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Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: A population-based study in Taiwan

Identifieur interne : 001D98 ( PascalFrancis/Curation ); précédent : 001D97; suivant : 001D99

Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: A population-based study in Taiwan

Auteurs : Wan-Ting Huang [Taïwan] ; Fa-Wei Tang [Taïwan] ; Shu-Er Yang [Taïwan] ; Yi-Chien Chih [Taïwan] ; Jen-Hsiang Chuang [Taïwan]

Source :

RBID : Pascal:14-0276947

Descripteurs français

English descriptors

Abstract

Background: Pregnant women were prioritized for H1N1 vaccination during the 2009-2010 pandemic. Safety concerns exist with vaccinating pregnant women, particularly in their first trimesters. Methods: We linked computerized data on H1N1 vaccination, National Health Insurance, and Taiwan Birth Registry and identified events of spontaneous abortions (SABs) and all singleton births that occurred/delivered during November 1, 2009-September 30, 2010. The observation period for each case of SAB (6-19 weeks gestation) was divided into period at risk (1-28 days after vaccination) and control periods (the remaining person-days until SAB). The self-controlled case series method for truncated observational periods assessed the incidence rate ratio (IRR) of SAB during the 1-28 days compared with those in the control period. The case-control design matched each case of adverse fetal outcomes to up to 10 controls on fetal sex and year/month of pregnancy onset, and calculated matched odds ratio (OR) on H1N1 vaccination at <14 or ≥ 14 weeks gestation. Results: Sixty-five women with SAB had received H1N1 vaccination at 6-19 weeks gestation. The IRR of SAB for the risk period 1-28 days was 1.03 (95% confidence interval [CI] 0.55-1.93). Among the 147,294 live births and 1354 stillbirths, maternal H1N1 vaccine receipt at <14 weeks gestation was associated with significantly reduced likelihood of small for gestational age (SGA) birth (OR 0.72, 95% CI 0.61-0.84) and birth defect (OR 0.46,95% CI 0.22-1.00), whereas receipt at ≥14 weeks gestation was associated with significantly reduced likelihood of stillbirth (OR 0.63, 95% CI 0.46-0.86), prematurity (OR 0.90, 95% CI 0.83-0.97), low birth weight (OR 0.81, 95% CI 0.74-0.88), and SGA birth (OR 0.90, 95% CI 0.84-0.97). Conclusions: H1N1 vaccination during pregnancy did not increase risk of SAB or adverse fetal outcomes.
pA  
A01 01  1    @0 0264-410X
A02 01      @0 VACCDE
A03   1    @0 Vaccine
A05       @2 32
A06       @2 48
A08 01  1  ENG  @1 Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: A population-based study in Taiwan
A11 01  1    @1 HUANG (Wan-Ting)
A11 02  1    @1 TANG (Fa-Wei)
A11 03  1    @1 YANG (Shu-Er)
A11 04  1    @1 CHIH (Yi-Chien)
A11 05  1    @1 CHUANG (Jen-Hsiang)
A14 01      @1 Taiwan Centers for Disease Control, 6 Linsen S. Road @2 Taipei 10050 @3 TWN @Z 1 aut. @Z 2 aut. @Z 3 aut. @Z 4 aut. @Z 5 aut.
A14 02      @1 Institute of Biomedical Informatics & Institute of Public Health, National Yang-Ming University, 155 Section 2, Linong Street @2 Taipei 11221 @3 TWN @Z 5 aut.
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A21       @1 2014
A23 01      @0 ENG
A43 01      @1 INIST @2 20289 @5 354000502696130230
A44       @0 0000 @1 © 2014 INIST-CNRS. All rights reserved.
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C01 01    ENG  @0 Background: Pregnant women were prioritized for H1N1 vaccination during the 2009-2010 pandemic. Safety concerns exist with vaccinating pregnant women, particularly in their first trimesters. Methods: We linked computerized data on H1N1 vaccination, National Health Insurance, and Taiwan Birth Registry and identified events of spontaneous abortions (SABs) and all singleton births that occurred/delivered during November 1, 2009-September 30, 2010. The observation period for each case of SAB (6-19 weeks gestation) was divided into period at risk (1-28 days after vaccination) and control periods (the remaining person-days until SAB). The self-controlled case series method for truncated observational periods assessed the incidence rate ratio (IRR) of SAB during the 1-28 days compared with those in the control period. The case-control design matched each case of adverse fetal outcomes to up to 10 controls on fetal sex and year/month of pregnancy onset, and calculated matched odds ratio (OR) on H1N1 vaccination at <14 or ≥ 14 weeks gestation. Results: Sixty-five women with SAB had received H1N1 vaccination at 6-19 weeks gestation. The IRR of SAB for the risk period 1-28 days was 1.03 (95% confidence interval [CI] 0.55-1.93). Among the 147,294 live births and 1354 stillbirths, maternal H1N1 vaccine receipt at <14 weeks gestation was associated with significantly reduced likelihood of small for gestational age (SGA) birth (OR 0.72, 95% CI 0.61-0.84) and birth defect (OR 0.46,95% CI 0.22-1.00), whereas receipt at ≥14 weeks gestation was associated with significantly reduced likelihood of stillbirth (OR 0.63, 95% CI 0.46-0.86), prematurity (OR 0.90, 95% CI 0.83-0.97), low birth weight (OR 0.81, 95% CI 0.74-0.88), and SGA birth (OR 0.90, 95% CI 0.84-0.97). Conclusions: H1N1 vaccination during pregnancy did not increase risk of SAB or adverse fetal outcomes.
C02 01  X    @0 002A05F04
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C03 02  X  SPA  @0 Vacunación @5 05
C03 03  X  FRE  @0 Gestation @5 06
C03 03  X  ENG  @0 Pregnancy @5 06
C03 03  X  SPA  @0 Gestación @5 06
C03 04  X  FRE  @0 Taiwan @2 NG @5 07
C03 04  X  ENG  @0 Taiwan @2 NG @5 07
C03 04  X  SPA  @0 Taiwan @2 NG @5 07
C03 05  X  FRE  @0 Adjuvant immunologique @5 08
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C03 05  X  SPA  @0 Coadyuvante inmunológico @5 08
C03 06  X  FRE  @0 Vaccin @5 09
C03 06  X  ENG  @0 Vaccine @5 09
C03 06  X  SPA  @0 Vacuna @5 09
C03 07  X  FRE  @0 Virus grippal A(H1N1) @4 CD @5 96
C03 07  X  ENG  @0 Influenzavirus A(H1N1) @4 CD @5 96
C07 01  X  FRE  @0 Influenzavirus A @2 NW
C07 01  X  ENG  @0 Influenzavirus A @2 NW
C07 01  X  SPA  @0 Influenzavirus A @2 NW
C07 02  X  FRE  @0 Orthomyxoviridae @2 NW
C07 02  X  ENG  @0 Orthomyxoviridae @2 NW
C07 02  X  SPA  @0 Orthomyxoviridae @2 NW
C07 03  X  FRE  @0 Virus @2 NW
C07 03  X  ENG  @0 Virus @2 NW
C07 03  X  SPA  @0 Virus @2 NW
C07 04  X  FRE  @0 Asie @2 NG
C07 04  X  ENG  @0 Asia @2 NG
C07 04  X  SPA  @0 Asia @2 NG
C07 05  X  FRE  @0 Extrême Orient @2 NG @5 13
C07 05  X  ENG  @0 Far east @2 NG @5 13
C07 05  X  SPA  @0 Extremo Oriente @2 NG @5 13
C07 06  X  FRE  @0 Zone subtropicale @5 16
C07 06  X  ENG  @0 Subtropical zone @5 16
C07 06  X  SPA  @0 Zona subtropical @5 16
N21       @1 349
N44 01      @1 OTO
N82       @1 OTO

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Pascal:14-0276947

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<div type="abstract" xml:lang="en">Background: Pregnant women were prioritized for H1N1 vaccination during the 2009-2010 pandemic. Safety concerns exist with vaccinating pregnant women, particularly in their first trimesters. Methods: We linked computerized data on H1N1 vaccination, National Health Insurance, and Taiwan Birth Registry and identified events of spontaneous abortions (SABs) and all singleton births that occurred/delivered during November 1, 2009-September 30, 2010. The observation period for each case of SAB (6-19 weeks gestation) was divided into period at risk (1-28 days after vaccination) and control periods (the remaining person-days until SAB). The self-controlled case series method for truncated observational periods assessed the incidence rate ratio (IRR) of SAB during the 1-28 days compared with those in the control period. The case-control design matched each case of adverse fetal outcomes to up to 10 controls on fetal sex and year/month of pregnancy onset, and calculated matched odds ratio (OR) on H1N1 vaccination at <14 or ≥ 14 weeks gestation. Results: Sixty-five women with SAB had received H1N1 vaccination at 6-19 weeks gestation. The IRR of SAB for the risk period 1-28 days was 1.03 (95% confidence interval [CI] 0.55-1.93). Among the 147,294 live births and 1354 stillbirths, maternal H1N1 vaccine receipt at <14 weeks gestation was associated with significantly reduced likelihood of small for gestational age (SGA) birth (OR 0.72, 95% CI 0.61-0.84) and birth defect (OR 0.46,95% CI 0.22-1.00), whereas receipt at ≥14 weeks gestation was associated with significantly reduced likelihood of stillbirth (OR 0.63, 95% CI 0.46-0.86), prematurity (OR 0.90, 95% CI 0.83-0.97), low birth weight (OR 0.81, 95% CI 0.74-0.88), and SGA birth (OR 0.90, 95% CI 0.84-0.97). Conclusions: H1N1 vaccination during pregnancy did not increase risk of SAB or adverse fetal outcomes.</div>
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<s0>Background: Pregnant women were prioritized for H1N1 vaccination during the 2009-2010 pandemic. Safety concerns exist with vaccinating pregnant women, particularly in their first trimesters. Methods: We linked computerized data on H1N1 vaccination, National Health Insurance, and Taiwan Birth Registry and identified events of spontaneous abortions (SABs) and all singleton births that occurred/delivered during November 1, 2009-September 30, 2010. The observation period for each case of SAB (6-19 weeks gestation) was divided into period at risk (1-28 days after vaccination) and control periods (the remaining person-days until SAB). The self-controlled case series method for truncated observational periods assessed the incidence rate ratio (IRR) of SAB during the 1-28 days compared with those in the control period. The case-control design matched each case of adverse fetal outcomes to up to 10 controls on fetal sex and year/month of pregnancy onset, and calculated matched odds ratio (OR) on H1N1 vaccination at <14 or ≥ 14 weeks gestation. Results: Sixty-five women with SAB had received H1N1 vaccination at 6-19 weeks gestation. The IRR of SAB for the risk period 1-28 days was 1.03 (95% confidence interval [CI] 0.55-1.93). Among the 147,294 live births and 1354 stillbirths, maternal H1N1 vaccine receipt at <14 weeks gestation was associated with significantly reduced likelihood of small for gestational age (SGA) birth (OR 0.72, 95% CI 0.61-0.84) and birth defect (OR 0.46,95% CI 0.22-1.00), whereas receipt at ≥14 weeks gestation was associated with significantly reduced likelihood of stillbirth (OR 0.63, 95% CI 0.46-0.86), prematurity (OR 0.90, 95% CI 0.83-0.97), low birth weight (OR 0.81, 95% CI 0.74-0.88), and SGA birth (OR 0.90, 95% CI 0.84-0.97). Conclusions: H1N1 vaccination during pregnancy did not increase risk of SAB or adverse fetal outcomes.</s0>
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<s0>Virus grippal A</s0>
<s2>NW</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Influenza A virus</s0>
<s2>NW</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Influenza A virus</s0>
<s2>NW</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Vaccination</s0>
<s5>05</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Vaccination</s0>
<s5>05</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Vacunación</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Gestation</s0>
<s5>06</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Pregnancy</s0>
<s5>06</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Gestación</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Taiwan</s0>
<s2>NG</s2>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Taiwan</s0>
<s2>NG</s2>
<s5>07</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Taiwan</s0>
<s2>NG</s2>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Adjuvant immunologique</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Immunological adjuvant</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Coadyuvante inmunológico</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Vaccin</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Vaccine</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Vacuna</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Virus grippal A(H1N1)</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Influenzavirus A(H1N1)</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Asie</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Asia</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Asia</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Extrême Orient</s0>
<s2>NG</s2>
<s5>13</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Far east</s0>
<s2>NG</s2>
<s5>13</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Extremo Oriente</s0>
<s2>NG</s2>
<s5>13</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Zone subtropicale</s0>
<s5>16</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Subtropical zone</s0>
<s5>16</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Zona subtropical</s0>
<s5>16</s5>
</fC07>
<fN21>
<s1>349</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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