Small Study of TT Vaccine

An open label, single-treatment, single period, single dose, clinical phase I study to assess the safety and tolerability of tetanus vaccine of M/s Bio Vaccines (India) Private Limited in healthy, adults subjects. - TT BVL PILOT

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010448

Enrollment

Registered

2017-11-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Tetanus Toxoid Vaccine: Singe Tetanus Toxoid Vaccine to be given in Healthy Human Volunteers Control Intervention1: Tetatus Vaccine: Before and after Immunogenicity

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Adult Subjects

Exclusion criteria

Exclusion criteria: NOT WILLING TO GIVE CONSENT

Design outcomes

Primary

Measure	Time frame
Proportion/percentage of subjects achieving seroconversion response against tetanus vaccine, 4 weeks after single booster doseTimepoint: Proportion/percentage of subjects achieving seroconversion response against tetanus vaccine, 4 weeks after single booster dose	—

Secondary

Measure	Time frame
â?¢ Incidence of solicited adverse events 7 days after the vaccine dose in the two treatment groupsTimepoint: 4 WEEKS	—

Countries

India

Contacts

Public ContactDr Sonali Kar

KIMS, KIIT University

sonsam72@yahoo.co.uk9438423273

Outcome results