Safety and immunogenicity assessment of Tdap vaccine in healthy adults, adolescent and children.

Phase 2/3

Completed

• Conditions: Encounter for immunization,

• Registration Number: CTRI/2018/06/014617
• Lead Sponsor: Serum Institute of India Pvt Ltd

Brief Summary

This is amulticenter, randomized, active controlled, open label Phase II/ III clinicalstudy to assess the immunogenicity and safety of Tdap vaccine manufactured bySIIPL in comparison with Boostrix® vaccine of GSK. Healthy adults, adolescentsand children will be enrolled in the study. Eligible participants will berandomized in a 1:1 ratio. A single 0.5 mL dose of the vaccine (Tdapvaccine by SIIPL or Boostrix®) will be administered by intramuscular injection.The objective of the trial is to demonstrate immunogenic non-inferiority ofTdap vaccine compared to Boostrix® and to assess the reactogenicity andsafety of single dose of Tdap vaccine in comparison with Boostrix®.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-07
• Study Completion: 2020-06-20
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1 Healthy male or female subjects aged 4 years to 65 years on the day of enrollment 2 Healthy subjects as established by medical history, physical examination during screening and as per the clinical judgment of the Investigator 3 Sexually active participants to be using an effective method of contraception 30 days prior to the enrollment and throughout the study period 4 Subjects/ parent willing to provide assent or written informed consent 5 Subjects/ parent willingness and ability to comply with the requirements of the protocol.

Exclusion Criteria

• 1.History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except Tetanus-prone wound management for adults and/or for tetanus vaccination in pregnant women) in the past 5 yrs.
• 2.History of Tetanus, diphtheria or pertussis infection 3.History of administration of any vaccine within 30 days prior to administration of study vaccine or planned during the course of study participation.
• 4.History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
• 5.History of anaphylactic shock.
• 6.History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability or blood dyscrasias.
• 7.History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with a vaccine containing a pertussis component.
• 8.History of neurological complications following an earlier vaccination against diphtheria and/or tetanus.
• 9.Acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination.
• 10.Receipt of any oral or injectable antibiotics 5 days before enrollment.
• 11.History of any cancer, HIV infection, organ transplant or any other immune system disorder.
• 12.Chronic administration of immunosuppressant or other immune modifying drugs during the period starting six months prior to the study vaccine dose.
• 13.History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination.
• 14.Females who are pregnant, breastfeeding or planning to become pregnant.
• 15.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Percentage of subjects achieving the booster responses to diptheria toxoid 30 days after vaccination with Tdap and Boostrix	One month after the vaccination
4)Anti-PT, anti-FHA and antiPRN antibody GMCs 30 days after vaccination with Tdap and Boostrix	One month after the vaccination
2)Percentage of subjects achieving the booster responses to tetanus toxoid 30 days after vaccination with Tdap and Boostrix	One month after the vaccination
3)Percentage of subjects achieving booster response for PT, FHA and PRN 30 days after vaccination with Tdap and Boostrix	One month after the vaccination

Secondary Outcome Measures

Name	Time	Method
1)Percentage of subjects with seroprotection against Diphteria and Tetanus 30 days after vaccination	2)Percentage of seropositive subjects against Pertussis antigens 30 days after vaccination

Trial Locations

Locations (11)

Bharti Vidyapeeth Deemed University Medical college & Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Christian Medical College; 🇮🇳 Ludhiana, PUNJAB, India

Gleneagles Global Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Institute of Child Health; 🇮🇳 Kolkata, WEST BENGAL, India

JSS Hospital; 🇮🇳 Mysore, KARNATAKA, India

Kanchi Kamakoti Childs Trust Hospital; 🇮🇳 Chennai, TAMIL NADU, India

KEM Hospital Research centre; 🇮🇳 Pune, MAHARASHTRA, India

KLEs Dr Prabhakar Kore Hospital and Medical research Centre; 🇮🇳 Belgaum, KARNATAKA, India

M S Ramaiah Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sri Ramchandra Hospital; 🇮🇳 Chennai, TAMIL NADU, India

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Bharti Vidyapeeth Deemed University Medical college & Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Jitendra Oswal

Principal investigator

020-24364308

researchpedpune@gmail.com