Literature DB >> 25425720

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

Flor M Munoz1, Leonard E Weisman2, Jennifer S Read3, George Siberry4, Karen Kotloff5, Jennifer Friedman6, Rosemary D Higgins7, Heather Hill8, Harry Seifert9, Mirjana Nesin10.   

Abstract

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.
© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Entities:  

Keywords:  clinical trials; maternal immunization; safety; pregnancy; vaccines

Mesh：

Substances：

Year:  2014        PMID： 25425720      PMCID： PMC4303057          DOI： 10.1093/cid/ciu727

Source DB:  PubMed          Journal:  Clin Infect Dis        ISSN： 1058-4838            Impact factor:   9.079


  23 in total

1.  Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems.

Authors:  Jan Bonhoeffer; Adwoa Bentsi-Enchill; Robert T Chen; Margaret C Fisher; Michael S Gold; Katharina Hartman; Ulrich Heininger; Bernard Hoet; Thomas Jefferson; Najwa Khuri-Bulos; Katrin Kohl; S Michael Marcy; David Nalin; Robert Pless; Hernan Sanabria-Rojas; Karen Sleeman; Robert Wise
Journal:  Vaccine       Date:  2008-12-04       Impact factor: 3.641

2.  17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm.

Authors:  William A Grobman; Elizabeth A Thom; Catherine Y Spong; Jay D Iams; George R Saade; Brian M Mercer; Alan T N Tita; Dwight J Rouse; Yoram Sorokin; Ronald J Wapner; Kenneth J Leveno; Sean Blackwell; M Sean Esplin; Jorge E Tolosa; John M Thorp; Steve N Caritis; J Peter Van Dorsten
Journal:  Am J Obstet Gynecol       Date:  2012-09-17       Impact factor: 8.661

3.  Priorities for research on meningococcal disease and the impact of serogroup A vaccination in the African meningitis belt.

Authors:  Danny Altmann; Abraham Aseffa; Margaret Bash; Nicole Basta; Ray Borrow; Claire Broome; Dominique Caugant; Tom Clark; Jean-Marc Collard; Mamoudou Djingarey; David Goldblatt; Brian Greenwood; Ulla Griffiths; Rana Hajjeh; Musa Hassan-King; Stephane Hugonnet; Ann Marie Kimball; Marc LaForce; Calman MacLennan; Martin C J Maiden; Olivier Manigart; Leonard Mayer; Nancy Messonnier; Jennifer Moisi; Katie Moore; Daugla Doumagoum Moto; Judith Mueller; Maria Nascimento; Stephen Obaro; Rasmata Ouedraogo; Anne-Laure Page; Willima Perea; Gerd Pluschke; Mari-Pierre Preziosi; Samba Sow; David Stephens; James Stuart; Madeleiene Thomson; Sylvestre Tiendrebeogo; Jean-Francois Trape; Guy Vernet
Journal:  Vaccine       Date:  2012-12-27       Impact factor: 3.641

4.  Immune responses in infants whose mothers received Tdap vaccine during pregnancy.

Authors:  Abbey J Hardy-Fairbanks; Stephanie J Pan; Michael D Decker; David R Johnson; David P Greenberg; Kathryn B Kirkland; Elizabeth A Talbot; Henry H Bernstein
Journal:  Pediatr Infect Dis J       Date:  2013-11       Impact factor: 2.129

Review 5.  Development of the hemostatic system in the neonate and young infant.

Authors:  M Andrew; B Paes; M Johnston
Journal:  Am J Pediatr Hematol Oncol       Date:  1990

6.  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.

Authors:  Leonard E Weisman; Helen M Thackray; Joseph A Garcia-Prats; Mirjana Nesin; Joseph H Schneider; Jennifer Fretz; John F Kokai-Kun; James J Mond; William G Kramer; Gerald W Fischer
Journal:  Antimicrob Agents Chemother       Date:  2009-04-20       Impact factor: 5.191

7.  ACOG Committee Opinion No. 566: Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination.

Authors: 
Journal:  Obstet Gynecol       Date:  2013-06       Impact factor: 7.661

8.  Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns.

Authors:  V K Bhutani; L Johnson; E M Sivieri
Journal:  Pediatrics       Date:  1999-01       Impact factor: 7.124

9.  New intrauterine growth curves based on United States data.

Authors:  Irene E Olsen; Sue A Groveman; M Louise Lawson; Reese H Clark; Babette S Zemel
Journal:  Pediatrics       Date:  2010-01-25       Impact factor: 7.124

10.  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.

Authors: 
Journal:  MMWR Morb Mortal Wkly Rep       Date:  2013-02-22       Impact factor: 17.586
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  6 in total

1.  Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

Authors:  Christine E Jones; Flor M Munoz; Hans M L Spiegel; Ulrich Heininger; Patrick L F Zuber; Kathryn M Edwards; Philipp Lambach; Pieter Neels; Katrin S Kohl; Jane Gidudu; Steven Hirschfeld; James M Oleske; Najwa Khuri-Bulos; Jorgen Bauwens; Linda O Eckert; Sonali Kochhar; Jan Bonhoeffer; Paul T Heath
Journal:  Vaccine       Date:  2016-07-29       Impact factor: 3.641

2.  Safety, immunogenicity, and transplacental antibody transport of conjugated and polysaccharide pneumococcal vaccines administered to pregnant women with HIV: a multicentre randomised controlled trial.

Authors:  Adriana Weinberg; Petronella Muresan; Lauren Laimon; Stephen I Pelton; David Goldblatt; Jennifer Canniff; Bonnie Zimmer; Frederic Bone; Lassallete Newton; Terence Fenton; James Kiely; Michael J Johnson; Esau C Joao; Breno R Santos; Elizabeth S Machado; Jorge A Pinto; Nahida Chakhtoura; Geraldo Duarte; Marisa M Mussi-Pinhata
Journal:  Lancet HIV       Date:  2021-04-27       Impact factor: 16.070

Review 3.  Moving targets: The challenges of studying infectious diseases among pregnant women in resource limited settings.

Authors:  Titus H Divala; Randy G Mungwira; Miriam K Laufer
Journal:  Vaccine       Date:  2015-08-25       Impact factor: 3.641

Review 4.  Key terms for the assessment of the safety of vaccines in pregnancy: Results of a global consultative process to initiate harmonization of adverse event definitions.

Authors:  Flor M Munoz; Linda O Eckert; Mark A Katz; Philipp Lambach; Justin R Ortiz; Jorgen Bauwens; Jan Bonhoeffer
Journal:  Vaccine       Date:  2015-09-19       Impact factor: 3.641

Review 5.  A systematic review of adverse events following immunization during pregnancy and the newborn period.

Authors:  T Roice Fulton; Divya Narayanan; Jan Bonhoeffer; Justin R Ortiz; Philipp Lambach; Saad B Omer
Journal:  Vaccine       Date:  2015-09-26       Impact factor: 3.641

6.  Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

Authors:  Jayani Pathirana; Flor M Muñoz; Victoria Abbing-Karahagopian; Niranjan Bhat; Tara Harris; Ambujam Kapoor; Daniel L Keene; Alexandra Mangili; Michael A Padula; Stephen L Pande; Vitali Pool; Farshad Pourmalek; Frederick Varricchio; Sonali Kochhar; Clare L Cutland
Journal:  Vaccine       Date:  2016-07-19       Impact factor: 3.641
  6 in total

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