Observational studyBMJ open2016
Safety of Tdap vaccine in pregnant women: an observational study.
Observational study in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- Pertussis resurgence in iran: A systematic review and meta-analysis of seroimmunity and diagnostic evidence.BMC infectious diseases · 2025Pooled it
- Pooled it
- Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2018Guideline
- A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants.BMC medicine · 2021Trial
- Factors associated with tetanus, diphtheria and pertussis (Tdap) vaccination acceptance among pregnant women: a cross-sectional study.BMC infectious diseases · 2026Article
- Safety Evaluation of Tetanus, Diphtheria, and Acellular Pertussis Vaccine (Tdap) During Pregnancy Among Vietnamese Women.Vaccines · 2025Article
- Review
- The Present and Future Aspects of Life-Long Pertussis Prevention: Narrative Review with Regional Perspectives for Türkiye.Infectious diseases and therapy · 2023Review
- Maternal vaccination: a review of current evidence and recommendations.American journal of obstetrics and gynecology · 2022Review
- Safety and use of tetanus-diphtheria-acellular pertussis-5 (Tdap5) vaccine during pregnancy: findings from 11 years of reporting to a pregnancy registry.Human vaccines & immunotherapeutics · 2021Article
- Comprehensive Overview of Vaccination during Pregnancy in Europe.Journal of personalized medicine · 2021Review
- Safety of Maternal Immunization Against Pertussis: A Systematic Review.Infectious diseases and therapy · 2019Review
- Adherence and Concordance of Influenza and Pertussis Vaccination Coverage in Pregnant Women in Spain.International journal of environmental research and public health · 2019Article
- Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort study.Human vaccines & immunotherapeutics · 2019Observational
- Neonatal Immunity toJournal of immunology research · 2019Review
- Article
- Article
- Immunological Tolerance, Pregnancy, and Preeclampsia: The Roles of Semen Microbes and the Father.Frontiers in medicine · 2017Article
- The safety of maternal immunization.Human vaccines & immunotherapeutics · 2016Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesActively 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.
participantsWomen 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.
results793 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.
conclusionsVaccination with Tdap in pregnant women was well tolerated with no SAE likely to be caused by the vaccine. TRIAL REGISTRATION NUMBER: ACTRN12613001045707.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.