tetano
Editor, Senior Moderator
Vaccine. 2018 Nov 8. pii: S0264-410X(18)31475-0. doi: 10.1016/j.vaccine.2018.10.088. [Epub ahead of print]
[h=1]Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women.[/h] Munoz FM[SUP]1[/SUP], Jackson LA[SUP]2[/SUP], Swamy GK[SUP]3[/SUP], Edwards KM[SUP]4[/SUP], Frey SE[SUP]5[/SUP], Stephens I[SUP]6[/SUP], Ault K[SUP]7[/SUP], Winokur P[SUP]8[/SUP], Petrie CR[SUP]9[/SUP], Wolff M[SUP]9[/SUP], Patel SM[SUP]10[/SUP], Keitel WA[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] We conducted a randomized study of two licensed seasonal trivalent IIVs (IIV3) to assess their safety and immunogenicity in pregnant women.
[h=4]STUDY DESIGN:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] Seasonal inactivated influenza vaccines were well tolerated and immunogenic in pregnant women.
[h=4]SYNOPSIS:[/h] 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.
Copyright ? 2018 Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Influenza vaccine; Maternal immunization; Pregnant women
PMID: 30416018 DOI: 10.1016/j.vaccine.2018.10.088
[h=1]Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women.[/h] Munoz FM[SUP]1[/SUP], Jackson LA[SUP]2[/SUP], Swamy GK[SUP]3[/SUP], Edwards KM[SUP]4[/SUP], Frey SE[SUP]5[/SUP], Stephens I[SUP]6[/SUP], Ault K[SUP]7[/SUP], Winokur P[SUP]8[/SUP], Petrie CR[SUP]9[/SUP], Wolff M[SUP]9[/SUP], Patel SM[SUP]10[/SUP], Keitel WA[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] We conducted a randomized study of two licensed seasonal trivalent IIVs (IIV3) to assess their safety and immunogenicity in pregnant women.
[h=4]STUDY DESIGN:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] Seasonal inactivated influenza vaccines were well tolerated and immunogenic in pregnant women.
[h=4]SYNOPSIS:[/h] 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.
Copyright ? 2018 Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Influenza vaccine; Maternal immunization; Pregnant women
PMID: 30416018 DOI: 10.1016/j.vaccine.2018.10.088