Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001453471
Ethics application status
Approved
Date submitted
13/10/2016
Date registered
18/10/2016
Date last updated
22/06/2020
Date data sharing statement initially provided
11/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Funded pharmacy vaccination of pregnant women: uptake and views and experiences
Scientific title
Funded pharmacist-delivered pertussis and influenza vaccination of pregnant women. The effect on vaccine uptake and views and experiences of women and health professionals
Secondary ID [1] 290312 0
Nil known
Universal Trial Number (UTN)
U1111-1188-6022
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccination 300570 0
Pertussis 300571 0
Influenza 300572 0
Pregnancy 300573 0
Condition category
Condition code
Infection 300427 300427 0 0
Other infectious diseases
Public Health 300428 300428 0 0
Health service research
Reproductive Health and Childbirth 300457 300457 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Influenza vaccine was funded in pregnancy in pharmacy nationally, ie in all areas as from 1 April 2017. and Waikato started from Nov 2016 funding pertussis. This will now be called an observational study.
Drugs and dose: Combined diphtheria-tetanus-acellular pertussis vaccine (funded for a single delivery between week 28 and week 38 of pregnancy) and influenza vaccine (funded for a single delivery at any stage of pregnancy), both vaccines will be delivered by intra-muscular injection. The period observed will be 24 months.
Any pregnant woman in the Waikato will be able to present to a pharmacy (or traditional areas ie general practice or hospitals) for the funded vaccinations.
Intervention code [1] 296125 0
Prevention
Comparator / control treatment
Funding of influenza vaccine in pregnancy in pharmacy started nationwide from 1 April 2017. Pertussis vaccine in pregnancy is not currently funded in pharmacy except in the Waikato area hence the observation. Control areas for whooping cough are Hawkes Bay and Northland district health boards.
Control group
Active

Outcomes
Primary outcome [1] 299868 0
Number of influenza vaccinations in pregnant women both overall and by delivery location (general practice, hospital, pharmacy). Measured through vaccination data collected in National Immunisation Record and claims data
Timepoint [1] 299868 0
24 months after 1 Nov 2016
Primary outcome [2] 299894 0
Number of pertussis vaccinations in pregnant women both overall and by delivery location (general practice, hospital, pharmacy). Measured through vaccination data collected in National Immunisation Record and claims data
Timepoint [2] 299894 0
24 months after 1 Nov 2016
Primary outcome [3] 324208 0
Number of influenza and pertussis vaccinations in pregnant women both overall and by delivery location (general practice, hospital, pharmacy). Measured through vaccination data collected in National Immunisation Record and claims data over a 3-3.5 year period
Timepoint [3] 324208 0
3-3.5 years after the intervention started
Secondary outcome [1] 328342 0
Number of influenza vaccinations in pregnant women who are of Maori ethnicity, and/or in high deprivation areas, both overall and by delivery location. Measured through vaccination data collected in National Immunisation Record and claims data
Timepoint [1] 328342 0
Measured at 24 months after starting funding, and again at 3-3.5 years after starting funding
Secondary outcome [2] 328409 0
Number of pertussis vaccinations (Tdap) in pregnant women who are of Maori ethnicity, and/or in high deprivation areas, both overall and by delivery location. Measured through vaccination data collected in National Immunisation Record and claims data
Timepoint [2] 328409 0
Measured at 24 months after starting funding, and again at 3-3.5 years after starting funding
Secondary outcome [3] 328410 0
To ascertain the views and experiences of women eligible for the vaccination during pregnancy (some who used the intervention and some who did not) regarding the intervention using semi-structured qualitative interviews. Note: these women will be invited to participate in the study and only with informed consent will the interview occur.
Timepoint [3] 328410 0
Approximately 18 months after funding started in Waikato in pharmacy
Secondary outcome [4] 328460 0
To ascertain the views and experiences of health professionals regarding the intervention using semi-structured qualitative interviews
Timepoint [4] 328460 0
Approximately 18 months after the Waikato started funding in pharmacy

Eligibility
Key inclusion criteria
Women who were pregnant during the observed period, are NZ residents, were eligible for the vaccinations during the study period, and have a surviving fetus beyond 27 weeks.
Note: women will not be enrolled as such for the primary outcome, and data will only be used for women who had the vaccinations and had a surviving fetus beyond 27 weeks. Women will be eligible for the vaccinations if pregnant but if they do not have a surviving fetus beyond 27 weeks will not be included.
For the secondary qualitative research, women will be invited to participate in an interview and only with informed consent will the interview progress.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who deliver before 27 weeks, or who do not deliver a live baby. Women who are not eligible for funded vaccines (e.g. not NZ residents).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2016
Actual
13/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
27000
Accrual to date
20000
Final
Recruitment outside Australia
Country [1] 8309 0
New Zealand
State/province [1] 8309 0

Funding & Sponsors
Funding source category [1] 294695 0
Government body
Name [1] 294695 0
Waikato District Health Board
Country [1] 294695 0
New Zealand
Funding source category [2] 299232 0
Commercial sector/Industry
Name [2] 299232 0
GlaxoSmithKline
Country [2] 299232 0
New Zealand
Primary sponsor type
Individual
Name
Dr Natalie Gauld
Address
Dept of General Practice and Primary Health Care
Faculty of Medical and Health Sciences
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293542 0
Individual
Name [1] 293542 0
Professor Cameron Grant
Address [1] 293542 0
Dept of Paediatrics
The University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 293542 0
New Zealand
Secondary sponsor category [2] 293543 0
Individual
Name [2] 293543 0
Dr Helen Petousis Harris
Address [2] 293543 0
Immunisation Advisory Centre
Dept of General Practice and Primary Health care
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142
Country [2] 293543 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296117 0
Northern B
Ethics committee address [1] 296117 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 296117 0
New Zealand
Date submitted for ethics approval [1] 296117 0
01/02/2018
Approval date [1] 296117 0
20/03/2018
Ethics approval number [1] 296117 0

Summary
Brief summary
Low uptake of influenza vaccine and pertussis vaccine in pregnancy in New Zealand needs to be addressed. The hypothesis we seek to test is that providing funded pertussis and influenza vaccinations in pregnancy through community pharmacy will increase uptake in pregnant women, including those living in areas of higher household deprivation, and in women of Maori ethnicity.
In one area of NZ (intervention area) these vaccinations will be funded through community pharmacies as well as the traditional areas (general practice and hospitals). In geographically comparable areas (controls) funding remains standard (general practice and hospital).
The study will measure uptake overall and by location of vaccine delivery in women, and a further analysis will examine uptake in Maori and high deprivation populations,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69626 0
Dr Natalie Gauld
Address 69626 0
Department of General Practice and Primary Health CAre
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142
Country 69626 0
New Zealand
Phone 69626 0
+6421336685
Fax 69626 0
Email 69626 0
[email protected]
Contact person for public queries
Name 69627 0
Dr Natalie Gauld
Address 69627 0
Department of General Practice and Primary Health CAre
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142
Country 69627 0
New Zealand
Phone 69627 0
+6421336685
Fax 69627 0
Email 69627 0
[email protected]
Contact person for scientific queries
Name 69628 0
Dr Natalie Gauld
Address 69628 0
Department of General Practice and Primary Health CAre
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142
Country 69628 0
New Zealand
Phone 69628 0
+6421336685
Fax 69628 0
Email 69628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage I do not know if it will be available. This uses Ministry of Health information and we would need their permission.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3821Basic resultsNo 371642-(Uploaded-25-01-2022-20-15-16)-Basic results summary.docx
4032Plain language summaryNo Extending availability of pertussis vaccination to... [More Details]
4628Study results articleYes Gauld, N., S. Martin, O. Sinclair, H. Petousis-Har... [More Details] 371642-(Uploaded-25-01-2022-20-02-09)-Journal results publication.pdf
4629Study results articleYes Gauld, N.; Martin, S.; Sinclair, O.; Petousis-Harr... [More Details] 371642-(Uploaded-19-01-2022-20-26-41)-Journal results publication.pdf
4630Study results articleYes Gauld N, Martin S, Sinclair O, Dumble F, Petousis-... [More Details]
4631Study results articleYes Howe AS, Gauld NJ, Cavadino AY, Petousis-Harris H,... [More Details]
4632Study results articleYes Gauld N, Martin S, Sinclair O, Petousis-Harris H, ... [More Details]

Documents added automatically
No additional documents have been identified.