Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000013662
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
18/07/2005
Date last updated
18/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does early whooping cough (pertussis) vaccination provide earlier antibody protection for infants?
Scientific title
Does early whooping cough (pertussis) vaccination provide earlier antibody protection for infants? A pilot study to determine the appropriate design for a trial of acellular pertussis vaccine given at birth?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pertussis infection 75 0
Condition category
Condition code
Reproductive Health and Childbirth 90 90 0 0
Complications of newborn
Infection 91 91 0 0
Other infectious diseases
Respiratory 92 92 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 - pertussis vaccination at birth and 1 month old followed by routine vaccination
Group 2 - pertussis vaccination at birth followed by routine vaccination
Intervention code [1] 12 0
Prevention
Comparator / control treatment
Control group - routine vaccination
Control group
Dose comparison

Outcomes
Primary outcome [1] 119 0
Pertussis antibody response
Timepoint [1] 119 0
Secondary outcome [1] 278 0
Incidence and severity of local and systemic adverse effects
Timepoint [1] 278 0

Eligibility
Key inclusion criteria
Healthy Newborns less than 5 days old and born after 37 weeks gestation
Minimum age
0 Days
Maximum age
5 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious chronic illness or immunodeficiency

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation into 3 groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 126 0
Charities/Societies/Foundations
Name [1] 126 0
Financial Markets Foundation for Children
Country [1] 126 0
Australia
Primary sponsor type
Government body
Name
National Centre for Immunisation Research and Surveillance
Address
Country
Australia
Secondary sponsor category [1] 92 0
Commercial sector/Industry
Name [1] 92 0
Glaxo Smith Kline Pharmaceuticals
Address [1] 92 0
Country [1] 92 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 882 0
The Children's Hospital at Westmead
Ethics committee address [1] 882 0
Ethics committee country [1] 882 0
Australia
Date submitted for ethics approval [1] 882 0
Approval date [1] 882 0
Ethics approval number [1] 882 0
Ethics committee name [2] 883 0
Sydney West Area Health Service
Ethics committee address [2] 883 0
Ethics committee country [2] 883 0
Australia
Date submitted for ethics approval [2] 883 0
Approval date [2] 883 0
Ethics approval number [2] 883 0

Summary
Brief summary
In this study the antibody response (immunity) to pertussis vaccination will be compared in 3 groups, those who have routine pertussis vaccination commmencing at 2 months old with those who have received pertussis vaccines at birth and 1 month old or only birth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36026 0
Address 36026 0
Country 36026 0
Phone 36026 0
Fax 36026 0
Email 36026 0
Contact person for public queries
Name 9201 0
Nicholas Wood
Address 9201 0
National Centre for Immunisation Research and Surveillance
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 9201 0
Australia
Phone 9201 0
+61 2 98451429
Fax 9201 0
+61 2 98451418
Email 9201 0
[email protected]
Contact person for scientific queries
Name 129 0
Nicholas Wood
Address 129 0
National Centre for Immunisation Research and Surveillance
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 129 0
Australia
Phone 129 0
+61 2 98451429
Fax 129 0
+61 2 98451418
Email 129 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.