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.

Phase 4

Completed

• Conditions: Health Condition 1: Z23- Encounter for immunization

• Registration Number: CTRI/2009/091/000539
• Lead Sponsor: Biological E Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2009-09-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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