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

Identifieur interne : 000021 ( PascalFrancis/Corpus ); précédent : 000020; suivant : 000022

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

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

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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.
A20       @1 6463-6468
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.
A45       @0 35 ref.
A47 01  1    @0 14-0276947
A60       @1 P
A61       @0 A
A64 01  1    @0 Vaccine
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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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Format Inist (serveur)

NO : PASCAL 14-0276947 INIST
ET : Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: A population-based study in Taiwan
AU : HUANG (Wan-Ting); TANG (Fa-Wei); YANG (Shu-Er); CHIH (Yi-Chien); CHUANG (Jen-Hsiang)
AF : Taiwan Centers for Disease Control, 6 Linsen S. Road/Taipei 10050/Taïwan (1 aut., 2 aut., 3 aut., 4 aut., 5 aut.); Institute of Biomedical Informatics & Institute of Public Health, National Yang-Ming University, 155 Section 2, Linong Street/Taipei 11221/Taïwan (5 aut.)
DT : Publication en série; Niveau analytique
SO : Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2014; Vol. 32; No. 48; Pp. 6463-6468; Bibl. 35 ref.
LA : Anglais
EA : 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.
CC : 002A05F04; 002A05C10
FD : Virus grippal A; Vaccination; Gestation; Taiwan; Adjuvant immunologique; Vaccin; Virus grippal A(H1N1)
FG : Influenzavirus A; Orthomyxoviridae; Virus; Asie; Extrême Orient; Zone subtropicale
ED : Influenza A virus; Vaccination; Pregnancy; Taiwan; Immunological adjuvant; Vaccine; Influenzavirus A(H1N1)
EG : Influenzavirus A; Orthomyxoviridae; Virus; Asia; Far east; Subtropical zone
SD : Influenza A virus; Vacunación; Gestación; Taiwan; Coadyuvante inmunológico; Vacuna
LO : INIST-20289.354000502696130230
ID : 14-0276947

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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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</fA64>
<fA66 i1="01">
<s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG">
<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>
</fC01>
<fC02 i1="01" i2="X">
<s0>002A05F04</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002A05C10</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<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>
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<fC03 i1="02" i2="X" l="FRE">
<s0>Vaccination</s0>
<s5>05</s5>
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<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>
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<fC03 i1="03" i2="X" l="FRE">
<s0>Gestation</s0>
<s5>06</s5>
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<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>
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<s0>Virus</s0>
<s2>NW</s2>
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<s0>Virus</s0>
<s2>NW</s2>
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<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>
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<fN82>
<s1>OTO</s1>
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<NO>PASCAL 14-0276947 INIST</NO>
<ET>Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: A population-based study in Taiwan</ET>
<AU>HUANG (Wan-Ting); TANG (Fa-Wei); YANG (Shu-Er); CHIH (Yi-Chien); CHUANG (Jen-Hsiang)</AU>
<AF>Taiwan Centers for Disease Control, 6 Linsen S. Road/Taipei 10050/Taïwan (1 aut., 2 aut., 3 aut., 4 aut., 5 aut.); Institute of Biomedical Informatics & Institute of Public Health, National Yang-Ming University, 155 Section 2, Linong Street/Taipei 11221/Taïwan (5 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2014; Vol. 32; No. 48; Pp. 6463-6468; Bibl. 35 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002A05F04; 002A05C10</CC>
<FD>Virus grippal A; Vaccination; Gestation; Taiwan; Adjuvant immunologique; Vaccin; Virus grippal A(H1N1)</FD>
<FG>Influenzavirus A; Orthomyxoviridae; Virus; Asie; Extrême Orient; Zone subtropicale</FG>
<ED>Influenza A virus; Vaccination; Pregnancy; Taiwan; Immunological adjuvant; Vaccine; Influenzavirus A(H1N1)</ED>
<EG>Influenzavirus A; Orthomyxoviridae; Virus; Asia; Far east; Subtropical zone</EG>
<SD>Influenza A virus; Vacunación; Gestación; Taiwan; Coadyuvante inmunológico; Vacuna</SD>
<LO>INIST-20289.354000502696130230</LO>
<ID>14-0276947</ID>
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