None listed
Conditions
Brief summary
Our First trial (ACTRN12609000905268) examined if giving babies the pertussis vaccine (Pa vaccine) earlier than 6 weeks old means that they are better protected. Children on this original trial are now being followed up to compare the pertussis immune responses and safety of a booster dose of either DTPa or low dose dTpa vaccine when given between 18-36 months old. we are hoping to find out if a lower dose diphtheria, tetanus and pertussis booster vaccine (dTpa) may provide comparable immune responses to the currently recommended DTPa vaccine however with a more favourable safety profile.
Interventions
All participants in this study will have participated in the neonatal pertussis vaccine trial (ACTRN12609000905268).
Participants on this initial study (ACTRN12609000905268) were randomised to two intervention groups at birth. One group received acellular pertussis vaccine and hepatitis B vaccine before 5 days old and the other group received only hepatitis B vaccine at birth.
In this follow on study participants from the original trial, both those who received acellular pertussis and hepatiti
All participants in this study will have participated in the neonatal pertussis vaccine trial (ACTRN12609000905268). Participants on this initial study (ACTRN12609000905268) were randomised to two intervention groups at birth. One group received acellular pertussis vaccine and hepatitis B vaccine before 5 days old and the other group received only hepatitis B vaccine at birth. In this follow on study participants from the original trial, both those who received acellular pertussis and hepatitis B vaccine at birth and those who received only hepatitis B vaccine at birth, were invited to receive either DTPa vaccine or a low dose dTpa vaccine at 18 months old. One intervention subgroup received a booster dose of Infanrix (Registered trademark) (DTPa) at 18 months of age. Each 0.5 mL monodose vial or pre-filled syringe of Infanrix contains: greater than or equal to 30 IU diphtheria toxoid greater than or equal to 40 IU tetanus toxoid equals 25 µg pertussis toxoid equals 25 µg filamentous haemagglutinin equals 8 µg pertactin Adsorbed onto 0.5 mg aluminium as aluminium hydroxide. The other intervention subgroup received a booster dose of Boostrix (Registered trademark) (dTpa) at 18 months old. Boostrix contains a lower amount of each of diphtheria, tetanus and pertussis antigens. Each 0.5 mL monodose vial or pre-filled syringe of Boostrix contains: greater than or equal to 2 IU diphtheria toxoid greater than or equal to 20 IU tetanus toxoid equals 8 µg pertussis toxoid equals 8 µg filamentous haemagglutinin equals 2.5 µg pertactin Adsorbed onto 0.5 mg aluminium as aluminium hydroxide and aluminium phosphate In this follow on study the aim was to compare surrogate measures of protection (IgG antibody) against pertussis prior to and following a DTPa or low dose dTap booster vaccine at 18 months old in children previously recruited in the primary birth pertussis vaccine study No additional booster vaccines were given in this study. Children enrolled on the study were given the routine immunization program at 12 months of age prior to enrolment in this study
Sponsors
The Sydney Children's Hospital Network
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
Children who are between 18 to 36 months old and were subjects previously enrolled in the First Phase study (ACTRN12609000905268) are eligible to participate in this study. Eligible children must meet inclusion and exclusion criteria at the time of first planned visit and parents/guardians must give written informed consent.
Exclusion criteria
Contraindications to vaccination as listed in the NHMRC Australian Immunisation Handbook or as listed in the Infanrix Product Information. DTPa or dTpa 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). Administration of immunoglobulins and any blood products within the 3 month period prior to the first visit or planned administration during the study period; in which case, a delay in enrolment will be considered in the absence of other excluding criteria. Any confirmed or suspected immunosuppressive or immunodeficient condition. History of serious chronic illness or condition which in the judgement of the clinical investigator would preclude study participation. History of neurologic disease or seizure Must not have had a DTPa or dTpa booster vaccine in the second year of life (prior to study enrolment)
Outcome results
None listed