Trial Outcomes & Findings for Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine (NCT NCT00412516)

NCT ID: NCT00412516

Last Updated: 2014-10-13

Results Overview

Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

519 participants

Primary outcome timeframe

24, 36 months post vaccination

Results posted on

2014-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 SA 14-14-2 followed by measles vaccine one month later	Group 2 Measles and SA 14-14-2 given concurrently Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)	Group 3 Measles vaccine followed by SA 14-14-2 one month later
Overall Study STARTED	93	212	214
Overall Study COMPLETED	93	212	214
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=93 Participants SA 14-14-2 followed by measles vaccine one month later	Group 2 n=212 Participants Measles and SA 14-14-2 given concurrently	Group 3 n=214 Participants Measles vaccine followed by SA 14-14-2 one month later	Total n=519 Participants Total of all reporting groups
Age, Continuous	20.6 months STANDARD_DEVIATION .4 • n=5 Participants	20.6 months STANDARD_DEVIATION .4 • n=7 Participants	20.6 months STANDARD_DEVIATION .4 • n=5 Participants	20.6 months STANDARD_DEVIATION .4 • n=4 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	114 Participants n=7 Participants	117 Participants n=5 Participants	277 Participants n=4 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	98 Participants n=7 Participants	97 Participants n=5 Participants	242 Participants n=4 Participants
Weight (kg)	10.2 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	10.2 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	10.2 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	10.2 units on a scale STANDARD_DEVIATION 1.4 • n=4 Participants
Height (cm)	78.7 cm STANDARD_DEVIATION 3.1 • n=5 Participants	77.8 cm STANDARD_DEVIATION 3.8 • n=7 Participants	78.1 cm STANDARD_DEVIATION 3.5 • n=5 Participants	78.0 cm STANDARD_DEVIATION 3.5 • n=4 Participants

PRIMARY outcome

Timeframe: 24, 36 months post vaccination

Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA

Outcome measures

Outcome measures
Measure	Group 1 n=93 Participants SA 14-14-2 followed by measles vaccine one month later	Group 2 n=212 Participants Measles and SA 14-14-2 given concurrently Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)	Group 3 n=213 Participants Measles vaccine followed by SA 14-14-2 one month later
Measles Seropositivity at 24 and 36 Months 24 months post vaccination	98.92 percentage of participants seropositive Interval 94.15 to 99.97	95.75 percentage of participants seropositive Interval 92.09 to 98.04	94.37 percentage of participants seropositive Interval 90.37 to 97.06
Measles Seropositivity at 24 and 36 Months 36 months post vaccination	94.62 percentage of participants seropositive Interval 87.9 to 98.23	91.39 percentage of participants seropositive Interval 86.73 to 94.82	91.04 percentage of participants seropositive Interval 86.36 to 94.52

SECONDARY outcome

Timeframe: 12 months post vaccination

Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA

Outcome measures

Outcome measures
Measure	Group 1 n=89 Participants SA 14-14-2 followed by measles vaccine one month later	Group 2 n=205 Participants Measles and SA 14-14-2 given concurrently Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)	Group 3 n=211 Participants Measles vaccine followed by SA 14-14-2 one month later
Measles Seropositivity at 12 Months	87.64 percentage of subjects seropositive Interval 78.96 to 93.67	87.32 percentage of subjects seropositive Interval 81.97 to 91.55	87.2 percentage of subjects seropositive Interval 81.93 to 91.4

SECONDARY outcome

Timeframe: 12 months, 24 months, and 36 months post vaccination

"Seropositive" defined as a person with neutralizing antibody against JE virus at a titer ≥ 1:10 in a 50% plaque-reduction neutralizing assay (PRNT-50)

Outcome measures

Outcome measures
Measure	Group 1 n=93 Participants SA 14-14-2 followed by measles vaccine one month later	Group 2 n=212 Participants Measles and SA 14-14-2 given concurrently Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)	Group 3 n=214 Participants Measles vaccine followed by SA 14-14-2 one month later
Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. 12 months post-JE vaccination	90.4 percentage of subjects seropositive Interval 81.9 to 95.8	83.5 percentage of subjects seropositive Interval 77.6 to 88.4	86.1 percentage of subjects seropositive Interval 80.6 to 90.6
Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. 24 months post-JE vaccination	81.1 percentage of subjects seropositive Interval 71.5 to 88.6	83.8 percentage of subjects seropositive Interval 77.8 to 88.6	80.7 percentage of subjects seropositive Interval 74.6 to 85.9
Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. 36 months post-JE vaccination	79.3 percentage of subjects seropositive Interval 69.3 to 87.2	82.7 percentage of subjects seropositive Interval 76.7 to 87.6	81.9 percentage of subjects seropositive Interval 75.8 to 87.0

SECONDARY outcome

Timeframe: 12, 24, 36 months post-JE vaccination

Neutralizing antibody titer determined using a 50% plaque-reduction neutralizing assay (PRNT-50) for JE virus

Outcome measures

Outcome measures
Measure	Group 1 n=93 Participants SA 14-14-2 followed by measles vaccine one month later	Group 2 n=212 Participants Measles and SA 14-14-2 given concurrently Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)	Group 3 n=214 Participants Measles vaccine followed by SA 14-14-2 one month later
Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. 12 months post-JE vaccination	108 GMT Interval 70.0 to 167.0	83 GMT Interval 61.0 to 108.0	77 GMT Interval 60.0 to 98.0
Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. 24 months post-JE vaccination	67 GMT Interval 46.0 to 99.0	64 GMT Interval 50.0 to 80.0	70 GMT Interval 54.0 to 92.0
Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination. 36 months post-JE vaccination	51 GMT Interval 37.0 to 71.0	47 GMT Interval 38.0 to 58.0	58 GMT Interval 45.0 to 73.0

Adverse Events

Group 1

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Anthony A Marfin, Director Japanese Encephalitis Vaccine Introduction and Sustainability Project

PATH

Phone: 2062853500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All results communication must be reviewed and approved by the sponsor. The sponsor has 60 days to review results communications and provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1 n=93 participants at risk SA 14-14-2 followed by measles vaccine one month later	Group 2 n=212 participants at risk Measles and SA 14-14-2 given concurrently Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)	Group 3 n=214 participants at risk Measles vaccine followed by SA 14-14-2 one month later
Gastrointestinal disorders Gastritis	1.1% 1/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Amoebiasis	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Ascariasis	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Bronchopneumonia	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	1.4% 3/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	1.4% 3/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Cholera	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Dengue Fever	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Gastroenteritis	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.94% 2/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	1.4% 3/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Lobar pneumonia	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Meningitis tuberculous	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Pneumonia	1.1% 1/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Upper respiratory tract infection	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	1.4% 3/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Urinary tract infection	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.93% 2/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Infections and infestations Viral rash	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Injury, poisoning and procedural complications Skull fracture	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
General disorders Developmental delay	0.00% 0/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.47% 1/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Metabolism and nutrition disorders Food intolerance	1.1% 1/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).
Nervous system disorders Febrile convulsion	1.1% 1/93 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/212 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).	0.00% 0/214 • Three years post vaccination Since no investigational products were administered to subjects during the course of this study, subjects were not actively monitored to detect adverse events (AEs). However, passive surveillance was maintained to note reports of events meeting the definition of a serious AE (SAE).