Evidence map›Paper›PMID 32571718›Full record

Trial reportVaccine2020

Safety and immunogenicity of three seasonal inactivated influenza vaccines among pregnant women and antibody persistence in their infants.

Flor M Munoz, Shital M Patel, Lisa A Jackson, Geeta K Swamy, Kathryn M Edwards, Sharon E Frey, Carey R Petrie, Eli A Sendra, Wendy A Keitel

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.3field-weighted citation impact, top 11% 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

16 citing papers in PubMed, 27 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  5. Vaccine and Treatment Evaluation Units: A Historical Perspective.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  6. Review
  7. Observational
  8. Review
  9. Review
  10. Review
  11. Observational
  12. Article
  13. Congenital Human Cytomegalovirus Infection Is Associated With Decreased Transplacental IgG Transfer Efficiency Due to Maternal Hypergammaglobulinemia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  14. The association of maternal SARS-CoV-2 vaccination-to-delivery interval and the levels of maternal and cord blood antibodies.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2022
    Article
  15. Article
  16. 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

9 authors at 6 institutions in 1 country.

Flor M MunozDepartment of Pediatrics, Houston, TX, United States; Department of Molecular Virology and Microbiology, Houston, TX, United States. Electronic address: florm@bcm.edu.
Shital M PatelDepartment of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States.
Lisa A JacksonKaiser Permanente Washington Health Research Institute, Seattle, WA, United States.
Geeta K SwamyDepartment of Obstetrics & Gynecology, Duke University, Durham, NC, United States.
Kathryn M EdwardsVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TN, United States.
Sharon E FreySaint Louis University School of Medicine, St. Louis, MO, United States.
Carey R PetrieThe EMMES Company, LLC, Rockville, MD, United States.
Eli A SendraThe EMMES Company, LLC, Rockville, MD, United States.
Wendy A KeitelDepartment of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States.
Baylor College of Medicine · USEmmes (United States) · USDuke University · USKaiser Permanente Washington Health Research Institute · USSaint Louis University · USVanderbilt University · US

Funding

EVALUATION OF CONTROL MEASURES AGAINST DISEASES OTHER THAN AIDS-266025465N01AI025465 · NIAID · BAYLOR COLLEGE OF MEDICINE INC · PI KEITEL, WENDY A · 2002 to 2006
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NIAID NIH HHS HHSN272200800002CNIAID NIH HHS HHSN272200800003CNIAID NIH HHS HHSN272200800004CNIAID NIH HHS HHSN272200800007CNIAID NIH HHS HHSN272200800057CNIAID NIH HHS HHSN272201300015CNIAID NIH HHS HHSN272201300015INIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201300019CNIAID NIH HHS HHSN272201300019INIAID NIH HHS HHSN272201300021INIAID NIH HHS HHSN272201300023CNIAID NIH HHS HHSN272201300023INIAID NIH HHS HHSN272201500002CNIAID NIH HHS N01 AI025465
6 · The paper itself

Abstract

objectiveInactivated influenza virus vaccines (IIVs) are recommended for all pregnant women in the United States. We conducted a prospective, randomized, double blind study of three licensed seasonal trivalent IIVs (IIV3s) to assess their safety and immunogenicity in pregnant women and determine the level and persistence of passively transferred maternal antibody in infants. STUDY

design139 pregnant women ages 18-39 years and 14-33 weeks' gestation, and 44 non-pregnant women, were randomized 1:1:1 to receive a single intramuscular dose of one of three licensed IIV3s (Agriflu®, Fluzone®, or Fluarix®) prior to the 2010-2011 influenza season. Reactogenicity, adverse events (AEs) and pregnancy outcomes were documented. Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays were collected prior to and 28 and 180 days after immunization. Maternal sera and cord blood were collected at the time of delivery and sera were obtained from 44 infants at 6 weeks of age.

resultsPregnant and non-pregnant women experienced similar frequency of injection site (92% and 86%, respectively) and systemic (95% and 87%, respectively) reactions, the majority of which were mild. There were no vaccine-associated maternal or infant serious AEs. Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women. The ratios of cord blood (infant) to maternal HAI antibody titers at delivery ranged between 1.1 and 1.7 for each of the vaccine antigens. Influenza antibody concentrations in infants were 70-40% of the birth titer by 6 weeks of age.

conclusionsThe three IIV3s were well tolerated in pregnant women. Antibody responses were comparable in pregnant and non-pregnant women, and after second or third trimester vaccination. Transplacental transfer of maternal antibodies to the infant was efficient. However, antibody titers decline rapidly in the first 6 weeks of life.

Indexed as

Influenza, HumanInfluenza VaccinesAdolescentAdultAntibodies, ViralFemaleHemagglutination Inhibition TestsHumansInfantPregnancyPregnant PeopleProspective StudiesSeasonsVaccines, InactivatedYoung AdultAntibodies, ViralInfluenza VaccinesVaccines, InactivatedAntibody persistenceIIV3InfantInfluenza vaccineMaternal immunizationPassive antibody transferPregnant women

Identifiers

PMID32571718
PMCPMC10803065
OpenAlexW3036272154

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.