A post licensure study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus reduced Diphtheria (Td) Vaccine in healthy ≥7 year old Indian children, adolescents and adults in comparison with a marketed Td vaccine.

Phase 4

Completed

• Conditions: For active immunization for the prevention of disease caused by Tetanus and Diphtheria.; Encounter for immunization,

• Registration Number: CTRI/2013/09/004032
• Lead Sponsor: Biological E Limited

Brief Summary

This is a Multicentre, open label, parallel, randomized (2:1) phase-IV non-inferiority study.There will be a total of 270 healthy subjects of either sex who will be randomised into two treatment arms viz., BE’s Td vaccine group and SIIL’s Td vaccine group. There would be two age subsets in each of the treatment arms. Healthy children, adolescents between ≥7 to <18 years of age would be enrolled in group-1 and healthy adults of ≥18 years of age would be enrolled in group-2 in both treatment arms.

The objective of this phase-IV study is to assess the immunogenicity and safety of BE’s licensed Td vaccine (BE Td®) in ≥ 7 year old children, adolescents and adults of either gender in comparison with SIIL’s licensed (Sii Td-Vacâ„¢) vaccine. This vaccine to be administered intramuscularly in a single booster dose schedule.



Antibody titre estimation and rotuine laboratory investigations will performed twice during the study i.e., once before administration of the booster dose and again 30 days after the administration of booster dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-10
• Study Completion: 2014-04-01
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• 1.Written informed consent from the subject or subject’s parent/guardian or subject’s legally acceptable representative 2.Informed assent directly from the child/adolescent aged between ≥7 to <18 years in addition to consent from subject or his/her LAR, except when the subject is incapable of providing it because of immaturity or cognitive abilities as judged by the Investigator.
• 3.Healthy Indian subjects of either gender between ≥7 to <18 years in child/adolescent age subset and ≥18 years of age in adult age subset at the time of vaccination.
• 4.Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >103.5°F [>39.5°C]).
• 5.History of previous primary immunisation with DTP vaccine at childhood.
• 6.Willingness of subject or subject’s parent/guardian or their legally acceptable representative not to participate in any other clinical trial during the course of study.
• 7.Subject or subject’s parent/guardian or subject’s legally acceptable representative willing to comply with the protocol requirements.
• 8.Subjects who were not receiving any immunosuppressive therapy.
• 9.Subjects without contraindications or precautionary circumstances.

Exclusion Criteria

• 1.History of Tetanus (TT) or Tetanus with reduced diphtheria (Td) booster vaccination within last 5 years.
• 2.Subjects with acute disease at the time of enrolment, defined as “presence of a moderate or severe illnessâ€.
• 3.Life-threatening or serious cardiac, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematologic or immunologic disorder.
• 4.Subjects with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
• 5.Pregnant women and women with childbearing potential not following proven contraceptive methods.
• 6.Subjects on immunosuppressive or immunostimulant therapy.
• 7.Any confirmed or suspected immunosuppressive or immunodeficient condition.
• 8.Known case of hypersensitivity to any of the components of Td vaccine.
• 10.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
1.Number and percentage of subjects achieving seroprotection levels of anti-Tetanus and anti-Diphtheria antibodies.	1.At day 30 in both the treatment arms across target age subsets | 2.At day 30 post single booster dose
2.Two sided 95% confidence intervals for the difference in proportions of subjects achieving seroprotection rates of anti-Tetanus and anti-Diphtheria antibody titres	1.At day 30 in both the treatment arms across target age subsets | 2.At day 30 post single booster dose

Secondary Outcome Measures

Name	Time	Method
1.Geometric Mean Titres (GMT)	2.Two fold and four fold rise in anti-Tetanus and anti-Diphtheria antibody titres.

Trial Locations

Locations (5)

Aadithya Adhikari Hospital; 🇮🇳 Mysore, KARNATAKA, India

K.R.Hospital; 🇮🇳 Mysore, KARNATAKA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Oyster and Pearl Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Sant Dnyaneshwar Medical Education & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Aadithya Adhikari Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Haridas Upadya

Principal investigator

09880046375

dr.upadya@gmail.com