The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian mother-infant pairs, 2012-2015

The FluMum study

Lisa Mchugh, Helen S. Marshall, Kirsten P. Perrett, Terry Nolan, Nicholas Wood, Stephen B Lambert, Peter Richmond, Robert S. Ware, Paula Binks, Michael Binks, Ross Andrews

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Background: Inactivated influenza vaccine (IIV) and pertussis vaccination are recommended in pregnancy. Limited safety data exist for women who received IIV vaccine during the first trimester of pregnancy or received both vaccines in pregnancy. We assessed adverse birth outcomes between vaccinated and unvaccinated pregnancies.


    Methods: Among prospectively enrolled Australian “FluMum” participants (2012–2015), primary exposure was receipt and timing of IIV during pregnancy. Primary outcomes included preterm birth, low birthweight at term (LBWT), and small for gestational age (SGA). We compared birth outcomes for IIV in pregnancy with women unvaccinated in pregnancy using Cox proportional hazard ratios (HRs) with 95% confidence intervals (CIs). Adjusted HRs (aHRs) controlled for potential confounding variables. Sensitivity analyses were conducted in a subgroup of women who received pertussis vaccination during pregnancy to assess whether associations between IIV and adverse outcomes were maintained after adjusting for pertussis vaccination.


    Results: Among 8827 participants in our study, women who received IIV in pregnancy did not have an elevated risk of an adverse birth outcome compared with unvaccinated pregnant women: preterm births (HR, 1.10 [95% CI, .92–1.31]; P = .28); LBWT (HR, 1.05 [95% CI, .76–1.44]; P = .77); or SGA (HR, 0.99 [95% CI, .86–1.15]; P = .94). Adjustment for pertussis vaccination during pregnancy yielded similar results: preterm births (aHR, 1.05 [95% CI, .82–1.34]; P = .69); LBWT (aHR, 0.81 [95% CI, .50–1.29]; P = .37); SGA (aHR, 0.92 [95% CI, .74–1.14]; P = .43). There was no evidence of elevated risk by trimester of IIV.


    Conclusions: No significant associations were found between maternal IIV or pertussis vaccination in pregnancy and adverse birth outcomes, regardless of the trimester of pregnancy a vaccination was given compared to unvaccinated pregnancies.

    Original languageEnglish
    Article numberciy517
    Pages (from-to)402-408
    Number of pages7
    JournalOxford Journal
    Volume68
    Issue number3
    Early online date23 Nov 2018
    DOIs
    Publication statusPublished - 1 Feb 2019

    Fingerprint

    Whooping Cough
    Human Influenza
    Vaccination
    Mothers
    Inactivated Vaccines
    Safety
    Influenza Vaccines
    Pregnancy
    Confidence Intervals
    Premature Birth
    Parturition
    Pregnancy Trimesters
    Confounding Factors (Epidemiology)
    First Pregnancy Trimester
    Gestational Age
    Pregnant Women
    Vaccines

    Cite this

    Mchugh, Lisa ; Marshall, Helen S. ; Perrett, Kirsten P. ; Nolan, Terry ; Wood, Nicholas ; Lambert, Stephen B ; Richmond, Peter ; Ware, Robert S. ; Binks, Paula ; Binks, Michael ; Andrews, Ross. / The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian mother-infant pairs, 2012-2015 : The FluMum study. In: Oxford Journal. 2019 ; Vol. 68, No. 3. pp. 402-408.
    @article{92b7772e6bd14f069db2b69c310f67a9,
    title = "The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian mother-infant pairs, 2012-2015: The FluMum study",
    abstract = "Background: Inactivated influenza vaccine (IIV) and pertussis vaccination are recommended in pregnancy. Limited safety data exist for women who received IIV vaccine during the first trimester of pregnancy or received both vaccines in pregnancy. We assessed adverse birth outcomes between vaccinated and unvaccinated pregnancies. Methods: Among prospectively enrolled Australian “FluMum” participants (2012–2015), primary exposure was receipt and timing of IIV during pregnancy. Primary outcomes included preterm birth, low birthweight at term (LBWT), and small for gestational age (SGA). We compared birth outcomes for IIV in pregnancy with women unvaccinated in pregnancy using Cox proportional hazard ratios (HRs) with 95{\%} confidence intervals (CIs). Adjusted HRs (aHRs) controlled for potential confounding variables. Sensitivity analyses were conducted in a subgroup of women who received pertussis vaccination during pregnancy to assess whether associations between IIV and adverse outcomes were maintained after adjusting for pertussis vaccination. Results: Among 8827 participants in our study, women who received IIV in pregnancy did not have an elevated risk of an adverse birth outcome compared with unvaccinated pregnant women: preterm births (HR, 1.10 [95{\%} CI, .92–1.31]; P = .28); LBWT (HR, 1.05 [95{\%} CI, .76–1.44]; P = .77); or SGA (HR, 0.99 [95{\%} CI, .86–1.15]; P = .94). Adjustment for pertussis vaccination during pregnancy yielded similar results: preterm births (aHR, 1.05 [95{\%} CI, .82–1.34]; P = .69); LBWT (aHR, 0.81 [95{\%} CI, .50–1.29]; P = .37); SGA (aHR, 0.92 [95{\%} CI, .74–1.14]; P = .43). There was no evidence of elevated risk by trimester of IIV. Conclusions: No significant associations were found between maternal IIV or pertussis vaccination in pregnancy and adverse birth outcomes, regardless of the trimester of pregnancy a vaccination was given compared to unvaccinated pregnancies.",
    author = "Lisa Mchugh and Marshall, {Helen S.} and Perrett, {Kirsten P.} and Terry Nolan and Nicholas Wood and Lambert, {Stephen B} and Peter Richmond and Ware, {Robert S.} and Paula Binks and Michael Binks and Ross Andrews",
    year = "2019",
    month = "2",
    day = "1",
    doi = "10.1093/cid/ciy517",
    language = "English",
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    Mchugh, L, Marshall, HS, Perrett, KP, Nolan, T, Wood, N, Lambert, SB, Richmond, P, Ware, RS, Binks, P, Binks, M & Andrews, R 2019, 'The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian mother-infant pairs, 2012-2015: The FluMum study', Oxford Journal, vol. 68, no. 3, ciy517, pp. 402-408. https://doi.org/10.1093/cid/ciy517

    The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian mother-infant pairs, 2012-2015 : The FluMum study. / Mchugh, Lisa; Marshall, Helen S.; Perrett, Kirsten P.; Nolan, Terry; Wood, Nicholas; Lambert, Stephen B; Richmond, Peter; Ware, Robert S.; Binks, Paula; Binks, Michael; Andrews, Ross.

    In: Oxford Journal, Vol. 68, No. 3, ciy517, 01.02.2019, p. 402-408.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - The safety of influenza and pertussis vaccination in pregnancy in a cohort of Australian mother-infant pairs, 2012-2015

    T2 - The FluMum study

    AU - Mchugh, Lisa

    AU - Marshall, Helen S.

    AU - Perrett, Kirsten P.

    AU - Nolan, Terry

    AU - Wood, Nicholas

    AU - Lambert, Stephen B

    AU - Richmond, Peter

    AU - Ware, Robert S.

    AU - Binks, Paula

    AU - Binks, Michael

    AU - Andrews, Ross

    PY - 2019/2/1

    Y1 - 2019/2/1

    N2 - Background: Inactivated influenza vaccine (IIV) and pertussis vaccination are recommended in pregnancy. Limited safety data exist for women who received IIV vaccine during the first trimester of pregnancy or received both vaccines in pregnancy. We assessed adverse birth outcomes between vaccinated and unvaccinated pregnancies. Methods: Among prospectively enrolled Australian “FluMum” participants (2012–2015), primary exposure was receipt and timing of IIV during pregnancy. Primary outcomes included preterm birth, low birthweight at term (LBWT), and small for gestational age (SGA). We compared birth outcomes for IIV in pregnancy with women unvaccinated in pregnancy using Cox proportional hazard ratios (HRs) with 95% confidence intervals (CIs). Adjusted HRs (aHRs) controlled for potential confounding variables. Sensitivity analyses were conducted in a subgroup of women who received pertussis vaccination during pregnancy to assess whether associations between IIV and adverse outcomes were maintained after adjusting for pertussis vaccination. Results: Among 8827 participants in our study, women who received IIV in pregnancy did not have an elevated risk of an adverse birth outcome compared with unvaccinated pregnant women: preterm births (HR, 1.10 [95% CI, .92–1.31]; P = .28); LBWT (HR, 1.05 [95% CI, .76–1.44]; P = .77); or SGA (HR, 0.99 [95% CI, .86–1.15]; P = .94). Adjustment for pertussis vaccination during pregnancy yielded similar results: preterm births (aHR, 1.05 [95% CI, .82–1.34]; P = .69); LBWT (aHR, 0.81 [95% CI, .50–1.29]; P = .37); SGA (aHR, 0.92 [95% CI, .74–1.14]; P = .43). There was no evidence of elevated risk by trimester of IIV. Conclusions: No significant associations were found between maternal IIV or pertussis vaccination in pregnancy and adverse birth outcomes, regardless of the trimester of pregnancy a vaccination was given compared to unvaccinated pregnancies.

    AB - Background: Inactivated influenza vaccine (IIV) and pertussis vaccination are recommended in pregnancy. Limited safety data exist for women who received IIV vaccine during the first trimester of pregnancy or received both vaccines in pregnancy. We assessed adverse birth outcomes between vaccinated and unvaccinated pregnancies. Methods: Among prospectively enrolled Australian “FluMum” participants (2012–2015), primary exposure was receipt and timing of IIV during pregnancy. Primary outcomes included preterm birth, low birthweight at term (LBWT), and small for gestational age (SGA). We compared birth outcomes for IIV in pregnancy with women unvaccinated in pregnancy using Cox proportional hazard ratios (HRs) with 95% confidence intervals (CIs). Adjusted HRs (aHRs) controlled for potential confounding variables. Sensitivity analyses were conducted in a subgroup of women who received pertussis vaccination during pregnancy to assess whether associations between IIV and adverse outcomes were maintained after adjusting for pertussis vaccination. Results: Among 8827 participants in our study, women who received IIV in pregnancy did not have an elevated risk of an adverse birth outcome compared with unvaccinated pregnant women: preterm births (HR, 1.10 [95% CI, .92–1.31]; P = .28); LBWT (HR, 1.05 [95% CI, .76–1.44]; P = .77); or SGA (HR, 0.99 [95% CI, .86–1.15]; P = .94). Adjustment for pertussis vaccination during pregnancy yielded similar results: preterm births (aHR, 1.05 [95% CI, .82–1.34]; P = .69); LBWT (aHR, 0.81 [95% CI, .50–1.29]; P = .37); SGA (aHR, 0.92 [95% CI, .74–1.14]; P = .43). There was no evidence of elevated risk by trimester of IIV. Conclusions: No significant associations were found between maternal IIV or pertussis vaccination in pregnancy and adverse birth outcomes, regardless of the trimester of pregnancy a vaccination was given compared to unvaccinated pregnancies.

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    U2 - 10.1093/cid/ciy517

    DO - 10.1093/cid/ciy517

    M3 - Article

    VL - 68

    SP - 402

    EP - 408

    JO - Oxford Journal

    JF - Oxford Journal

    SN - 1551-4498

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    M1 - ciy517

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