A phase IV clinical trial to study the safety and immunogenicity of a single booster dose of BEs Tetanus Toxoid vaccine BETT administered to 18-50 year old healthy Indian adults of either gender.

A multicentric, single blind, parallel, randomized phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Toxoid vaccine BETT administered to healthy Indian adults of either gender aged between 18-50 years in comparison with the marketed ShanTTÂ® vaccine - A non-inferiority study. - None

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000539

Enrollment

Registered

2009-07-17

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

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: BE&#039

s Adsorbed Tetanus vaccine B.P. (BETT): 0.5mL single booster dose given intramuscularly. Control Intervention1: Tetanus Toxoid vaccine (ShanTT&reg

): 0.5mL single booster dose given intramuscularly.

Eligibility

Inclusion criteria

Inclusion criteria: 1) Written informed consent obtained from the subject or his/her legally acceptable representative; 2) Healthy Indian subjects of either gender aged between 18-50 yrs of age; 3) Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >39.5 degrees); 4) History of previous immunisation with TT; 5) Subjects without any history of contagious diseases.

Exclusion criteria

Exclusion criteria: 1) Subjects with acute disease at the time of enrolment, defined as presence of a moderate or severe illness; 2) Clinical or serological findings suggestive of any contagious disease at the time of screening; 3) Known case of hypersensitivity to any of the components of TT vaccine; 4) Known history of any Serious Adverse Reaction (SAR) with previous TT immunizations in the individual to be immunized; 5) Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.

Design outcomes

Primary

Measure	Time frame
Non-inferiority(NI)assessment by proportionsTimepoint: Non-inferiority margin set at -10% assessed after 30 days of single booster dose.	—

Secondary

Measure	Time frame
1. Non-inferiority (NI) by Geometric Mean titer ratio; 2. Anti-Tetanus booster responses assessed by fold increase in titers; 3. proportion of subjects seroconverted (SCR &#8805;0.01 IU/mL) and seroprotected (SPR &#8805;0.1 IU/mL). 4. Occurrence of solicited and unsolicited local and general adverse eventsTimepoint: 1. Ratio set at > 1/1.5 assessed 30 days after single booster dose. 2. 30 days after single booster dose 3. 30 days after single booster dose. 4.first 7 days after single dose and next 28 days thereafter and serious adverse events during the entire study period.	—

Measure

Time frame

1. Non-inferiority (NI) by Geometric Mean titer ratio; 2. Anti-Tetanus booster responses assessed by fold increase in titers; 3. proportion of subjects seroconverted (SCR &#8805;0.01 IU/mL) and seroprotected (SPR &#8805;0.1 IU/mL). 4. Occurrence of solicited and unsolicited local and general adverse eventsTimepoint: 1. Ratio set at > 1/1.5 assessed 30 days after single booster dose. 2. 30 days after single booster dose 3. 30 days after single booster dose. 4.first 7 days after single dose and next 28 days thereafter and serious adverse events during the entire study period.

—

Countries

India

Contacts

Public ContactDr.T.S.A.Kishore

kishore.tsa@biologicale.co.in04030214046

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026