CTRI/2023/07/055155
Not Yet Recruiting
N/A
Immunogenicity and safety of JENVAC and JEEV vaccines administered for prevention of Japanese encephalitis in an interchangeable dosing schedule among healthy Indian children: A multicentric, phase IV, open-labeled, randomized controlled trial - Nil
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indian Council of Medical Research
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy infants and children.Pneumococcal infectionRPCEC00000173Biomolecular Chemistry Center (CQB)
Completed
Phase 1
Heptavalent Conjugate Vaccine against Pneumococcal in healthy adults (VCN7-T).Pneumococcal infection.RPCEC00000133Biomolecular Chemistry Center (CQB)40
Completed
N/A
Safety and immunogenicity of meningococcus C conjugate vaccineMeningococcus C diseaseInfections and InfestationsMeningococcal infectionISRCTN37262487Bio-Manguinhos/Fiocruz (Brazil)60
Not Yet Recruiting
Phase 1
Safety and immune response of polio vaccines in healthy adultsACTRN12612000465853World Health Organization30
Completed
Phase 2
Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children.Pneumococcal infectionRPCEC00000182Biomolecular Chemistry Center (CQB)1,140