Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials

[Guest guest]

As a ,"multiple miscarrier", I cannot understand any woman who risks vaccine damage while pregnant. You'er not just playing with your life.

Sue

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Published 2 March 2010, doi:10.1136/bmj.c712Cite this as: BMJ 2010;340:c712

Research

Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials

Sholom Wacholder, study statistician and principal investigator1, Bingshu Chen, assistant professor2, Wilcox, senior investigator3, Macones, professor of obstetrics and gynaecology4, a , study co-investigator5, Befano, senior programmer6, Allan Hildesheim, study investigator, principal investigator1, Ana Cecilia Rodríguez, study co-investigator5, Diane , study co-investigator7, Rolando Herrero, study principal investigator5, Mark Schiffman, study co-investigator, senior investigator1, for the CVT group

1 Division of Cancer Epidemiology and Genetics, National Cancer Institute, 6120 Executive Blvd, Rockville, MD 20852, USA, 2 NCIC Clinical Trials Group, Queen’s University, 10 Stuart Street, Kingston, Ontario, Canada K7L 3N6, 3 National Institute of Environmental Health Sciences, Division of Intramural Research, PO Box 12233, Research Triangle Park, NC 27709, USA, 4 Department of Obstetrics and Gynecology, Washington University, Campus Box 8064, St Louis, MO 63130 USA, 5 Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Torre La Sabana, Piso 7, Sabana Norte, San José, Costa Rica, 6 Information Management Services, 12501 Prosperity Dr, Suite 200, Silver Spring, MD 20904, USA, 7 Division of Cancer Prevention, National Cancer Institute, Rockville, MD 20852, USA

Correspondence to: S Wacholder WacholdS@...

Objective To assess whether vaccination against human papillomavirus (HPV) increases the risk of miscarriage.

Design Pooled analysis of two multicentre, phase three masked randomised controlled trials

Setting Multicentre trials in several continents and in Costa Rica.

Participants 26 130 women aged 15-25 at enrolment; 3599 pregnancies eligible for analysis.

Interventions Participants were randomly assigned to receive three doses of bivalent HPV 16/18 VLP vaccine with AS04 adjuvant (n=13 075) or hepatitis A vaccine as control (n=13 055) over six months.

Main outcome measures Miscarriage and other pregnancy outcomes.

Results The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination.

Conclusion There is no evidence overall for an association between HPV vaccination and risk of miscarriage.

Trial registration Clinical Trials NCT00128661 [ClinicalTrials.gov] and NCT00122681 [ClinicalTrials.gov] .

© Wacholder et al 2010This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.