evel of immunity and safety of two types of vaccines administered for the prevention ofJapanese encephalitis in an interchangeable dosing schedule among healthy Indian children: Amulti-centric study

Not Applicable

• Registration Number: CTRI/2023/07/055155
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

A child will be included in the study if all of the following criteria are fulfilled:

1.Healthy, as established by medical history and clinical examination by a pediatrician.

2.Age between 9-12 months at the time of enrolment.

3.Parental ability and willingness to provide informed consent.

4.Parents (or legal guardian) who have been residents of the study area for atleast the past 6 months and intend to remain in the area with the child during the study period.

Exclusion Criteria

Any of the following conditions will exclude children from the study:

1.Presence of febrile illness in the previous 72 hours or on the day of enrolment (temporary exclusion).

2.Acute disease at the time of enrolment (temporary exclusion).

3.Concurrent participation in another clinical trial throughout the entire timeframe for this study.

4.History of severe hypersensitivity reaction to injections including other vaccines received in past

5.Presence of significant malnutrition (weight-for-height z-score <-3SD median)

6.Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease), congenital or acquired, as determined by medical history and/or physical examination.

7.Acute infectious disease, active tuberculosis; otitis media

8.History of epilepsy and any diagnosed neurological disorder

9.Known or suspected impairment of immunological function based on medical history and physical exam.

10.Prior receipt of JE vaccine.

11.Receipt of any immunoglobulin therapy and/or blood products since birth.

12.H/O chronic administration ( >14 days) of immunosuppressants including corticosteroids.

13.Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participantâ??s parentsâ?? ability to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sero-protection: PRNT50 titer of 1:10 will be <br/ ><br>considered as seropositive <br/ ><br>Seroconversion: PRNT50 Titer of 1:10 if the <br/ ><br>baseline titer was 10 or a 4-fold increase if the <br/ ><br>baseline titer was 10. Sero-protection: PRNT50 titer of 1:10 will be <br/ ><br>considered as seropositive <br/ ><br>Seroconversion: PRNT50 Titer of 1:10 if the <br/ ><br>baseline titer was 10 or a 4-fold increase if the <br/ ><br>baseline titer was 10Timepoint: 28 days after the second dose of JE vaccine

Secondary Outcome Measures

Name	Time	Method
Immediate post-vaccination reactogenicity <br/ ><br>Solicited post-vaccination reactions <br/ ><br>Unsolicited vaccine-related AEs <br/ ><br>SAEs through out the study periodTimepoint: 1. within 30 min post-vaccination) <br/ ><br>2. Post-vaccination reactions (until 7 days) <br/ ><br>3. Occurrence of unsolicited adverse events until <br/ ><br>28 days after each vaccine dose, <br/ ><br>4. Vaccine-related serious adverse events <br/ ><br>(SAEs), at any time through the end of the study.