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. 2014 May 5;59(4):560–568. doi: 10.1093/cid/ciu327

Table 2.

Studies Reporting Birth Outcomes With Trivalent Inactivated or H1N1 Influenza Vaccine Administered During Pregnancy

First Author Site Trial Design Intervention Control Risk of Preterm Birth (95% CI) Risk of Low Birth Weight (95% CI) Risk of Small for Gestational Age (95% CI)
Omer, 2011 [27] Georgia, USA Retrospective cohort analysis TIV
N = 578
No vaccine
N = 3748
OR: 0.28 (.11–.74) OR: 0.31 (.13–.75)
Steinhoff, 2012 [28] Dhaka, Bangladesh Randomized controlled clinical trial TIV
N = 172
Pneumococcal polysaccharide vaccine
N = 168
OR: 0.48 (.08–2.74) OR: 0.19 (.02–1.64) OR: 0.43 (.20–.94)
Kallen, 2012 [29] Sweden Retrospective population-based cohort analysis H1N1 vaccine
N = 18 612
No vaccine
N = 136 914
OR: 0.86 (.77–.96) OR: 0.86 (.77–.96) OR: 1.04 (.92–1.17)
Fell, 2012 [30] Ontario, Canada Retrospective population-based cohort analysis H1N1 vaccine
N = 23 340
No vaccine
N = 32 230
RR: 0.73 (.58–.91) RR 0.90 (.85–.96)
Pasternak, 2012 [24] Denmark Retrospective population-based cohort study H1N1 vaccine
N = 6989 infants
No vaccine
N = 46 443 infants
1st trimester:
OR: 1.32 (.76–2.31)
2nd/3rd trimester:
OR: 1.00 (.84–1.17)
1st trimester:
OR: 0.83 (.41–1.67)
2nd/3rd trimester:
OR: 1.14 (.94–1.38)
1st trimester: OR: 0.79 (.46–1.37); 2nd/3rd trimester: OR: 0.97 (.87–1.09)
Richards, 2013 [31] Georgia, USA Retrospective cohort analysis H1N1 vaccine
N = 1125
No vaccine
N = 1581
OR: 0.63 (.47–.84) OR: 0.79 (.56–1.10) OR: 1.26 (.94–1.69)

Adapted from Steinhoff and Omer [26].

Abbreviations: CI, confidence interval; OR, odds ratio; RR, relative risk; TIV, trivalent inactivated influenza vaccine.