Study concept and design: Munoz, Ferreira, Baker.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Munoz, Bond, Jackson, Edwards, Ferreira, Baker.
Critical revision of the manuscript for important intellectual content: Munoz, Maccato, Pinell, Hammill, Swamy, Walter, Jackson, Englund, Healy, Petrie, Ferreira, Goll, Baker.
Statistical analysis: Munoz, Ferreira, Goll, Baker.
Obtained funding: Munoz, Walter, Englund.
Administrative, technical, or material support: Munoz, Bond, Maccato, Pinell, Hammill, Walter, Jackson, Englund, Edwards, Petrie, Baker.
Study supervision: Munoz, Walter, Jackson, Englund, Baker.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Munoz reported serving as a speaker for Sanofi Pasteur; serving as a consultant for Novartis, GlaxoSmithKline, and Novavax; and conducting clinical trials sponsored by Hoffmann-LaRoche, GlaxoSmithKline Biologicals, and Gilead Sciences. Dr Swamy reported receiving consulting and lecturing fees, grant support for vaccine-related studies, and payment for advisory board service, lectures, and development of educational presentations from GlaxoSmithKline; and receiving grant funding from GlaxoSmithKline specific to influenza vaccine and human papillomavirus infection. Dr Walter reported serving as a consultant and advisor for Merck; serving as a speaker for Sanofi Pasteur; and conducting clinical trials sponsored by GlaxoSmithKline, Merck, Novartis, and Pfizer. Dr Englund reported receiving research support from Novartis, Gilead, Chimerix, and Roche; serving as a consultant for GlaxoSmithKline in 2012-2013; serving on a GlaxoSmithKline data and safety monitoring board in 2012-13; and receiving travel expenses from Abbvie (part of Abbot) in 2013. Dr Edwards reported serving as consultant for and receiving grants from Novartis Vaccines. Dr Healy reported conducting trials with grants from Sanofi Pasteur and Novartis and serving as advisor for Novartis Vaccines. Dr Baker reported serving as consultant and advisory board member to Novartis Vaccines and as an advisory board member for Pfizer Inc. No other disclosures are reported.
Funding/Support: This study was supported by Division of Microbiology and Infectious Diseases Contracts N01AI80002C (Baylor College of Medicine, Houston, Texas), HHSN272200800004C (Group Health Research Institute, Seattle, Washington), and HHSN272200800057C (Duke University School of Medicine, Durham, North Carolina). Dr Englund was also supported in Seattle by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through grant UL1RR025014. Ms Petrie, Ms Ferreira, and Mr Goll performed this work supported by National Institute for Allergy and Infectious Diseases–Division of Microbiology and Infectious Diseases(DMID) contract (Clinical Research in Infectious Disease [CRID], HHSN272200800013C).
Role of the Sponsors: The National Institutes of Health and the DMID had a supervisory role in the design and conduct of the study but had no direct role in the collection, management, analysis, and interpretation of the data; the preparation, review, and approval of the manuscript; or the decision to submit the manuscript for publication.
Previous Presentation: Partial results of this study were presented by Dr Munoz at the Second International Neonatal and Maternal Immunization Meeting in Antalya, Turkey, March 3-5, 2013.
Additional Contributions: We gratefully acknowledge the women and infants who participated in this study, their obstetric and pediatric providers for contributing to the success of the trial, the physician assistants, nurses, coordinators, pharmacists, and administrative personnel at each of the participating Vaccine and Treatment Evaluation Units sites, the hospitals where study participants delivered, the members of the data and safety monitoring board and local safety monitors, and the team at National Institutes of Health/DMID and the EMMES Corporation (Gina Simone and Cyrille Amegashie) who supported this trial. We would also like to acknowledge W. Paul Glezen, MD, and Wendy A. Keitel, MD, from Baylor College of Medicine and Michael D. Decker, MD, MPH, David P. Greenberg, MD, and David R. Johnson, MD, MPH, from Sanofi Pasteur, for providing scientific guidance and expertise throughout the conduct of the study and manuscript preparation; Marcia A. Rench, BSN, Baylor College of Medicine, who assisted during the initial protocol design, and Susan Bobbitt, RN, study coordinator at the Baylor College of Medicine site. No compensation was received by any individual for assistance in the conduct of this study.