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Efficacy of Maternal Influenza Vaccination Against All-Cause Lower Respiratory Tract Infection Hospitalizations in Young Infants: Results From a Randomized Controlled Trial.

ABSTRACT: Background:Influenza immunization of pregnant women protects their young infants against laboratory-confirmed influenza infection. Influenza infection might predispose to subsequent bacterial infections that cause severe pneumonia. In a secondary analysis of a randomized clinical trial (RCT), we evaluated the effect of maternal vaccination on infant hospitalizations for all-cause acute lower respiratory tract infection (ALRI). Methods:Infants born to women who participated in a double-blind placebo-controlled RCT in 2011 and 2012 on the efficacy of trivalent inactivated influenza vaccine (IIV) during pregnancy were followed during the first 6 months of life. Results:The study included 1026 infants born to IIV recipients and 1023 born to placebo recipients. There were 52 ALRI hospitalizations (median age, 72 days). The incidence (per 1000 infant-months) of ALRI hospitalizations was lower in infants born to IIV recipients (3.4 [95% confidence interval {CI}, 2.2-5.4]; 19 cases) compared with placebo recipients (6.0 [95% CI, 4.3-8.5]; 33 cases) with a vaccine efficacy of 43.1% (P = .050). Thirty of the ALRI hospitalizations occurred during the first 90 days of life, 9 in the IIV group (3.0 [95% CI, 1.6-5.9]) and 21 in the placebo group (7.2 [95% CI, 4.7-11.0]) (incidence rate ratio, 0.43 [95% CI, .19-.93]) for a vaccine efficacy of 57.5% (P = .032). The incidence of ALRI hospitalizations was similar in the IIV and placebo group for infants >3 months of age. Forty-four of the hospitalized infants were tested for influenza virus infection and 1 tested positive. Conclusions:Using an RCT as a vaccine probe, influenza vaccination during pregnancy decreased all-cause ALRI hospitalization during the first 3 months of life, suggesting possible protection against subsequent bacterial infections that influenza infection might predispose to. Clinical Trial Registration:NCT01306669.

SUBMITTER: Nunes MC

PROVIDER: S-EPMC5848298 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Efficacy of Maternal Influenza Vaccination Against All-Cause Lower Respiratory Tract Infection Hospitalizations in Young Infants: Results From a Randomized Controlled Trial.

Nunes Marta C MC Cutland Clare L CL Jones Stephanie S Downs Sarah S Weinberg Adriana A Ortiz Justin R JR Neuzil Kathleen M KM Simões Eric A F EAF Klugman Keith P KP Madhi Shabir A SA

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20171001 7

<h4>Background</h4>Influenza immunization of pregnant women protects their young infants against laboratory-confirmed influenza infection. Influenza infection might predispose to subsequent bacterial infections that cause severe pneumonia. In a secondary analysis of a randomized clinical trial (RCT), we evaluated the effect of maternal vaccination on infant hospitalizations for all-cause acute lower respiratory tract infection (ALRI).<h4>Methods</h4>Infants born to women who participated in a do ...[more]

PMID: 28575286

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Project description:ImportanceThe burden of influenza among young children is high, and influenza vaccination is the primary strategy to prevent the virus and its complications. Less is known about differences in clinical protection following 1 vs 2 doses of initial influenza vaccination.ObjectivesTo describe patterns of influenza vaccination among young children who receive outpatient care for acute respiratory tract illness in the US and compare vaccine effectiveness (VE) against medically attended laboratory-confirmed influenza by number of influenza vaccine doses received.DesignThis test-negative case-control study was conducted in outpatient clinics, including emergency departments, at 5 sites of the US Influenza Vaccine Effectiveness Network during the 2014-2015 through 2017-2018 influenza seasons. The present study was performed from November 5, 2014, to April 12, 2018, during periods of local influenza circulation. Children aged 6 months to 8 years with an acute respiratory tract illness with cough who presented for outpatient care within 7 days of illness onset were included. All children were tested using real-time, reverse-transcriptase polymerase chain reaction for influenza for research purposes.ExposuresVaccination in the enrollment season with either 1 or 2 doses of inactivated influenza vaccine as documented from electronic medical records, including state immunization information systems.Main outcomes and measuresMedically attended acute respiratory tract infection with real-time, reverse-transcriptase polymerase chain reaction testing for influenza.ResultsOf 7533 children, 3480 children (46%) were girls, 4687 children (62%) were non-Hispanic white, and 4871 children (65%) were younger than 5 years. A total of 3912 children (52%) were unvaccinated in the enrollment season, 2924 children (39%) were fully vaccinated, and 697 children (9%) were partially vaccinated. Adjusted VE against any influenza was 51% (95% CI, 44%-57%) among fully vaccinated children and 41% (95% CI, 25%-54%) among partially vaccinated children. Among 1519 vaccine-naive children aged 6 months to 2 years, the VE of 2 doses in the enrollment season was 53% (95% CI, 28%-70%), and the VE of 1 dose was 23% (95% CI, -11% to 47%); those who received 2 doses were less likely to test positive for influenza compared with children who received only 1 dose (adjusted odds ratio, 0.57; 95% CI, 0.35-0.93).Conclusions and relevanceConsistent with US influenza vaccine policy, receipt of the recommended number of doses resulted in higher VE than partial vaccination in 4 influenza seasons. Efforts to improve 2-dose coverage for previously unvaccinated children may reduce the burden of influenza in this population.

Project description:INTRODUCTION:Pertussis is an important public health problem worldwide, especially in infants. An increase in the incidence in many countries occurred after 2010, including Brazil. In 2013, dTpa vaccine was introduced in the Brazil national immunization schedule of pregnant women. The objective of this study was to evaluate the national trends in the incidence of pertussis in Brazil in children under 1 year old, and the impact of the introduction of dTpa vaccine during pregnancy. METHODS:The incidence of hospitalizations and non-hospitalized confirmed cases of pertussis in neonates (< 1 month age) and young infants (1 month-< 1 year age) were analyzed, comparing the incidence in pre maternal vaccination (2011-2013) with the post-vaccination (2015-2017). We used non-respiratory hospitalizations as comparison, during the same period. A database of the Brazilian Ministry of Health (DATASUS) was used to analyze cases from 2007 to 2017 and the subsets of 2011-2013 and 2015-2017, after Pertussis resurgence. The vaccination data was accessed through the link of the Information System of the National Immunization Program (pni.datasus.gov.br). RESULTS:Between 2007 and 2017, 17,818 children under one year of age were hospitalized due to pertussis in Brazil. In the pre maternal vaccination period 2011-2013, the mean annual incidence of non-hospitalized confirmed cases of pertussis in children under 1 month was 722.2 / 100,000 and in the period of 2015-2017 the average was 377.3 / 100,000, representing a decrease of 47.7% [IRR 0.52 (0.46-0.59)]. At those periods of time, the average incidence per year for children of one month-< 1 year aged was 64.9 / 100,000 (2011-2013) and 29.3 / 100,000 (2015-2017) [IRR 0.45 (CI 0.29-0.69)]. CONCLUSION:Vaccination of pregnant woman coincides with the reduction in the number of cases of pertussis in children under 1 month of age from 2015. Immunization of pregnant woman seems to have an important impact on the prevention of the disease in young infants who have not yet received their own pertussis vaccine.

Dataset Information

Efficacy of Maternal Influenza Vaccination Against All-Cause Lower Respiratory Tract Infection Hospitalizations in Young Infants: Results From a Randomized Controlled Trial.

Publications

Efficacy of Maternal Influenza Vaccination Against All-Cause Lower Respiratory Tract Infection Hospitalizations in Young Infants: Results From a Randomized Controlled Trial.

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