Follow up of immunogenicity and safety of acellular pertussis vaccine given at birth to 4 years of age

Phase 3

Completed

• Conditions: Pertussis immunogenicity; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12614001325695
• Lead Sponsor: The Sydney Children's Hospitals Network

Brief Summary

In 2010 when this study began, Australian infants < 5 months old and children aged 2-4 years were highly susceptible to pertussis disease and were overrepresented in case numbers. This was suspected to largely be driven by gaps in immune-protection because the vaccine schedule did not include a booster dose during the second year of life. We proposed these gaps could be overcome by the addition of a birth dose of a pertussis vaccine and the (re)-introduction of a booster dose at 18-months of age into the childhood immunisation schedule. Here we present the long-term (4-year) antibody follow up of children administered an additional birth dose of pertussis vaccine or who received the standard DTPa schedule in infancy and then received either a high-dose DTPa (Infanrix), low-dose dTpa (Boostrix) or did not return (no 18-month booster). Antibodies to pertussis were measured before and after a booster dose 4-years. By 4 years of age, most children who were not administered a booster dose at 18 months had antibody levels at or below those associated with pertussis seropositivity. This supports the current recommendation for a pertussis booster dose in the second year of life. All children responded to a booster dose of either low or high dose vaccine at 4 years. These results support the current national immunization program in Australia which recommends a booster dose of a pertussis/tetanus/diphtheria vaccine at 4 years of age.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-17
• Study Completion: 2017-02-02
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Children who are between 4 years and 4 years 364 days old are eligible to participate in this study and who are subjects previously enrolled in the First Phase study.
(ACTRN12609000905268)

Exclusion Criteria

1. Contraindications to vaccination as listed in the current NHMRC Australian Immunisation Handbook 10th Edition or as listed in the Infanrix-IPV or Boostrix-IPV Product Information. DTPa-IPV or dTpa-IPV 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).
2. Evidence of a second booster diphtheria, tetanus, pertussis vaccination since completion of the first booster vaccine at 18- 24 months old.
3. Administration of immunoglobulins or any blood products within the 3 month period prior to the first visit; in which case, a delay in enrolment will be considered in the absence of other excluding criteria.
4. Any confirmed or suspected immunosuppressive or immunodeficient condition contraindicating MMR vaccination.
5. History of serious chronic illness or condition which in the judgement of the clinical investigator would preclude study participation.
6. History of neurologic disease or seizure (excluding simple febrile seizure).
7. Must not have had the vaccinations scheduled for age 4 years (ie Infanrix-IPV and measles mumps rubella vaccine).

Study & Design

• Study Type: Interventional
• Study Design: Not specified