Title: “A Phase II/III, Multicenter, Randomized, Open Label, Active Controlled, Clinical Study to Assess The Immunogenicity And Safety Of Tetanus Toxoid, Diphtheria Toxoid, And Acellular Pertussis (Tdap) Vaccine Manufactured By Serum Institute Of India Pvt. Ltd (SIIPL) In Comparison With Boostrix® Vaccine Of GSK In Healthy Adults, Adolescents And Children In India” is ongoing at KEMHRC, Vadu.

Sponsor: Sponsored by Serum Institute of India Pvt ltd.

Objective: The Primary Objective of this study is to assess the Reactogenicity and safety of single dose of Tdap and Boostrix® vaccines in healthy subjects of age 4-65 yrs. End Points of the study are: Incidence of adverse events during initial 30 minutes after Tdap or Boostrix® vaccination. Incidence of solicited adverse events during 7-day follow-up period after Tdap or Boostrix® Vaccination. Incidence of adverse events during 30-day follow-up period, post vaccination with Tdap and Boostrix® Pertussis remains an important worldwide public health problem it is a highly infectious disease even in countries with sustained high vaccination coverage. Despite established infant immunization programmes, Pertussis continues to circulate, predominantly due to waning immunity beyond childhood and disease transmission from adolescents and adults to vulnerable infants. The need to maintain antibody levels against Pertussis beyond Childhood, through booster vaccines is therefore increasingly recognized. Vaccination against Pertussis using available pediatric formulation was not recommended to immunize adolescent and adult population therefore reduced antigen content combined diphtheria-tetanus-acellular Pertussis (Tdap) vaccine has been specifically developed. Eligible participant will be randomized in 1:1 ratio to receive either a single dose of Tdap vaccine of SIIPL or Boostrix® vaccine of GSK. Randomization will be stratified based on following age cohorts:

• Cohort 1 – Healthy adults of age ≥18 years to 65 years

• Cohort 2 – Healthy Adolescents of age between10 years to < 18 years

• Cohort 3 – Healthy Children of age between 4 years to < 10 years


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