Evidence map›Paper›PMID 28917295›Full record

ArticleVaccine2017

Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12.

James G Donahue, Burney A Kieke, Jennifer P King, Frank DeStefano, Maria A Mascola, Stephanie A Irving, T Craig Cheetham, Jason M Glanz, Lisa A Jackson, Nicola P Klein and 3 more

Open access · greenAbstract read
In one paragraph

Article in Vaccine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 8 pooled it
11.9field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 8 syntheses or guidelines pooled it, 109 citations in OpenAlex.

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  13. Summary of the National Advisory Committee on Immunization (NACI) Updated Guidance on Influenza Vaccination During Pregnancy.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

James G DonahueMarshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: donahue.james@mcrf.mfldclin.edu.
Burney A KiekeMarshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: kieke.burney@mcrf.mfldclin.edu.
Jennifer P KingMarshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: king.jennifer@mcrf.mfldclin.edu.
Frank DeStefanoCenters for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS-D26 Atlanta, GA 30333, United States. Electronic address: fxd1@cdc.gov.
Maria A MascolaMarshfield Clinic, Department of Obstetrics and Gynecology, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: mascola.maria@marshfieldclinic.org.
Stephanie A IrvingKaiser Permanente Northwest, 3800 N. Interstate Ave, Portland, OR 97227, United States. Electronic address: stephanie.a.irving@kpchr.org.
T Craig CheethamKaiser Permanente Southern California, 100 S. Los Robles Ave., 2nd Floor, Pasadena, CA 91101, United States. Electronic address: craig.t.cheetham@kp.org.
Jason M GlanzKaiser Permanente Colorado, 10065 E. Harvard, Suite 300, Denver, CO 80231, United States. Electronic address: jason.m.glanz@kp.org.
Lisa A JacksonGroup Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, United States. Electronic address: jackson.l@ghc.org.
Nicola P KleinKaiser Permanente Northern California, 1 Kaiser Plaza, 16th Floor, Oakland, CA 94612, United States. Electronic address: Nicola.Klein@kp.org.
Allison L NalewayKaiser Permanente Northwest, 3800 N. Interstate Ave, Portland, OR 97227, United States. Electronic address: Allison.Naleway@kpchr.org.
Eric WeintraubCenters for Disease Control and Prevention, Immunization Safety Office, 1600 Clifton Road NE, MS-D26 Atlanta, GA 30333, United States. Electronic address: eiw8@cdc.gov.
Edward A BelongiaMarshfield Clinic Research Institute, 1000 N. Oak Ave, Marshfield, WI 54449, United States. Electronic address: belongia.edward@marshfieldclinic.org.
Kaiser Permanente · USMarshfield Clinic · USCenters for Disease Control and Prevention · USKaiser Permanente Washington Health Research Institute · USNational Center for Immunization and Respiratory Diseases · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

introductionInactivated influenza vaccine is recommended in any stage of pregnancy, but evidence of safety in early pregnancy is limited, including for vaccines containing A/H1N1pdm2009 (pH1N1) antigen. We sought to determine if receipt of vaccine containing pH1N1 was associated with spontaneous abortion (SAB).

methodsWe conducted a case-control study over two influenza seasons (2010-11, 2011-12) in the Vaccine Safety Datalink. Cases had SAB and controls had live births or stillbirths and were matched on site, date of last menstrual period, and age. Of 919 potential cases identified using diagnosis codes, 485 were eligible and confirmed by medical record review. Exposure was defined as vaccination with inactivated influenza vaccine before the SAB date; the primary exposure window was the 1-28days before the SAB.

resultsThe overall adjusted odds ratio (aOR) was 2.0 (95% CI, 1.1-3.6) for vaccine receipt in the 28-day exposure window; there was no association in other exposure windows. In season-specific analyses, the aOR in the 1-28days was 3.7 (95% CI 1.4-9.4) in 2010-11 and 1.4 (95% CI 0.6-3.3) in 2011-12. The association was modified by influenza vaccination in the prior season (post hoc analysis). Among women who received pH1N1-containing vaccine in the previous influenza season, the aOR in the 1-28days was 7.7 (95% CI 2.2-27.3); the aOR was 1.3 (95% CI 0.7-2.7) among women not vaccinated in the previous season. This effect modification was observed in each season.

conclusionSAB was associated with influenza vaccination in the preceding 28days. The association was significant only among women vaccinated in the previous influenza season with pH1N1-containing vaccine. This study does not and cannot establish a causal relationship between repeated influenza vaccination and SAB, but further research is warranted.

Indexed as

Abortion, SpontaneousAdultCase-Control StudiesFemaleHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesOdds RatioPregnancyVaccines, InactivatedYoung AdultInfluenza VaccinesVaccines, InactivatedInfluenzaInfluenza vaccinePregnancySpontaneous abortion

Identifiers

PMID28917295
PMCPMC6501798
OpenAlexW2756306165

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.