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A double-blind, randomised, controlled trial to compare allergic outcomes in children following vaccination with acellular pertussis antigen given at 2 months of age versus whole cell pertussis in the infant vaccine schedule

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Trial Profile

A double-blind, randomised, controlled trial to compare allergic outcomes in children following vaccination with acellular pertussis antigen given at 2 months of age versus whole cell pertussis in the infant vaccine schedule

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 22 Feb 2022

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At a glance

  • Drugs Hib-DTP-hepatitis B vaccine (Primary) ; DTaP poliovirus vaccine; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Hib-DTaP-hepatitis B-poliovirus vaccine
  • Indications Pertussis
  • Focus Adverse reactions
  • Acronyms OPTIMUM
  • Most Recent Events

    • 07 Feb 2022 Results published in the Trials
    • 12 Feb 2021 Time frame changed from 18 months of age to 12 months of age. Planned number of patients increased. Additional clarification of Infanrix Hexa as acellular has been provided.
    • 12 Feb 2021 Planned number of patients changed from 150 to 3000.

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