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Link to original content: https://pubmed.ncbi.nlm.nih.gov/27091823
Safety of Tdap vaccine in pregnant women: an observational study - PubMed Skip to main page content
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. 2016 Apr 18;6(4):e010911.
doi: 10.1136/bmjopen-2015-010911.

Safety of Tdap vaccine in pregnant women: an observational study

Helen Petousis-Harris  1 , Tony Walls  2 , Donna Watson  1 , Janine Paynter  1 , Patricia Graham  3 , Nikki Turner  1
Affiliations

Safety of Tdap vaccine in pregnant women: an observational study

Helen Petousis-Harris et al. BMJ Open. .

Abstract

Objectives: Actively recruit and intensively follow pregnant women receiving a dose of acellular pertussis vaccine for 4 weeks after vaccination.

Design and settings: A prospective observational study conducted in 2 New Zealand regions.

Participants: Women in their 28th-38th week of pregnancy, recruited from primary care and antenatal clinics at the time of Tdap administration. Telephone interviews were conducted at 48 h and 4 weeks postvaccination.

Main outcomes measures: Outcomes were injection site reactions, systemic symptoms and serious adverse events (SAEs). Where available, data have been classified and reported according to Brighton Collaboration definitions.

Results: 793 women participated with 27.9% receiving trivalent inactivated influenza vaccine concomitantly. 79% of participants reported mild or moderate pain and 2.6% severe pain. Any swelling was reported by 7.6%, induration by 12.0% (collected from 1 site only, n=326), and erythema by 5.8% of participants. Fever was reported by 17 (2.1%) participants, 14 of these occurred within 24 h. Headache, dizziness, nausea, myalgia or arthralgia was reported by <4% of participants, respectively, and fatigue by 8.4%. During the study period, there were 115 adverse events in 113 participants, most of which were minor. At the end of the reporting period, 31 events were classified as serious (eg, obstetric bleeding, hypertension, infection, tachycardia, preterm labour, exacerbation of pre-existing condition and pre-eclampsia). All had variable onset time from vaccination. There were two perinatal deaths. Clinician assessment of all SAEs found none likely to be vaccine related.

Conclusions: Vaccination with Tdap in pregnant women was well tolerated with no SAE likely to be caused by the vaccine.

Trial registration number: ACTRN12613001045707.

Keywords: acellular pertussis vaccine; pregnancy; safety; vaccination; whooping cough.

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Figures

Figure 1
Figure 1
Participant recruitment and data collection.
Figure 2
Figure 2
Classification of maternal adverse events.
Figure 3
Figure 3
Classification of labour, delivery and infant-related adverse events.
Figure 4
Figure 4
Participant flow.
See this image and copyright information in PMC

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References

    1. Advisory Committee on Immunization Practices (ACIP). Summary Report February 23–24, 2011. Atlanta, Georgia, 2011.
    1. Davies SC. Temporary programme of pertussis (whooping cough) vaccination of pregnant women. 28 Sept 2012 Department of Health, London, 2012.
    1. Amirthalingam G, Andrews N, Campbell H et al. . Effectiveness of maternal pertussis vaccination in England: an observational study. Lancet 2014;384:1521–8. 10.1016/S0140-6736(14)60686-3 - DOI - PubMed
    1. Dabrera G, Amirthalingam G, Andrews N et al. . A case-control study to estimate the effectiveness of maternal pertussis vaccination in protecting newborn infants in England and Wales, 2012–2013. Clin Infect Dis 2015;60:333–7. 10.1093/cid/ciu821 - DOI - PubMed
    1. Englund JA. Maternal immunization—promises and concerns. Vaccine 2015;33:6372–3. 10.1016/j.vaccine.2015.07.084 - DOI - PubMed

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