A clinical study for assessment of safety and immunogenicity of Dengusiil vaccine in Indian adults and children.

A Seamless Phase 1/2, double blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of Dengusiil in Indian adults and children of more than 2 years of age - Dengusiil-02

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061776

Enrollment

120

Registered

2024-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Intervention1: Dengusiil vaccine: Dengusiil is provided as a single dose lyophilized powder containing live attenuated DENV serotypes 1 to 4 to be reconstituted with 0.5 mL sterile water for injection

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy adults aged 18-60 years of age - adult cohort 2. Healthy children aged more than 2 to less than 18 years of age for pediatric cohort 3. Participants who give written informed consent and or assent for children of more than 12 to less than 18 years of age

Exclusion criteria

Exclusion criteria: 1. Previous dengue vaccination. 2. Presence of acute infection in the preceding 14 days or presence of a temperature more than 38 degree celcious or acute symptoms of infection greater than of mild severity on the day of vaccination 3. Participation or planned participation in a study involving the administration of an investigational product within the past one month or during this study period. 4. A family history of congenital or hereditary immunodeficiency. 5. Women who are pregnant, breast-feeding, or considering becoming pregnant. All participants of childbearing potential must agree to use medically acceptable forms of contraception from screening until 60 days post vaccination.

Design outcomes

Primary

Measure	Time frame
1. The occurrence and severity of solicited local and systemic reactions 2. The occurrence, severity, and relatedness to vaccination of unsolicited adverse eventsTimepoint: 21 days following vaccination	—

Secondary

Measure	Time frame
Geometric mean titers (GMTs)Timepoint: Day 1, 85 and 181;Neutralizing antibodiesTimepoint: Day 85 and Day 181	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni MD

Serum Institute of India Private Limited, Pune

drpsk@seruminstitute.com912071946836

Outcome results