ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

U1111-1188-6022

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vaccination

Pertussis

Influenza

Pregnancy

Condition category

Condition code

Infection

Other infectious diseases

Public Health

Health service research

Reproductive Health and Childbirth

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]

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]

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]

24 months after 1 Nov 2016

Primary outcome [2]

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]

24 months after 1 Nov 2016

Primary outcome [3]

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]

3-3.5 years after the intervention started

Secondary outcome [1]

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]

Measured at 24 months after starting funding, and again at 3-3.5 years after starting funding

Secondary outcome [2]

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]

Measured at 24 months after starting funding, and again at 3-3.5 years after starting funding

Secondary outcome [3]

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]

Approximately 18 months after funding started in Waikato in pharmacy

Secondary outcome [4]

To ascertain the views and experiences of health professionals regarding the intervention using semi-structured qualitative interviews

Timepoint [4]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Waikato District Health Board

Address [1]

Population Health
Waikato District Health Board
Hugh Monckton Trust Building – L5
Cnr. Rostrevor & Harwood Streets
Private Bag 3200
Hamilton 3240

Country [1]

New Zealand

Funding source category [2]

Commercial sector/Industry

Name [2]

GlaxoSmithKline

Address [2]

Level 11, Zurich House, 21 Queen Street, Auckland 1010, NZ

Country [2]

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]

Individual

Name [1]

Professor Cameron Grant

Address [1]

Dept of Paediatrics
The University of Auckland
Private Bag 92019
Auckland 1142

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Dr Helen Petousis Harris

Address [2]

Immunisation Advisory Centre
Dept of General Practice and Primary Health care
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/02/2018

Approval date [1]

20/03/2018

Ethics approval number [1]

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

Dr Natalie Gauld

Address

Department of General Practice and Primary Health CAre
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6421336685

Fax

n.gauld@auckland.ac.nz

Contact person for public queries

Name

Natalie Gauld

Address

Department of General Practice and Primary Health CAre
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6421336685

Fax

n.gauld@auckland.ac.nz

Contact person for scientific queries

Name

Natalie Gauld

Address

Department of General Practice and Primary Health CAre
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6421336685

Fax

n.gauld@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Basic results	No		371642-(Uploaded-25-01-2022-20-15-16)-Basic results summary.docx
Plain language summary	No	Extending availability of pertussis vaccination to... [More Details]
Study results article	Yes	Gauld, N., S. Martin, O. Sinclair, H. Petousis-Har... [More Details]	371642-(Uploaded-25-01-2022-20-02-09)-Journal results publication.pdf
Study results article	Yes	Gauld, N.; Martin, S.; Sinclair, O.; Petousis-Harr... [More Details]	371642-(Uploaded-19-01-2022-20-26-41)-Journal results publication.pdf
Study results article	Yes	Gauld N, Martin S, Sinclair O, Dumble F, Petousis-... [More Details]
Study results article	Yes	Howe AS, Gauld NJ, Cavadino AY, Petousis-Harris H,... [More Details]
Study results article	Yes	Gauld N, Martin S, Sinclair O, Petousis-Harris H, ... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

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Documents added manually

Documents added automatically