Evidence map›Paper›PMID 29961606›Full record

Trial reportVaccine2018

Randomized trial comparing the safety and antibody responses to live attenuated versus inactivated influenza vaccine when administered to breastfeeding women.

Rebecca C Brady, Lisa A Jackson, Sharon E Frey, Andi L Shane, Emmanuel B Walter, Geeta K Swamy, Elizabeth P Schlaudecker, Elena Szefer, Mark Wolff, Monica Malone McNeal and 2 more

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2018. 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
1.5field-weighted citation impact, top 18% 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, 24 citations in OpenAlex.

  1. Review
  2. Article
  3. Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Influenza in Children.Cold Spring Harbor perspectives in medicine · 2021
    Review
  15. Article
  16. Review
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

12 authors at 6 institutions in 1 country.

Rebecca C BradyCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: rebecca.brady@cchmc.org.
Lisa A JacksonGroup Health Research Institute, Seattle, WA, USA.
Sharon E FreySaint Louis University, St. Louis, MO, USA.
Andi L ShaneEmory Children's Center, Atlanta, GA, USA.
Emmanuel B WalterDuke University, Durham, NC, USA.
Geeta K SwamyDuke University, Durham, NC, USA.
Elizabeth P SchlaudeckerCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Elena SzeferThe EMMES Corporation, Rockville, MD, USA.
Mark WolffThe EMMES Corporation, Rockville, MD, USA.
Monica Malone McNealCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
David I BernsteinCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Mark C SteinhoffCincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Cincinnati Children's Hospital Medical Center · USDuke University · USEmmes (United States) · USChildren's Center · USKaiser Permanente Washington Health Research Institute · USSaint Louis University · US

Funding

EVALUATION OF CONTROL MEASURES AGAINST DISEASES OTHER THAN AIDS-266025459N01AI025459 · NIAID · CHILDREN'S HOSPITAL MEDICAL CE · PI BERNSTEIN, DAVID · 2002 to 2006
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NIAID NIH HHS HHSN272200800001CNIAID NIH HHS HHSN272200800001GNIAID NIH HHS HHSN272200800001INIAID NIH HHS HHSN272200800001ONIAID NIH HHS HHSN272200800003CNIAID NIH HHS HHSN272200800004CNIAID NIH HHS HHSN272200800005CNIAID NIH HHS HHSN272200800006CNIAID NIH HHS HHSN272200800007CNIAID NIH HHS HHSN272200800013CNIAID NIH HHS HHSN272200800057CNIAID NIH HHS N01 AI025459NICHD NIH HHS HHSN267200800009C
6 · The paper itself

Abstract

backgroundLive attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) are both licensed for administration to nursing mothers. Little is known about the potential for transmission of LAIV viruses from the mother to the infant and the comparative breast milk antibody responses to LAIV and IIV.

methodsWe performed a randomized, double-blind study comparing the immunogenicity of LAIV to IIV when administered to nursing mothers. The safety of LAIV to IIV in women and their infants was also compared. Women received LAIV + intramuscular placebo, or IIV + intranasal placebo on Day 0. Breast milk and nasal swabs (from women and infants) were collected on Days 0, 2, and 8 for detection of LAIV. Breast milk and serum antibody responses were measured at Days 0 and 28. The primary hypothesis was that LAIV would provide superior induction of breast milk IgA responses to influenza as compared to IIV when administered to nursing mothers.

resultsBreast milk IgG, breast milk IgA (H1N1 only), serum hemagglutination inhibition (HAI), and serum IgG responses were significantly higher following administration of IIV compared to LAIV. Receipt of either LAIV or IIV was safe in women and their infants. One (1%) LAIV recipient transmitted vaccine virus to her infant who remained well. No influenza virus was detected in breast milk.

conclusionsBreast milk and serum antibody responses were higher for IIV compared to LAIV. LAIV and IIV were safe for nursing women but there was one (1%) possible transmission of LAIV to an infant. This study suggests that IIV may be the preferred vaccine for nursing mothers.

Indexed as

Antibody FormationAdministration, IntranasalAdolescentAdultAntibodies, ViralBreast FeedingDouble-Blind MethodFemaleHumansImmunoglobulin AImmunoglobulin GInfantInfant, NewbornInfluenza VaccinesInjections, IntramuscularMaleAntibodies, ViralImmunoglobulin AImmunoglobulin GInfluenza VaccinesPlacebosVaccines, AttenuatedVaccines, InactivatedBreastfeedingImmunogenicityInactivated influenza vaccineInfantsLive attenuated influenza vaccineSafety

Identifiers

PMID29961606
PMCPMC8785652
OpenAlexW2810749842

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.