Table 2.
Characteristics of selected studies.
| Study authorand year [reference] | Continent | Study design | Type of vaccine | Primary study outcome | Safety-related outcome (if different from primary outcome) |
|---|---|---|---|---|---|
| Abzug, 2013 [28] | North America | Prospective cohort | Influenza | Safety and immunogenicity of H1N1 vaccine in HIV infected pregnant women | |
| Adedinsewo, 2013 [29] | North America | Retrospective cohort | Influenza | Maternal vaccination impact on prematurity and SGA | |
| Auffret, 2013 [30] | Europe | Prospective cohort | Influenza | Adverse event and vaccine safety of influenza vaccine in pregnant women | |
| Baker, 1988 [31] | North America | Prospective cohort | GBS | Antibody level in immunized pregnancies and in newborns | Maternal adverse effects |
| Baker, 2003 [32] | North America | RCT | GBS | Safety and immunogenicity in pregnant women | Maternal adverse effects |
| Bednarczyk, 2012† [12] | Multiple | Review | Influenza | Safety of influenza immunization for fetus and neonate | |
| Black, 2004 [33] | North America | Retrospective cohort | Influenza | Impact of influenza vaccination on pregnant women and risk of illness and safety in newborns | |
| Cantu, 2013 [34] | North America | Retrospective cohort | Influenza | Association of influenza vaccination with increased risk of adverse pregnancy outcomes | |
| Cavalcanti, 2007 [35] | South America | Before/after | Yellow fever | Effect of yellow fever vaccine on newborn malformation rates | |
| Chambers, 2013 [36] | North America | Prospective cohort | Influenza | Risk and safety of H1N1 vaccines in women exposed during pregnancy | |
| Chavant, 2013 [37] | Europe | Prospective cohort | Influenza | Safety of a/H1N1 vaccination during pregnancy | |
| Christian, 2011 [38] | North America | Prospective cohort | Influenza | Inflammatory response to vaccination in pregnant women | |
| Conlin, 2013 [39] | North America | Retrospective cohort | Influenza | Safety of H1N1 vaccine in Pregnant US military women | |
| Cottin, 2013† [40] | Multiple | Review | Yellow fever | Adverse events from yellow fever vaccine | |
| da Silva, 2011 [41] | South America | Prospective cohort | Rubella | Safety of Rubella vaccine during pregnancy | |
| Dana, 2009 [42] | Multiple | Prospective cohort | HPV | Safety of HPV vaccine during pregnancy-pregnancy outcomes and birth defects | |
| De Vries, 2014 [43] | Europe | Prospective cohort | Influenza | Adverse events of adjuvanted a/H1N1 vaccination during pregnancy | |
| Ergenoglu, 2012 [44] | Europe | Prospective cohort | Rubella | Safety of Rubella vaccine during pregnancy | |
| Harjulehto-Mervaala, 1994 [45] | Europe | Prospective cohort | OPV | Fetal development and perinatal outcome after OPV vaccination during pregnancy | |
| Hashim, 2012* [18] | Africa | Cross-sectional | Cholera | Birth outcomes between exposed and unexposed pregnancies | |
| Heikkinen, 2012 [24] | Multiple | Prospective cohort | Influenza | Influenza vaccine safety in pregnant women and neonates | |
| Huang, 2013 [46] | Asia | Prospective cohort | Rabies | Safety of post-exposure prophylaxis during pregnancy | |
| Kallen, 2012 [47] | Europe | Retrospective cohort (registry data) | Influenza | Pregnancy outcomes post H1N1 vaccination | |
| Kharbanda, 2012 [48] | North America | Prospective cohort | Influenza | Adverse effects from trivalent or monovalent influenza vaccination during pregnancy | |
| Kharbanda, 2013 [49] | North America | Retrospective cohort | Influenza | Adverse events between exposed and unexposed pregnant women, specifically, preterm and small for gestational age births | |
| Launay, 2012 [50] | Europe | Prospective cohort | Influenza | Consequences of maternal vaccination on pregnancy outcomes and maternal seroprotection at delivery | |
| Lehmann, 2003*† [19] | Asia | Review | Pneumococcal | Pneumococcal vaccine safety review | |
| Lin, 2012 [51] | Asia | Retrospective cohort | Influenza | Adverse events after AdimFlu-S vaccination in pregnant women | |
| Lin, 2013 [52] | Asia | Prospective cohort | Influenza | Immune response of the three vaccine viral strains | Incidence of pre-specified adverse events and all serious/non-serious adverse events |
| Louik, 2013 [53] | North America | Prospective cohort | Influenza | Safety of H1N1 vaccine during pregnancy | |
| Ludvigsson, 2013 [54] | Europe | Retrospective cohort | Influenza | Adverse pregnancy outcomes from influenza H1N1 vaccination | |
| Mackenzie, 2012 [55] | Europe | Prospective cohort | Influenza | Adverse events and pregnancy outcome post H1N1 vaccination | |
| Makris, 2012† [56] | Multiple | Review | Multiple | Safety of various maternal vaccines | |
| Moro, 2011 [57] | North America | Retrospective cohort | Influenza (monovalent) | Adverse events of monovalent influenza vaccination during pregnancy | |
| Moro, 2011 [58] | North America | Retrospective cohort | Influenza (trivalent) | Adverse events of influenza vaccine between exposed and unexposed pregnancies | |
| Moro, 2012† [59] | Multiple | Review | Influenza | Safety of influenza vaccines on pregnant women and neonates with emphasis on a/H1N1 monovalent vaccine | |
| Moro, 2013 [60] | North America | Retrospective cohort | Influenza | Maternal and infant outcomes for vaccinated pregnant women | |
| Moro, 2014 [61] | North America | Retrospective cohort | Hepatitis | Vaccine maternal adverse effects | |
| Munoz, 2001 [7] | North America | RCT | Multiple | Safety and immunogenicity of PSV in pregnant women | |
| Munoz, 2003 [62] | North America | RCT | RSV | Safety and immunogenicity of RSV vaccine during pregnancy | |
| Munoz, 2005 [63] | North America | Retrospective cohort | Influenza | Safety of influenza vaccination during pregnancy | |
| Munoz, 2014 [64] | North America | RCT | Tdap | Safety of Tdap vaccine during pregnancy | Infant response to DTaP vaccine |
| Naleway, 2014† [65] | North America | Review | Influenza | Safety of influenza vaccination during pregnancy | |
| Nishioka, 1998 [23] | South America | Case control | Yellow fever | Effect of yellow fever vaccination on spontaneous abortion | |
| Nordin, 2013 [66] | North America | Retrospective cohort | Influenza | Adverse Events after first trimester influenza vaccination | |
| Nordin, 2014 [67] | North America | Retrospective cohort | Influenza | Impact of influenza vaccine on preterm and SGA | |
| Omon, 2011 [68] | Europe | Prospective cohort | Influenza | Safety of non-adjuvanted H1N1 vaccine on pregnant women | |
| Oppermann, 2012 [69] | Europe | Prospective cohort | Influenza | H1N1 vaccine safety in pregnancy | |
| Orenstein, 2012*† [20] | Africa | Review | Multiple | Develop estimates of maternal and neonatal background morbidity and mortality | |
| Pardon, 2011 [70] | South America | Prospective cohort | Rubella | Fetal adverse events after rubella vaccination in pregnant women | |
| Pass, 2009 [71] | North America | RCT | CMV | CMV infection | Vaccine adverse effects and birth outcomes |
| Pasternak, 2012 [22] | Europe | Retrospective cohort (registry data) | Influenza | a/H1N1 vaccination association with major birth defects, preterm birth and fetal growth restriction | |
| Pasternak, 2012 [72] | Europe | Retrospective cohort (registry data) | Influenza | Risk of fetal death and spontaneous abortion from vaccination against a/H1N1 | |
| Pitisuttithum, 2011 [73] | Asia | RCT | HIV | Adverse events related and unrelated to pregnancy | |
| Quiambao, 2007* [21] | Asia | RCT | Pneumococcal | Immunogenicity and antibody transfer after pneumococcal vaccination | |
| Santosham, 2001 [74] | North America | RCT | Multiple | Safety and immunogenicity of Hib vaccines verses pneumococcal | |
| Sato, 2011 [75] | South America | Prospective cohort | Rubella | Fetal adverse events after rubella vaccination in pregnant women | Congenital rubella infection in newborns after exposure to vaccine |
| Shakib, 2013 [76] | North America | Retrospective cohort | Tdap | Safety of Tdap vaccine during pregnancy | |
| Sheffield, 2011 [77] | North America | Prospective cohort | Hepatitis | Feasibility and immunogenicity of an accelerated hepatitis B vaccine schedule in high-risk pregnant women | Maternal adverse effects |
| Sheffield, 2012 [78] | North America | Retrospective cohort | Influenza | First trimester influenza vaccination on neonatal outcomes | |
| Sheffield, 2013† [79] | Multiple | Review | Multiple | Standardized vital signs and laboratory assessments during maternal vaccine trials | |
| Silveira, 1995 [80] | South America | Case control | TT | Safety outcomes of TT in newborns | |
| Suzano, 2006 [81] | South America | Retrospective cohort | Yellow fever | Safety of yellow fever during pregnancy | |
| Talbot, 2010 [82] | North America | Cross-sectional | Tdap | Safety of Tdap less than 2 year after previous tetanus vaccination | |
| Tavares, 2011 [83] | Europe | Prospective cohort | Influenza | Safety outcomes in exposed and unexposed women | |
| Tavares, 2013† [84] | Multiple | Review | Herpes simplex | Risk of spontaneous abortion following HSV vaccination | |
| Thomas, 2012† [85] | Multiple | Review | Yellow fever | Adverse events from yellow fever vaccine in vulnerable populations | |
| Toback, 2012 [86] | North America | Retrospective cohort | Influenza | Safety of LAIV during pregnancy | |
| Tsai, 2010 [87] | Europe | Retrospective cohort | Influenza | Pregnancy outcomes in exposed and unexposed women | |
| Wilson, 2008 [88] | North America | Retrospective cohort (registry data) | Varicella | Outcomes after inadvertent exposure to Varicella vaccine during pregnancy | |
| Wise, 2000 [89] | North America | Retrospective cohort | Varicella | Adverse events from varicella vaccine | |
| Wright, 1999 [90] | North America | RCT | HIV | Safety of rgp120 during pregnancy | |
| Zheteyeva, 2012 [91] | North America | Retrospective cohort | Tdap | Safety of Tdap in pregnant women | |
| Zheteyeva, 2013 [92] | North America | Retrospective cohort | Meningococcal | Safety of meningococcal vaccine in pregnancy | |
*
Study conducted in lower- or lower-middle-income country.
†
Systematic review.