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You are here: Home / NEWS . . . . . . . . / Vaccines / HPV / Cervarix / Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18

Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18

January 16, 2011 By Norma

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

  • Accepted 26 October 2009

    Abstract

    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 and NCT00122681.

    Access the entire study here.

    Related

    Filed Under: Cervarix, Cervarix Clinical Trials, Cervarix Reactions Tagged With: bivalent, HPV types 16 and 18, HPV vaccine, immunization, risks

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    HPV Vaccine VAERS Reports

    Description 12/14/2019  TOTAL
    Disabled 3,092
    Deaths 523
    Did Not Recover 13,072
    Abnormal Smear 695
    Cervical Cancer 186
    Infertility 52
    Life-threatening 1,001
    Emergency Room 15,419
    Hospitalized 6,448
    Extended Hosp. Stay 304
    Serious 9,497
    Total Adverse Events 64,270

    Access expanded report here.

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