Assessment of safety in newborns of mothers participating in clinical trials of vaccines administered during pregnancy.

A panel of experts convened by the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, developed proposed guidelines for the evaluation of adverse events in newborns of women participating in clinical trials of maternal immunization in the United States.

[1]  S. Hernández-Díaz,et al.  Assessment of congenital anomalies in infants born to pregnant women enrolled in clinical trials. , 2014, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[2]  Johannes B. Goll,et al.  Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. , 2014, JAMA.

[3]  M. Decker,et al.  Immune Responses in Infants Whose Mothers Received Tdap Vaccine During Pregnancy , 2013, The Pediatric infectious disease journal.

[4]  S. Rasmussen,et al.  Research on vaccines during pregnancy: protocol design and assessment of safety. , 2013, Vaccine.

[5]  S. Rasmussen,et al.  Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments. , 2013, Vaccine.

[6]  R. Rappuoli,et al.  Preventing Newborn Infection with Maternal Immunization , 2013, Science Translational Medicine.

[7]  B. Lindsey,et al.  Maternal immunization as a strategy to decrease susceptibility to infection in newborn infants , 2013, Current opinion in infectious diseases.

[8]  S. Hugonnet,et al.  Priorities for research on meningococcal disease and the impact of serogroup A vaccination in the African meningitis belt. , 2013, Vaccine.

[9]  M. Sawyer,et al.  Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012 , 2013, MMWR. Morbidity and mortality weekly report.

[10]  M. Trautman,et al.  A Randomized Study of a Monoclonal Antibody (Pagibaximab) to Prevent Staphylococcal Sepsis , 2011, Pediatrics.

[11]  Reese H Clark,et al.  New Intrauterine Growth Curves Based on United States Data , 2010, Pediatrics.

[12]  L. Vernacchio,et al.  Management of Acute Otitis Media After Publication of the 2004 AAP and AAFP Clinical Practice Guideline , 2010, Pediatrics.

[13]  G. Fischer,et al.  Phase 1/2 Double-Blind, Placebo-Controlled, Dose Escalation, Safety, and Pharmacokinetic Study of Pagibaximab (BSYX-A110), an Antistaphylococcal Monoclonal Antibody for the Prevention of Staphylococcal Bloodstream Infections, in Very-Low-Birth-Weight Neonates , 2009, Antimicrobial Agents and Chemotherapy.

[14]  Robert T. Chen,et al.  Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems. , 2009, Vaccine.

[15]  C. Baker,et al.  Immunization of pregnant women with group B streptococcal type III capsular polysaccharide-tetanus toxoid conjugate vaccine. , 2003, Vaccine.

[16]  P. Piedra,et al.  Safety and immunogenicity of respiratory syncytial virus purified fusion protein-2 vaccine in pregnant women. , 2003, Vaccine.

[17]  Newborn.  Apnea, Sudden Infant Death Syndrome, and Home Monitoring , 2003 .

[18]  S. Rasmussen,et al.  Guidelines for case classification for the National Birth Defects Prevention Study. , 2003, Birth defects research. Part A, Clinical and molecular teratology.

[19]  L. Wright,et al.  NICHD Neonatal Research Network , 2002 .

[20]  V. Bhutani,et al.  Predictive Ability of a Predischarge Hour-specific Serum Bilirubin for Subsequent Significant Hyperbilirubinemia in Healthy Term and Near-term Newborns , 1999, Pediatrics.

[21]  D. McMillan,et al.  Approach to the bleeding newborn. , 1998, Paediatrics & child health.

[22]  M. Andrew,et al.  The relevance of developmental hemostasis to hemorrhagic disorders of newborns. , 1997, Seminars in perinatology.

[23]  M. Cornblath,et al.  American Academy of Pediatrics. Committee on fetus and newborn. Nomenclature for duration of gestation, birth weight and intra-uterine growth. , 1967, Pediatrics.

[24]  T. Wardlaw,et al.  Low birthweight: country regional and global estimates. , 2004 .

[25]  Boscoe M. Paes,et al.  Development of the Hemostatic System in the Neonate and Young Infant , 1990, The American journal of pediatric hematology/oncology.