Optimising pertussis vaccination in infants: a new approach. Effects of delaying the third pertussis vaccine to 11 months old.
Comparing the immunogenicity and safety of healthy infants who receive a delayed third dose of pertussis vaccine to those vaccinated according to the standard Australian vaccination schedule.
The Sydney Children's Hospitals Network
80 participants
Jun 11, 2013
Interventional
Conditions
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).
Eligibility
Inclusion Criteria1
- 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 Criteria7
- 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.
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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, 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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12615000898550