| Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. | |
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MedLine Citation:
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PMID: 19935017 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To present a combined analysis of the pregnancy outcomes for women aged up to 45 years enrolled in five phase III clinical studies of the prophylactic quadrivalent human papillomavirus 6/11/16/18 vaccine. METHODS: Twenty thousand five hundred fifty-one women aged 15-45 years received quadrivalent HPV vaccine or placebo at day 1 and months 2 and 6. Urine pregnancy tests were performed immediately before each injection; participants testing positive were not vaccinated. Women who became pregnant after enrollment were discontinued from further vaccination until resolution of pregnancy. All pregnancies were followed for outcomes. RESULTS: During the studies, 1,796 vaccine and 1,824 placebo recipients became pregnant, resulting in 2,008 and 2,029 pregnancies with known outcomes. No significant differences were noted overall for the proportions of pregnancies resulting in live birth, fetal loss, or spontaneous abortion. A total of 40 neonates born to vaccinated women and 30 neonates born to women given placebo had one or more congenital anomalies (P=.20). The anomalies were diverse and consistent with those most commonly observed in the general population. The vaccine was well tolerated among women who became pregnant. CONCLUSION: Administration of quadrivalent human papillomavirus vaccine to women who became pregnant during the phase III clinical trials did not appear to negatively affect pregnancy outcomes. The vaccine is a U.S. Food and Drug Administration pregnancy category B medication (animal studies revealed no evidence of fetal harm, but there are no adequate and well-controlled studies in pregnant women); however, vaccination is not recommended during pregnancy. Postlicensure surveillance is ongoing. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00092521, NCT00092534, NCT00092495, NCT00092547 and NCT00090220. LEVEL OF EVIDENCE: II. |
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Authors:
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Suzanne M Garland; Kevin A Ault; Stanley A Gall; Jorma Paavonen; Heather L Sings; Karen L Ciprero; Alfred Saah; Deborah Marino; Desmond Ryan; David Radley; Haiping Zhou; Richard M Haupt; Elizabeth I O Garner; |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Obstetrics and gynecology Volume: 114 ISSN: 1873-233X ISO Abbreviation: Obstet Gynecol Publication Date: 2009 Dec |
Date Detail:
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Created Date: 2009-11-25 Completed Date: 2009-12-21 Revised Date: 2010-06-08 |
Medline Journal Info:
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Nlm Unique ID: 0401101 Medline TA: Obstet Gynecol Country: United States |
Other Details:
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Languages: eng Pagination: 1179-88 Citation Subset: AIM; IM |
Affiliation:
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Microbiology and Infectious Diseases Department, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00090220; NCT00092495; NCT00092521; NCT00092534; NCT00092547 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Clinical Trials, Phase III as Topic Female Humans Infant, Newborn Infant, Newborn, Diseases / chemically induced* Lactation Middle Aged Papillomavirus Vaccines / administration & dosage, adverse effects* Pregnancy Pregnancy Outcome* Randomized Controlled Trials as Topic Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Papillomavirus Vaccines; 0/human papillomavirus vaccine L1, type 6,11,16,18 |
| Comments/Corrections | |
Comment In:
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Obstet Gynecol. 2009 Dec;114(6):1168-9
[PMID:
19935015
]
Evid Based Med. 2010 Jun;15(3):80-1 [PMID: 20522684 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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