'Links2HealthierBubs' cohort study: protocol for a record linkage study on the safety, uptake and effectiveness of influenza and pertussis vaccines among pregnant Australian women

Mohinder Sarna, Ross Andrews, Hannah Moore, Michael J. Binks, Lisa Mchugh, Gavin F. Pereira, Christopher C. Blyth, Paul Van Buynder, Karin Lust, Paul Effler, Stephen B. Lambert, Saad B. Omer, Donna B. Mak, Thomas Snelling, Heather A. D'antoine, Peter Mcintyre, Nicholas De Klerk, Damien Foo, Annette K. Regan

Research output: Contribution to journalArticle

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Abstract

Introduction Pregnant women and infants are at risk of severe influenza and pertussis infection. Inactivated influenza vaccine (IIV) and diphtheria-tetanus-acellular pertussis vaccine (dTpa) are recommended during pregnancy to protect both mothers and infants. In Australia, uptake is not routinely monitored but coverage appears sub-optimal. Evidence on the safety of combined antenatal IIV and dTpa is fragmented or deficient, and there remain knowledge gaps of population-level vaccine effectiveness. We aim to establish a large, population-based, multi-jurisdictional cohort of mother-infant pairs to measure the uptake, safety and effectiveness of antenatal IIV and dTpa vaccines in three Australian jurisdictions. This is a first step toward assessing the impact of antenatal vaccination programmes in Australia, which can then inform government policy with respect to future strategies in national vaccination programmes. Methods and analysis ' Links2HealthierBubs' is an observational, population-based, retrospective cohort study established through probabilistic record linkage of administrative health data. The cohort includes births between 2012 and 2017 (∼607 605 mother-infant pairs) in jurisdictions with population-level antenatal vaccination and health outcome data (Western Australia, Queensland and the Northern Territory). Perinatal data will be the reference frame to identify the cohort. Jurisdictional vaccination registers will identify antenatal vaccination status and the gestational timing of vaccination. Information on maternal, fetal and child health outcomes will be obtained from hospitalisation and emergency department records, notifiable diseases databases, developmental anomalies databases, birth and mortality registers. Ethics and dissemination Ethical approval was obtained from the Western Australian Department of Health, Curtin University, the Menzies School of Health Research, the Royal Brisbane and Women's Hospital, and the West Australian Aboriginal Health Ethics Committees. Research findings will be disseminated in peer-reviewed journals, at scientific meetings, and may be incorporated into communication materials for public health agencies and the public.

Original languageEnglish
Article numbere030277
JournalBMJ Open
Volume9
Issue number6
DOIs
Publication statusPublished - 1 Jun 2019

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Pertussis Vaccine
Influenza Vaccines
Pregnant Women
Vaccination
Cohort Studies
Diphtheria-Tetanus-acellular Pertussis Vaccines
Safety
Inactivated Vaccines
Mothers
Health
Population
Vaccines
Parturition
Northern Territory
Databases
Ethics Committees
Western Australia
Queensland
School Health Services
Whooping Cough

Cite this

Sarna, Mohinder ; Andrews, Ross ; Moore, Hannah ; Binks, Michael J. ; Mchugh, Lisa ; Pereira, Gavin F. ; Blyth, Christopher C. ; Van Buynder, Paul ; Lust, Karin ; Effler, Paul ; Lambert, Stephen B. ; Omer, Saad B. ; Mak, Donna B. ; Snelling, Thomas ; D'antoine, Heather A. ; Mcintyre, Peter ; De Klerk, Nicholas ; Foo, Damien ; Regan, Annette K. / 'Links2HealthierBubs' cohort study : protocol for a record linkage study on the safety, uptake and effectiveness of influenza and pertussis vaccines among pregnant Australian women. In: BMJ Open. 2019 ; Vol. 9, No. 6.
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abstract = "Introduction Pregnant women and infants are at risk of severe influenza and pertussis infection. Inactivated influenza vaccine (IIV) and diphtheria-tetanus-acellular pertussis vaccine (dTpa) are recommended during pregnancy to protect both mothers and infants. In Australia, uptake is not routinely monitored but coverage appears sub-optimal. Evidence on the safety of combined antenatal IIV and dTpa is fragmented or deficient, and there remain knowledge gaps of population-level vaccine effectiveness. We aim to establish a large, population-based, multi-jurisdictional cohort of mother-infant pairs to measure the uptake, safety and effectiveness of antenatal IIV and dTpa vaccines in three Australian jurisdictions. This is a first step toward assessing the impact of antenatal vaccination programmes in Australia, which can then inform government policy with respect to future strategies in national vaccination programmes. Methods and analysis ' Links2HealthierBubs' is an observational, population-based, retrospective cohort study established through probabilistic record linkage of administrative health data. The cohort includes births between 2012 and 2017 (∼607 605 mother-infant pairs) in jurisdictions with population-level antenatal vaccination and health outcome data (Western Australia, Queensland and the Northern Territory). Perinatal data will be the reference frame to identify the cohort. Jurisdictional vaccination registers will identify antenatal vaccination status and the gestational timing of vaccination. Information on maternal, fetal and child health outcomes will be obtained from hospitalisation and emergency department records, notifiable diseases databases, developmental anomalies databases, birth and mortality registers. Ethics and dissemination Ethical approval was obtained from the Western Australian Department of Health, Curtin University, the Menzies School of Health Research, the Royal Brisbane and Women's Hospital, and the West Australian Aboriginal Health Ethics Committees. Research findings will be disseminated in peer-reviewed journals, at scientific meetings, and may be incorporated into communication materials for public health agencies and the public.",
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author = "Mohinder Sarna and Ross Andrews and Hannah Moore and Binks, {Michael J.} and Lisa Mchugh and Pereira, {Gavin F.} and Blyth, {Christopher C.} and {Van Buynder}, Paul and Karin Lust and Paul Effler and Lambert, {Stephen B.} and Omer, {Saad B.} and Mak, {Donna B.} and Thomas Snelling and D'antoine, {Heather A.} and Peter Mcintyre and {De Klerk}, Nicholas and Damien Foo and Regan, {Annette K.}",
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Sarna, M, Andrews, R, Moore, H, Binks, MJ, Mchugh, L, Pereira, GF, Blyth, CC, Van Buynder, P, Lust, K, Effler, P, Lambert, SB, Omer, SB, Mak, DB, Snelling, T, D'antoine, HA, Mcintyre, P, De Klerk, N, Foo, D & Regan, AK 2019, ''Links2HealthierBubs' cohort study: protocol for a record linkage study on the safety, uptake and effectiveness of influenza and pertussis vaccines among pregnant Australian women' BMJ Open, vol. 9, no. 6, e030277. https://doi.org/10.1136/bmjopen-2019-030277

'Links2HealthierBubs' cohort study : protocol for a record linkage study on the safety, uptake and effectiveness of influenza and pertussis vaccines among pregnant Australian women. / Sarna, Mohinder; Andrews, Ross; Moore, Hannah; Binks, Michael J.; Mchugh, Lisa; Pereira, Gavin F.; Blyth, Christopher C.; Van Buynder, Paul; Lust, Karin; Effler, Paul; Lambert, Stephen B.; Omer, Saad B.; Mak, Donna B.; Snelling, Thomas; D'antoine, Heather A.; Mcintyre, Peter; De Klerk, Nicholas; Foo, Damien; Regan, Annette K.

In: BMJ Open, Vol. 9, No. 6, e030277, 01.06.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 'Links2HealthierBubs' cohort study

T2 - protocol for a record linkage study on the safety, uptake and effectiveness of influenza and pertussis vaccines among pregnant Australian women

AU - Sarna, Mohinder

AU - Andrews, Ross

AU - Moore, Hannah

AU - Binks, Michael J.

AU - Mchugh, Lisa

AU - Pereira, Gavin F.

AU - Blyth, Christopher C.

AU - Van Buynder, Paul

AU - Lust, Karin

AU - Effler, Paul

AU - Lambert, Stephen B.

AU - Omer, Saad B.

AU - Mak, Donna B.

AU - Snelling, Thomas

AU - D'antoine, Heather A.

AU - Mcintyre, Peter

AU - De Klerk, Nicholas

AU - Foo, Damien

AU - Regan, Annette K.

PY - 2019/6/1

Y1 - 2019/6/1

N2 - Introduction Pregnant women and infants are at risk of severe influenza and pertussis infection. Inactivated influenza vaccine (IIV) and diphtheria-tetanus-acellular pertussis vaccine (dTpa) are recommended during pregnancy to protect both mothers and infants. In Australia, uptake is not routinely monitored but coverage appears sub-optimal. Evidence on the safety of combined antenatal IIV and dTpa is fragmented or deficient, and there remain knowledge gaps of population-level vaccine effectiveness. We aim to establish a large, population-based, multi-jurisdictional cohort of mother-infant pairs to measure the uptake, safety and effectiveness of antenatal IIV and dTpa vaccines in three Australian jurisdictions. This is a first step toward assessing the impact of antenatal vaccination programmes in Australia, which can then inform government policy with respect to future strategies in national vaccination programmes. Methods and analysis ' Links2HealthierBubs' is an observational, population-based, retrospective cohort study established through probabilistic record linkage of administrative health data. The cohort includes births between 2012 and 2017 (∼607 605 mother-infant pairs) in jurisdictions with population-level antenatal vaccination and health outcome data (Western Australia, Queensland and the Northern Territory). Perinatal data will be the reference frame to identify the cohort. Jurisdictional vaccination registers will identify antenatal vaccination status and the gestational timing of vaccination. Information on maternal, fetal and child health outcomes will be obtained from hospitalisation and emergency department records, notifiable diseases databases, developmental anomalies databases, birth and mortality registers. Ethics and dissemination Ethical approval was obtained from the Western Australian Department of Health, Curtin University, the Menzies School of Health Research, the Royal Brisbane and Women's Hospital, and the West Australian Aboriginal Health Ethics Committees. Research findings will be disseminated in peer-reviewed journals, at scientific meetings, and may be incorporated into communication materials for public health agencies and the public.

AB - Introduction Pregnant women and infants are at risk of severe influenza and pertussis infection. Inactivated influenza vaccine (IIV) and diphtheria-tetanus-acellular pertussis vaccine (dTpa) are recommended during pregnancy to protect both mothers and infants. In Australia, uptake is not routinely monitored but coverage appears sub-optimal. Evidence on the safety of combined antenatal IIV and dTpa is fragmented or deficient, and there remain knowledge gaps of population-level vaccine effectiveness. We aim to establish a large, population-based, multi-jurisdictional cohort of mother-infant pairs to measure the uptake, safety and effectiveness of antenatal IIV and dTpa vaccines in three Australian jurisdictions. This is a first step toward assessing the impact of antenatal vaccination programmes in Australia, which can then inform government policy with respect to future strategies in national vaccination programmes. Methods and analysis ' Links2HealthierBubs' is an observational, population-based, retrospective cohort study established through probabilistic record linkage of administrative health data. The cohort includes births between 2012 and 2017 (∼607 605 mother-infant pairs) in jurisdictions with population-level antenatal vaccination and health outcome data (Western Australia, Queensland and the Northern Territory). Perinatal data will be the reference frame to identify the cohort. Jurisdictional vaccination registers will identify antenatal vaccination status and the gestational timing of vaccination. Information on maternal, fetal and child health outcomes will be obtained from hospitalisation and emergency department records, notifiable diseases databases, developmental anomalies databases, birth and mortality registers. Ethics and dissemination Ethical approval was obtained from the Western Australian Department of Health, Curtin University, the Menzies School of Health Research, the Royal Brisbane and Women's Hospital, and the West Australian Aboriginal Health Ethics Committees. Research findings will be disseminated in peer-reviewed journals, at scientific meetings, and may be incorporated into communication materials for public health agencies and the public.

KW - antenatal

KW - immunisation

KW - vaccine

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U2 - 10.1136/bmjopen-2019-030277

DO - 10.1136/bmjopen-2019-030277

M3 - Article

VL - 9

JO - BMJ (Open)

JF - BMJ (Open)

SN - 2044-6055

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