Persistence of immunity and response to a booster dose of DTPa or dTpa vaccine at 18 months old following acellular pertussis vaccine given at birth in healthy infants

Not Applicable

Completed

• Conditions: Vaccine; Pertussis; Immunity persistence; Inflammatory and Immune System - Other inflammatory or immune system disorders; Infection - Other infectious diseases

• Registration Number: ACTRN12623000418673
• Lead Sponsor: The Sydney Children's Hospital Network

Brief Summary

Participants form the original study ACTRN12609000905268 were followed up to 18-36 months of age and immunogenicity measured pre and post a low dose dTap booster (Boostrix) vaccine. Results are pending and will be updated here when finalised

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-22
• Study Start: 2023-04-27
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Children who are between 18 to 36 months old and were subjects previously enrolled in the
First Phase study (ACTRN12609000905268) are eligible to participate in this study.
Eligible children must meet inclusion and exclusion criteria at the time of first planned visit and parents/guardians must give written informed consent.

Exclusion Criteria

Contraindications to vaccination as listed in the NHMRC Australian
Immunisation Handbook or as listed in the Infanrix Product
Information. DTPa or dTpa vaccine will not be administered to individuals known to be
hypersensitive to any component of the vaccine or residues carried over from
manufacture (such as formaldehyde and glutaraldehyde).

Administration of immunoglobulins and any blood products within the 3 month
period prior to the first visit or planned administration during the study period; in
which case, a delay in enrolment will be considered in the absence of other excluding
criteria.

Any confirmed or suspected immunosuppressive or immunodeficient condition.

History of serious chronic illness or condition which in the judgement of the clinical
investigator would preclude study participation.

History of neurologic disease or seizure

Must not have had a DTPa or dTpa booster vaccine in the second year of life (prior to study
enrolment)

Study & Design

• Study Type: Interventional
• Study Design: Not specified