 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	1.2 years STANDARD_DEVIATION 0.32 • n=93 Participants
Sex: Female, Male Female	73 Participants n=93 Participants
Sex: Female, Male Male	79 Participants n=93 Participants

PRIMARY outcome

Timeframe: 28 days after second dose of JEVAC

Population: There were 152 enrolled subjects in the study. However, 5 subjects had NT titer \>= 10 before first vaccination and one subject whom blood on 28days after second vaccination was not drawn due to withdrawn consent. Therefore, the number of subjects for the outcome measurement should be 146.

Outcome measures

Outcome measures
Measure	JEVAC n=146 Participants JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).	GMT of NT Before Booster Vaccine GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	GMT of NT Titer After Booster Vaccine GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	Poor Appetite After Vaccination Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.	Vomiting After Vaccination Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.	Urticaria After Vaccination Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.	Unsolicited AEs After Each Vaccination unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination	SAEs Entire the Study SAEs which occured entire the study period were recorded.
Seroconversion Rate After Primary Vaccination	100 percentage of seroconversion	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC

Population: 152 were enrolled, 1 withdrawn consent before second vaccine, 5 had NT \>= 10 before first vaccine, 146 included in D28 after second vaccine. At 1 year, 3 received JE vaccine outside the study, 3 lost follow up, 140 included in before booster, At D28 after booster, 1 could not draw blood, 139 included in D28 after booster.

To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.

Outcome measures

Outcome measures
Measure	JEVAC n=146 Participants JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).	GMT of NT Before Booster Vaccine n=140 Participants GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	GMT of NT Titer After Booster Vaccine n=139 Participants GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	Poor Appetite After Vaccination Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.	Vomiting After Vaccination Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.	Urticaria After Vaccination Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.	Unsolicited AEs After Each Vaccination unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination	SAEs Entire the Study SAEs which occured entire the study period were recorded.
Geometric Mean Titer of NT After Primary and Booster Vaccination	150.01 titer Interval 126.4 to 175.7	49.33 titer Interval 39.0 to 62.4	621.66 titer Interval 510.4 to 757.2	—	—	—	—	—

SECONDARY outcome

Timeframe: 7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively

Population: Determined AEs by number of injections 152 injection for the first dose 151 injection for the second dose 145 injection for the third dose

To determine the adverse events of JEVAC

Outcome measures

Outcome measures
Measure	JEVAC n=152 Participants JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).	GMT of NT Before Booster Vaccine n=152 Participants GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	GMT of NT Titer After Booster Vaccine n=152 Participants GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	Poor Appetite After Vaccination n=152 Participants Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.	Vomiting After Vaccination n=152 Participants Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.	Urticaria After Vaccination n=152 Participants Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.	Unsolicited AEs After Each Vaccination n=448 injections unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination	SAEs Entire the Study n=448 injections SAEs which occured entire the study period were recorded.
Adverse Events of Vaccine	79 events	5 events	3 events	24 events	36 events	3 events	63 events	21 events

SECONDARY outcome

Timeframe: 1 year after primary vaccination

Population: The analysis was excluded 5 subjects who had NT titer \>10 on D0

To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.

Outcome measures

Outcome measures
Measure	JEVAC n=140 Participants JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).	GMT of NT Before Booster Vaccine GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	GMT of NT Titer After Booster Vaccine GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer \>=10 before first vaccination and subjects received JE vaccine outside the study.	Poor Appetite After Vaccination Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.	Vomiting After Vaccination Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.	Urticaria After Vaccination Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.	Unsolicited AEs After Each Vaccination unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination	SAEs Entire the Study SAEs which occured entire the study period were recorded.
Neutralizing Antibody Persistence One Year After the Primary Vaccination	125 participants	—	—	—	—	—	—	—

Adverse Events

JEVAC

Serious events: 21 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	JEVAC n=152 participants at risk JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Respiratory, thoracic and mediastinal disorders pneumonia	3.9% 6/152 • Number of events 6 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Respiratory, thoracic and mediastinal disorders bronchitis	1.3% 2/152 • Number of events 2 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Gastrointestinal disorders diarrhea	2.6% 4/152 • Number of events 4 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Skin and subcutaneous tissue disorders skin infection	0.66% 1/152 • Number of events 1 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Nervous system disorders seizure	3.3% 5/152 • Number of events 5 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Infections and infestations infection (other)	1.3% 2/152 • Number of events 2 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Respiratory, thoracic and mediastinal disorders pharyngitis	0.66% 1/152 • Number of events 1 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).

Other adverse events

Other adverse events
Measure	JEVAC n=152 participants at risk JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	17.8% 27/152 • Number of events 27 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Respiratory, thoracic and mediastinal disorders bronchitis	2.0% 3/152 • Number of events 3 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Gastrointestinal disorders diarrhea	5.9% 9/152 • Number of events 9 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Gastrointestinal disorders vomiting	21.1% 32/152 • Number of events 36 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Skin and subcutaneous tissue disorders skin infection	0.66% 1/152 • Number of events 1 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Skin and subcutaneous tissue disorders pruritus	0.66% 1/152 • Number of events 1 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Skin and subcutaneous tissue disorders urticaria	2.0% 3/152 • Number of events 3 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Infections and infestations infection	4.6% 7/152 • Number of events 7 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Skin and subcutaneous tissue disorders contact dermatitis	8.6% 13/152 • Number of events 13 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Infections and infestations Fever	42.1% 64/152 • Number of events 79 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Infections and infestations chills	2.0% 3/152 • Number of events 3 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).
Gastrointestinal disorders poor appetite	14.5% 22/152 • Number of events 24 • In addition to systematic assessment on Day 0-14 after each vaccination, Any unsolicited AE was accessed within 28 days after each vaccination. Any SAE was accessed through the study period (1 yr +28 days).

Additional Information

Dr. Pornthep Chanthavanich

Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Thailand

Phone: 6623549161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place