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Trial registered on ANZCTR


Registration number
ACTRN12609000905268
Ethics application status
Approved
Date submitted
16/10/2009
Date registered
19/10/2009
Date last updated
19/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Immunogenicity and safety of acellular pertussis (whooping cough) vaccine at birth
Scientific title
Immunogenicity and safety of acellular pertussis vaccine given at birth in healthy infants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
whooping cough (pertussis) 252003 0
Condition category
Condition code
Infection 252211 252211 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241414 0
Prevention
Comparator / control treatment
Mothers who have not had any whooping cough booster vaccine within the last 5 years/ or never have had the vaccine 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 (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
Control group
Active

Outcomes
Primary outcome [1] 253076 0
Efficacy.
Immunoglobulin G (IgG) to pertussis toxin (PT), pertactin and filamentous hemagglutinin (FHA) will be measured by enzyme-linked immunosorbent assay (ELISA) in maternal and infant serum samples at GSK Biologicals, Belgium, using a well-standardised assay.
Timepoint [1] 253076 0
at 6 weeks, 10 weeks, 6 and 8 months of age Blood samples will be taken as follows: maternal blood at birth, infant blood at 6 weeks, 10 weeks, 6 and 8 months.
Secondary outcome [1] 257921 0
Safety
a 7 day diary card will be given to parents to record any reaction include: fever (axillary temperature > 38oC ), drowsiness (unusually sleepy or inactive), fussiness scored as normal, periodically more irritable than usual but with normal activity [mild], prolonged crying and refused to play [moderate], prolonged crying and unable to be comforted [severe], anorexia defined as unusually poor appetite, vomiting judged to be greater than a posset, redness and swelling at the vaccination site each measured in mm, pain scored as none, minor light reaction to touch [mild], crying or protesting to touch [moderate], or crying when the leg is moved [severe]).
Timepoint [1] 257921 0
7 day diary card. Parents will be asked to record reactions 3 & 6 hours after injection, at bedtime each evening for 7 evenings.

Eligibility
Key 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.
Minimum age
1 Hours
Maximum age
5 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised but not blinded.
Randomisation will use the central randomisation service at the National Health and Medical Research Council (NMHRC) Clinical Trial Centre, Sydney, by automated interactive voice response system (available 24hrs)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification: This will be by maternal immunisation status in 2 groups:
Group 1 - tetanus, diphtheria and pertussis vaccine(dTpa) within last 5 years
Group 2 – no previous dTpa vaccine or dTpa vaccine > 5 years pre pregnancy.

Randomisation: Neonates will be randomly assigned to one of two groups:
1. Birth group (early vaccination) Pa vaccine at birth, 6 weeks, 4 months and 6 months.
2. Control group (standard vaccination) usual vaccinations at 6 weeks, 4 months and 6 months.

Simple randomisation by using a randomisation table created by a computer software will used.
we will use the central randomisation service at the NMHRC Clinical Trial Centre, Sydney, by automated interactive voice response system (available 24hrs)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243882 0
Government body
Name [1] 243882 0
National Health and Medical Research Council (NHMRC)
Country [1] 243882 0
Australia
Primary sponsor type
Individual
Name
Peter McIntyre
Address
National Centre for Immunisation Research and Surveillance (NCIRS)
Locked Bag 4001
WESTMEAD NSW 2145
Country
Australia
Secondary sponsor category [1] 251230 0
Individual
Name [1] 251230 0
Terry Nolan
Address [1] 251230 0
Royal Children's Hospital and University of Melbourne.
Flemington Road, Parkville Vic. 3052
Country [1] 251230 0
Australia
Secondary sponsor category [2] 251231 0
Individual
Name [2] 251231 0
Helen Marshall
Address [2] 251231 0
79 King William Rd. Adelaide, SA 5006
Country [2] 251231 0
Australia
Secondary sponsor category [3] 251232 0
Individual
Name [3] 251232 0
Peter Richmond
Address [3] 251232 0
Princess Margaret Hospital for Children.
Roberts Road, Subiaco, Perth, WA 6008
Country [3] 251232 0
Australia
Other collaborator category [1] 907 0
Hospital
Name [1] 907 0
Royal Children's Hospital of Melbourne
Address [1] 907 0
Royal Children's Hospital of Melbourne.
Flemington Road, Parkville Vic. 3052
Country [1] 907 0
Australia
Other collaborator category [2] 908 0
Hospital
Name [2] 908 0
Women's and Children's Hospital
Address [2] 908 0
79 King William Rd
Adelaide, SA 5006
Country [2] 908 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244002 0
Royal Alexandra Hospital for Children Human Research Ethics Committee (HREC)
Ethics committee address [1] 244002 0
Ethics committee country [1] 244002 0
Australia
Date submitted for ethics approval [1] 244002 0
11/05/2009
Approval date [1] 244002 0
Ethics approval number [1] 244002 0
09/CHW/6

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30388 0
Address 30388 0
Country 30388 0
Phone 30388 0
Fax 30388 0
Email 30388 0
Contact person for public queries
Name 13635 0
Nicholas Wood
Address 13635 0
The Children’s Hospital at Westmead
NCIRS Locked Bag 4001 Westmead NSW 2145
Country 13635 0
Australia
Phone 13635 0
(61 2) 9845 1433
Fax 13635 0
(61 2) 9845 1418
Email 13635 0
[email protected]
Contact person for scientific queries
Name 4563 0
Nicholas Wood
Address 4563 0
The Children’s Hospital at Westmead
NCIRS Locked Bag 4001 Westmead NSW 2145
Country 4563 0
Australia
Phone 4563 0
(61 2) 9845 1433
Fax 4563 0
(61 2) 9845 1418
Email 4563 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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