None listed
Conditions
Brief summary
This study is the third phase follow up at 4 years of age of subjects who received neonatal acellular pertussis vaccination. This study looks at safety and immunogenicity of pertussis vaccination, and extends knowledge from the first phase (birth to 13 months) and the second phase (18-24 months).
Interventions
All study participants in the intervention group will be vaccinated with acellular pertussis vaccine at 4 years of age. The intervention group refers to the study allocation from phase I of the study (already occurred), that is, those subjects who received a birth dose of monovalent acellular pertussis vaccine.
The intervention subgroup who received a booster dose of Infanrix-IPV (Registered trademark) (DTPa-IPV) at 18 months will receive the same Infanrix-IPV (Registered trademark) (DTPa-IP
All study participants in the intervention group will be vaccinated with acellular pertussis vaccine at 4 years of age. The intervention group refers to the study allocation from phase I of the study (already occurred), that is, those subjects who received a birth dose of monovalent acellular pertussis vaccine. The intervention subgroup who received a booster dose of Infanrix-IPV (Registered trademark) (DTPa-IPV) at 18 months will receive the same Infanrix-IPV (Registered trademark) (DTPa-IPV) for the 4 year old booster dose. The intervention subgroup who received Boostrix-IPV (Registered trademark) (dTpa-IPV) at 18 months will receive the same Boostrix-IPV (Registered trademark) (dTpa-IPV) for the 4 year old booster dose. The intervention subgroup who did not receive any booster dose at 18 months old, will receive Infanrix-IPV (Registered trademark) (DTPa-IPV) for the 4 year old booster dose. All participants in the intervention group will also be vaccinated at 4 years old with the measles-mumps-rubella vaccine (M-M-R-II), which is due according to the Australian Immunisation Schedule, but is not the study intervention. Vaccine product information: 1. Infanrix-IPV (Registered trademark) (DTPa-IPV) will be administered, by intramuscular injection. Infanrix-IPV (diphtheria-tetanus-acellular pertussis-inactivated poliovirus). Each 0.5 ml dose contains 30 IU diphtheria toxoid, 40 IU tetanus toxoid, 25 ug pertussis toxoid, 25 ug filamentous haemagglutinin, 8 ug pertactin, 40 D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen units type 3 (Saukett), adsorbed onto aluminium hydroxide; traces of formaldehyde, polysorbate 80, polymyxin and neomycin. 2. Boostrix-IPV (Registered trademark) (dTpa-IPV) will be administered, by intramuscular injection. Boostrix-IPV (diphtheria-tetanus-acellular pertussis-inactivated poliovirus). Each 0.5 ml dose contains 2 IU diphtheria toxoid, 20 IU tetanus toxoid, 8 ug pertussis toxoid, 8 ug filamentous haemagglutinin, 2.5 ug pertactin, 40 D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen units type 3 (Saukett), adsorbed onto aluminium hydroxide and aluminium phosphate; traces of formaldehyde, polysorbate 80, polymyxin and neomycin. 3. M-M-R II (live attenuated measles virus [Schwarz strainEnders’ attenuated Edmonston strain], mumps virus [RIT 4385 strain, derived from the Jeryl Lynn B level strain] and rubella virus [Wistar RA 27/3 strain]) will be administered by intramuscular injection. Lyophilised pellet in a monodose vial with separate diluenta pre-filled diluent syringe. Each 0.5 ml reconstituted dose contains 10003.0 tissuecell culture infectious dose 50% (TCCID50) of the Schwarz Enders’ attenuated Edmonston measles virus, 12 50003.7 TCCID50 of the RIT 4385Jeryl Lynn B level mumps virus, and 10003.0 TCCID50 of the Wistar RA 27/3 rubella virus; lactose; neomycin; sorbitol; sucrose; hydrolysed gelatin; human albumin; fetal bovine serum; neomycinmannitol.
Sponsors
The Sydney Children's Hospitals Network
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
Children who are between 4 years and 4 years 364 days old are eligible to participate in this study and who are subjects previously enrolled in the First Phase study. (ACTRN12609000905268)
Exclusion criteria
1. Contraindications to vaccination as listed in the current NHMRC Australian Immunisation Handbook 10th Edition or as listed in the Infanrix-IPV or Boostrix-IPV Product Information. DTPa-IPV or dTpa-IPV 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). 2. Evidence of a second booster diphtheria, tetanus, pertussis vaccination since completion of the first booster vaccine at 18- 24 months old. 3. Administration of immunoglobulins or any blood products within the 3 month period prior to the first visit; in which case, a delay in enrolment will be considered in the absence of other excluding criteria. 4. Any confirmed or suspected immunosuppressive or immunodeficient condition contraindicating MMR vaccination. 5. History of serious chronic illness or condition which in the judgement of the clinical investigator would preclude study participation. 6. History of neurologic disease or seizure (excluding simple febrile seizure). 7. Must not have had the vaccinations scheduled for age 4 years (ie Infanrix-IPV and measles mumps rubella vaccine).
Outcome results
None listed