None listed
Conditions
Brief summary
This study aims to protect infants and young children from whooping cough, also known as pertussis, by finding a more effective timing for immunisations. Possibly the best way to prevent whooping cough in early infancy and also in 3-5 year olds may be by a vaccine schedule consisting of two early doses in infancy (6 and 12 weeks old) and a third dose at 11-12 months old. This study aims to look at whether an alternate pertussis vaccination schedule (given at 6 weeks, 12 weeks and 11-12 months old), gives the same immune protection as the current pertussis vaccination schedule (at 6 weeks, 4 months and 6 months old).
Interventions
Changed timing for the administration of the pertussis-containing vaccine known as Infanrix hexa (contains diphtheria, tetanus, acellular pertussis, hepatitis B, polio and haemophilus influenza B antigens), which is given to all Australian children as part of the National Immunisation Program. That is, for the study participants, only the timing has been altered for Infanrix hexa vaccination and not the vaccine itself.
The study schedule is that Infanrix hexa is given at 6 weeks, 12 weeks, an
Changed timing for the administration of the pertussis-containing vaccine known as Infanrix hexa (contains diphtheria, tetanus, acellular pertussis, hepatitis B, polio and haemophilus influenza B antigens), which is given to all Australian children as part of the National Immunisation Program. That is, for the study participants, only the timing has been altered for Infanrix hexa vaccination and not the vaccine itself. The study schedule is that Infanrix hexa is given at 6 weeks, 12 weeks, and 11 months old (compared to the standard schedule of 12 weeks, 4 months and 6 months old). The vaccine will be administered by intramuscular injection by a registered nurse or doctor with specialisation in immunisation. The vaccination will be recorded in the subject's study documentation, the subject's personal immunisation record (known as the Blue Book in NSW), and on the Australian Childhood Immunisation Register.
Sponsors
The Sydney Children's Hospitals Network
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
42 Days to 7 Weeks
Healthy volunteers
Yes
Inclusion criteria
Eligible infants of English-speaking parents must be healthy (by history and physical examination) at the time of the first vaccine, born at 36 completed weeks gestation or greater, between 6-7 weeks of age at the time of enrolment, and whose parents give written informed consent.
Exclusion criteria
Infant has received the 6 week old vaccines. Contraindications to vaccination as listed in the current NHMRC Australian Immunisation Handbook (at time of study 10th edition, online access http://www.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home). The relevant 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). Infant of a mother known to be a carrier of hepatitis B virus. Administration of immunoglobulins and any blood products preceding the first dose of study vaccine or planned administration during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, in child. Major congenital defects or serious chronic illness. Neurologic disease or seizure.
Outcome results
None listed