A Phase III Multicenter, Observer-Blinded, Randomized, Active Controlled, Immune Non-inferiority and Safety Study of Vi-DT Vaccine Compared to Typbar TCV® in Healthy 6 Months-45 Years Aged Nepalese Participants.

NCT03933098 Phase 3 UNKNOWN

This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose. The study objectives are: I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT) II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.

Details

Lead sponsor	International Vaccine Institute
Phase	Phase 3
Status	UNKNOWN
Enrolment	1800
Start date	2019-11-15
Completion	2021-01

Conditions

• Typhoid

Interventions

• Test Vaccine Vi-DT Typhoid conjugate
• Control Vaccine Typbar TCV®

Primary outcomes

• Seroconversion rate1 — 4 weeks (28 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0)
  Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
• Geometric Mean Titers (GMT)1 — 4 weeks after vaccination of Vi-DT
  Measurement of the Geometric Mean Titers (GMT) following 4 weeks after vaccination of three lots of Vi-DT

Countries

Nepal