A Phase IV, single dose JENVAC (Inactivated JE Vaccine) vs. Chinese SA-14-14-2 (Live JE Vaccine) vaccine

A Phase IV, single dose, open labelled, comparative, randomized controlled study to evaluate the immunogenicity and safety of BBILâ??s JENVAC (Inactivated JE Vaccine) vs. Chinese SA-14-14-2 (Live JE Vaccine) vaccine in healthy volunteers - JENVAC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/02/004386

Enrollment

360

Registered

2014-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: JENVAC: purified inactivated JE vaccine, JENVAC manufactured By BBIL, Liquid 0.5mL of JENVAC will be injected as single dose on day 0 by intramuscular route. Control Intervention1: SA 1

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy volunteers of 1 to 15 years age group (inclusive) without significant medical history or abnormal findings at screening 2.Parents/legal representative willing to give signed written Informed Consent. 3.Available for all study related visits and procedures for the entire duration of the study, without any known exposure to JE prior to the first screening visit based on previous clinical history.

Exclusion criteria

Exclusion criteria: 1.Subjects with the age less than 1 year or more than 15 years. 2.Fever of any origin of duration more than 3 days within one month prior to screening or on the day of screening. 3.History of malaise, headache, anorexia at the time of screening or during the administration of the vaccine under study. 4.Past history of JE infection. 5.Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, haematological or immune disorders. 6.History of allergic diseases. 7.Any confirmed or suspected immunosuppressive or immunodeficient condition 8.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for JE or other vaccine in the past 2 months. 9.Previous history of hypersensitive reaction to vaccine or vaccine component.

Design outcomes

Primary

Measure	Time frame
Immunogenicity: To determine the seroconversion of JE antibody titers after single dose vaccine administration as compared to baseline of test vaccine To evaluate and compare the seroconversion and GMTs of test and reference vaccine as compared to baseline. NOTE: Proportion of participants that are seronegative at baseline (1:10) will require a PRNT50 titer of â?¥1:10 to meet the criteria for seroconversion. Timepoint: To evaluate the seroconversion of JE antibody titers at day 28, day56, day 90, day 180 and day 360 as compared to baseline of test vaccine. Comparison of GMT and Seroconversion of JE antibodies day 28,day 56, day 90, day 180 and day 360 between the study groups.	—

Measure

Time frame

Immunogenicity: To determine the seroconversion of JE antibody titers after single dose vaccine administration as compared to baseline of test vaccine To evaluate and compare the seroconversion and GMTs of test and reference vaccine as compared to baseline. NOTE: Proportion of participants that are seronegative at baseline (1:10) will require a PRNT50 titer of â?¥1:10 to meet the criteria for seroconversion. Timepoint: To evaluate the seroconversion of JE antibody titers at day 28, day56, day 90, day 180 and day 360 as compared to baseline of test vaccine. Comparison of GMT and Seroconversion of JE antibodies day 28,day 56, day 90, day 180 and day 360 between the study groups.

—

Secondary

Measure	Time frame
Safety: To assess and compare the safety of test and reference vaccine when administered as single dose.Timepoint: one year	—

Countries

India

Contacts

Public ContactDr B N Patnaik

Bharat Biotech International Ltd.

badri2299@bharatbiotech.com04023480567

Outcome results