None listed
Conditions
Brief 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.
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 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 bir
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.
Sponsors
Peter McIntyre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Hours to 5 Days
Healthy volunteers
Yes
Inclusion criteria
Healthy infants (by history and physical examination) at the time of first vaccine, born at 37 weeks gestation or greater whose parents give written informed consent.
Exclusion criteria
1.Contraindications to vaccination as listed in the Immunisation Handbook 9th Edition 2.Infant of mother known to be a carrier of hepatitis B virus 3.Administration of immunoglobulins and any blood products preceding the first dose of study vaccine or planned administration during the study period. 4.Any confirmed or suspected immunosuppressive or immunodeficient condition, in parent or child 5.Major congenital defects or serious chronic illness
Outcome results
None listed