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Research on vaccines during pregnancy: protocol design and assessment of safety.

Publication ,  Journal Article
Munoz, FM; Sheffield, JS; Beigi, RH; Read, JS; Swamy, GK; Jevaji, I; Rasmussen, SA; Edwards, KM; Fortner, KB; Patel, SM; Spong, CY; Ault, K ...
Published in: Vaccine
September 13, 2013

The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.

Duke Scholars

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

September 13, 2013

Volume

31

Issue

40

Start / End Page

4274 / 4279

Location

Netherlands

Related Subject Headings

  • Virology
  • Vaccines
  • Vaccination
  • Research Design
  • Pregnancy Complications, Infectious
  • Pregnancy
  • Infant, Newborn, Diseases
  • Infant, Newborn
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Munoz, F. M., Sheffield, J. S., Beigi, R. H., Read, J. S., Swamy, G. K., Jevaji, I., … Nesin, M. (2013). Research on vaccines during pregnancy: protocol design and assessment of safety. Vaccine, 31(40), 4274–4279. https://doi.org/10.1016/j.vaccine.2013.07.042
Munoz, Flor M., Jeanne S. Sheffield, Richard H. Beigi, Jennifer S. Read, Geeta K. Swamy, Indira Jevaji, Sonja A. Rasmussen, et al. “Research on vaccines during pregnancy: protocol design and assessment of safety.Vaccine 31, no. 40 (September 13, 2013): 4274–79. https://doi.org/10.1016/j.vaccine.2013.07.042.
Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I, et al. Research on vaccines during pregnancy: protocol design and assessment of safety. Vaccine. 2013 Sep 13;31(40):4274–9.
Munoz, Flor M., et al. “Research on vaccines during pregnancy: protocol design and assessment of safety.Vaccine, vol. 31, no. 40, Sept. 2013, pp. 4274–79. Pubmed, doi:10.1016/j.vaccine.2013.07.042.
Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I, Rasmussen SA, Edwards KM, Fortner KB, Patel SM, Spong CY, Ault K, Heine RP, Nesin M. Research on vaccines during pregnancy: protocol design and assessment of safety. Vaccine. 2013 Sep 13;31(40):4274–4279.
Journal cover image

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

September 13, 2013

Volume

31

Issue

40

Start / End Page

4274 / 4279

Location

Netherlands

Related Subject Headings

  • Virology
  • Vaccines
  • Vaccination
  • Research Design
  • Pregnancy Complications, Infectious
  • Pregnancy
  • Infant, Newborn, Diseases
  • Infant, Newborn
  • Humans
  • Female