Not Yet RecruitingPhase 2ACTRN12609000905268

Immunogenicity and safety of acellular pertussis (whooping cough) vaccine at birth

Immunogenicity and safety of acellular pertussis vaccine given at birth in healthy infants

Sponsor

Peter McIntyre

Enrollment

400 participants

Start Date

Nov 28, 2009

Study Type

Interventional

Conditions

whooping cough (pertussis)

Summary

In Australia, many hospitalisations and deaths from whooping cough (pertussis) occur in babies less than 2 months old. Currently when babies are between 6-8 weeks old they are given a vaccine against pertussis. The aim of this study is to see if giving babies the pertussis vaccine (Pa vaccine) earlier than 6 weeks old means that they are better protected. This study is looking at just how early antibodies to protect against pertussis develop and whether babies given either one dose at birth and again at 6 weeks old or just at 6 weeks will make antibodies earlier than the current schedule. This study is also being conducted in Adelaide, Melbourne and Perth.

Eligibility

Sex: Both males and femalesMin Age: 1 HoursMax Age: 5 Dayss

Plain Language Summary

Simplified for easier understanding

This study tests the safety and immune response of giving whooping cough vaccine to newborn babies at birth instead of waiting until the usual age. It is for healthy newborns born at 37 weeks or later, within the first 5 days of life.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

We will ask mothers who have had a whooping cough booster vaccine in the last 5 years and with their permission check with your local doctor the date this was given. If parents agree to their baby pa

We will ask mothers who have had a whooping cough booster vaccine in the last 5 years and with their permission check with your local doctor the date this was given. If parents agree to their baby participating in this study, he or she will be randomly placed into one of two groups. One group will be given two vaccines monovalent acellular pertussis vaccine (Pa vaccine 0.5 ml) and Hepatitis B vaccine ( 0.5 ml) shortly after birth. The other group will only be given the Hepatitis B vaccine at birth. Both groups will then be given the recommended vaccines at 6 weeks, 4 and 6 months old according to the Australian Standard Vaccination Schedule. Although the first vaccine dose is currently recommended at 8 weeks, all vaccines are approved for use from 6 weeks of age.

Locations(1)

Australia

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ACTRN12609000905268