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Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women.

Publication ,  Journal Article
Munoz, FM; Jackson, LA; Swamy, GK; Edwards, KM; Frey, SE; Stephens, I; Ault, K; Winokur, P; Petrie, CR; Wolff, M; Patel, SM; Keitel, WA
Published in: Vaccine
December 18, 2018

BACKGROUND: In the United States, seasonal inactivated influenza vaccine (IIV) is recommended for pregnant women; however, in early 2009, immunization rates were low, partly due to limited prospective data and concerns about vaccine safety. OBJECTIVE: We conducted a randomized study of two licensed seasonal trivalent IIVs (IIV3) to assess their safety and immunogenicity in pregnant women. STUDY DESIGN: In this prospective, randomized clinical study, 100 pregnant women, 18-39 years of age and ≥14 weeks gestation received a single intramuscular dose of 2008-2009 Fluzone® or Fluarix®. Injection site and systemic reactions were recorded for 7 days after vaccination and serious adverse events (SAEs) and pregnancy outcomes were documented. Serum samples collected before and 28 days after vaccination were tested for hemagglutination inhibition (HAI) antibody levels. RESULTS: The majority of the injection site and systemic reactions were mild and self-limited after both vaccines. No fever ≥100 °F was reported. There were no vaccine-associated SAEs. Immune responses to influenza vaccine antigens were similar for the two study vaccines, with robust HAI responses against influenza A strains, and relatively lower responses for influenza B strains. CONCLUSION: Seasonal inactivated influenza vaccines were well tolerated and immunogenic in pregnant women. SYNOPSIS: In this prospective clinical trial, we demonstrated that immunization with seasonal trivalent, inactivated influenza vaccine in the second and third trimester of pregnancy is immunogenic and safe.

Duke Scholars

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Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

December 18, 2018

Volume

36

Issue

52

Start / End Page

8054 / 8061

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Virology
  • Vaccines, Inactivated
  • Vaccination
  • United States
  • Seasons
  • Prospective Studies
  • Pregnancy Complications, Infectious
  • Pregnancy
  • Influenza, Human
 

Citation

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Munoz, F. M., Jackson, L. A., Swamy, G. K., Edwards, K. M., Frey, S. E., Stephens, I., … Keitel, W. A. (2018). Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women. Vaccine, 36(52), 8054–8061. https://doi.org/10.1016/j.vaccine.2018.10.088
Munoz, Flor M., Lisa A. Jackson, Geeta K. Swamy, Kathryn M. Edwards, Sharon E. Frey, Ina Stephens, Kevin Ault, et al. “Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women.Vaccine 36, no. 52 (December 18, 2018): 8054–61. https://doi.org/10.1016/j.vaccine.2018.10.088.
Munoz FM, Jackson LA, Swamy GK, Edwards KM, Frey SE, Stephens I, et al. Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women. Vaccine. 2018 Dec 18;36(52):8054–61.
Munoz, Flor M., et al. “Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women.Vaccine, vol. 36, no. 52, Dec. 2018, pp. 8054–61. Pubmed, doi:10.1016/j.vaccine.2018.10.088.
Munoz FM, Jackson LA, Swamy GK, Edwards KM, Frey SE, Stephens I, Ault K, Winokur P, Petrie CR, Wolff M, Patel SM, Keitel WA. Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women. Vaccine. 2018 Dec 18;36(52):8054–8061.
Journal cover image

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

December 18, 2018

Volume

36

Issue

52

Start / End Page

8054 / 8061

Location

Netherlands

Related Subject Headings

  • Young Adult
  • Virology
  • Vaccines, Inactivated
  • Vaccination
  • United States
  • Seasons
  • Prospective Studies
  • Pregnancy Complications, Infectious
  • Pregnancy
  • Influenza, Human