A clinical study for assessment of safety and efficacy of single-dose of intravenously administered Dengue monoclonal antibody in Children more than or equal to 5 Years and Adults with Dengue.

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicentric Study of Dengue Monoclonal Antibody in Children more than or equal to 5 Years and Adults with Dengue - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082301

Enrollment

500

Registered

2025-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: B978- Other viral agents as the cause ofdiseases classified elsewhere

Interventions

Intervention1: Dengue-mAb - 6 mg/kg: Dengue-mAb 6mg/kg (0.24 mL/Kg) will be administered by IV infusion Control Intervention1: Placebo: Placebo is the formulation containing all ingredients as Dengue-

Eligibility

Inclusion criteria

Inclusion criteria: 1. The study participants will be Children 5 years and adults. 2. Participants or parents who give written informed consent. 3. History of fever within 48 hours from onset. 4. Positive for dengue virus infection by NS1 test (rapid test). 5. Participants who are willing to be hospitalized post infusion for a period of at least 72 hours of afebrile period.

Exclusion criteria

Exclusion criteria: 1. Patient meets criteria for Severe Dengue 2. History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders. 3. History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed)

Design outcomes

Primary

Measure	Time frame
Viral Log Reduction [VLR] (overall) of infective dengue virus measured by NS1 ELISA based TCID50 test (NSET) AND/OR Time to clearance of feverTimepoint: at 8 hours after IP administration AND/OR Ã¢â?¬Â¢apyrexia for 72 hours after IP administration	—

Secondary

Measure	Time frame
VLR of infective dengue virus measured by NSET (by serotype & baseline serostatus)Timepoint: 8 hours after IP administration;VLR of infective dengue virus measured by NSET (overall, by serotype & baseline serostatus)Timepoint: at 24, 48 & 72 hours after IP administration;VLR of dengue viral load measured by qRT-PCR (overall, by serotype & baseline serostatus)Timepoint: at 24 & 48 hours after IP administration;Trend of platelet count, leukocyte count & hematocritTimepoint: Day1 to day 8	—

Measure

Time frame

VLR of infective dengue virus measured by NSET (by serotype & baseline serostatus)Timepoint: 8 hours after IP administration;VLR of infective dengue virus measured by NSET (overall, by serotype & baseline serostatus)Timepoint: at 24, 48 & 72 hours after IP administration;VLR of dengue viral load measured by qRT-PCR (overall, by serotype & baseline serostatus)Timepoint: at 24 & 48 hours after IP administration;Trend of platelet count, leukocyte count & hematocritTimepoint: Day1 to day 8

—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni MD

Serum Institute of India Pvt. Ltd.

drpsk@seruminstitute.com912026993900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026