Evidence map›Paper›PMID 34082643›Full record

Observational studyHuman vaccines & immunotherapeutics2022

Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry.

Ugo Nwoji

Registry-linked trialOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in Human vaccines & immunotherapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02148211 (Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Pregnancy Registry), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 23% 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.

NCT02148211 completednot on this map

Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Fluarix or Fluarix Quadrivalent or FluLaval or FluLaval Quadrivalent During Pregnancy or Within 28 Days Preceding Conception.

TypeobservationalSponsorGlaxoSmithKlineRan2014 to 2019Enrolled507ConditionsInfluenzaArmsData collection
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. 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
    Article
  5. Maternal vaccination-current status, challenges, and opportunities.The journal of obstetrics and gynaecology research · 2023
    Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author at 1 institution in 1 country.

Ugo NwojiGSK, Rockville, MD, USA.ORCID 0000-0002-2946-703X
GlaxoSmithKline (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The World Health Organization recommends that all pregnant women receive seasonal influenza vaccine. Under a post-authorization safety study protocol (NCT02148211), a pregnancy exposure registry was established in the United States to monitor spontaneously reported pregnancy outcomes in women vaccinated with GSK's seasonal inactivated influenza vaccines (IIVs). From 1 June 2014 to 31 May 2019, 507 pregnancies were prospectively reported: 352 (69.4%) were lost to follow-up and 40 (7.9%) were ongoing. Reported outcomes for the remaining 115 were: 101 (87.8%) live births without congenital anomalies; 3 (2.6%) live births with congenital anomalies; 2 (1.7%) spontaneous abortions with no congenital anomalies; 1 (0.9%) spontaneous abortion with a congenital anomaly; 1 stillbirth with no apparent congenital anomaly; 7 (6.1%) 'Unknown'. Results from 493 prospective reports received via worldwide spontaneous, passive surveillance showed similar outcomes. All cases with congenital anomaly were assessed as not likely/unlikely/unrelated to vaccination. Despite the limited number of cases and outcomes, no safety signal was identified. The study findings are aligned with previously published data and should be confirmed with other robust data sources.

Indexed as

Abortion, SpontaneousInfluenza, HumanInfluenza VaccinesFemaleHumansPregnancyPregnancy OutcomeProspective StudiesRegistriesSeasonsUnited StatesVaccinationVaccines, InactivatedInfluenza VaccinesVaccines, Inactivatedbirth defectsinfluenza vaccinepregnancy registrysafetyspontaneous abortion

Identifiers

PMID34082643
PMCPMC8920223
OpenAlexW3165029776

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.