Trial Outcomes & Findings for Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea (NCT NCT01900444)

NCT ID: NCT01900444

Last Updated: 2022-03-28

Results Overview

JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 119 participants
• Primary outcome timeframe: Day 0 (pre-booster) and Day 28 post-booster injection
• Results posted on: 2022-03-28

Participant Flow

Study participants were enrolled from 11 July 2013 to 27 September 2013 at 8 clinic centers in South Korea.

A total of 119 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.

Participant milestones

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Study STARTED	119
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Study Protocol Violation	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea

Baseline characteristics by cohort

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=119 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Age, Categorical <=18 years	119 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	2.62 Years STANDARD_DEVIATION 0.391 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants
Region of Enrollment South Korea	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection

Population: Seroprotection rates were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization Pre-Booster	93.5 Percentage of participants
Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization Post-Booster	100.0 Percentage of participants

PRIMARY outcome

Timeframe: Day 28 post-booster injection

Population: Seroconversion rates were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization	94.6 Percentage of participants

PRIMARY outcome

Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection

Population: Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using PRNT50 test.

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization Pre-Booster	165 Titer Interval 116.0 to 235.0
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization Post-Booster	8482 Titer Interval 6994.0 to 10286.0

PRIMARY outcome

Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection

Population: Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using PRNT50.

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization	51.4 Ratio Interval 37.3 to 71.0

PRIMARY outcome

Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection

Population: Seroprotection rates were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Pre-Booster; ≥12 months and <18 months	92.5 Percentage of participants
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥12 months and <18 months	100.0 Percentage of participants
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Pre-Booster; ≥18 months and <24 months	94.7 Percentage of participants
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥18 months and <24 months	100.0 Percentage of participants
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Pre-Booster; ≥24 months	100.0 Percentage of participants
Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥24 months	100.0 Percentage of participants

PRIMARY outcome

Timeframe: Day 28 post-booster injection

Population: Seroconversion rates were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥12 months and <18 months	96.2 Percentage of participants
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥18 months and <24 months	92.1 Percentage of participants
Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥24 months	100.0 Percentage of participants

PRIMARY outcome

Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection

Population: Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using PRNT50.

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization Pre-Booster; ≥12 months and <18 months	131 Titer Interval 5.0 to 5120.0
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization Post-Booster; ≥12 months and <18 months	8199 Titer Interval 320.0 to 20480.0
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization Pre-Booster; ≥18 months and <24 months	239 Titer Interval 5.0 to 20480.0
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization Post-Booster; ≥18 months and <24 months	8850 Titer Interval 160.0 to 20480.0
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization Pre-Booster; ≥24 months	20.0 Titer Interval 20.0 to 20.0
Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization Post-Booster; ≥24 months	10240 Titer Interval 10240.0 to 10240.0

PRIMARY outcome

Timeframe: Day 0 (pre-booster) and Day 28 post-booster injection

Population: Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.

JE virus neutralizing antibodies were measured using PRNT50.

Outcome measures

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=92 Participants Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥12 months and <18 months	62.3 Ratio Interval 2.0 to 1024.0
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥18 months and <24 months	37.0 Ratio Interval 1.0 to 1024.0
Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization Post-Booster; ≥24 months	512 Ratio Interval 512.0 to 512.0

Adverse Events

Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)

Serious events: 4 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=119 participants at risk Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Gastrointestinal disorders Ileus	0.84% 1/119 • Number of events 1 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Gastrointestinal disorders Intestinal obstruction	0.84% 1/119 • Number of events 1 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Cellulitis	0.84% 1/119 • Number of events 1 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Pneumonia	0.84% 1/119 • Number of events 1 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Injury, poisoning and procedural complications Forearm fracture	0.84% 1/119 • Number of events 1 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.84% 1/119 • Number of events 1 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Skin and subcutaneous tissue disorders Henoch Schonlein purpura	0.84% 1/119 • Number of events 1 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.

Other adverse events

Measure	Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) n=119 participants at risk Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Infections and infestations Nasopharyngitis	27.7% 33/119 • Number of events 36 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Injection site Pain	28.6% 34/119 • Number of events 34 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Injection site Erythema	14.3% 17/119 • Number of events 17 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Injection site Swelling	8.4% 10/119 • Number of events 10 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Fever	12.6% 15/119 • Number of events 15 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Nervous system disorders Headache	18.5% 22/119 • Number of events 22 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Malaise	40.3% 48/119 • Number of events 48 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
General disorders Myalgia	26.9% 32/119 • Number of events 32 • Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection. The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
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Restriction type: OTHER