TY - JOUR
T1 - Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18
T2 - Pooled analysis of two randomised controlled trials
AU - Wacholder, Sholom
AU - Chen, Bingshu Eric
AU - Wilcox, Allen
AU - Macones, George
AU - Gonzalez, Paula
AU - Befano, Brian
AU - Hildesheim, Allan
AU - Rodríguez, Ana Cecilia
AU - Solomon, Diane
AU - Herrero, Rolando
AU - Schiffman, Mark
PY - 2010/3/27
Y1 - 2010/3/27
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=77950258317&partnerID=8YFLogxK
U2 - 10.1136/bmj.c712
DO - 10.1136/bmj.c712
M3 - Article
C2 - 20197322
AN - SCOPUS:77950258317
VL - 340
SP - 696
JO - British Medical Journal
JF - British Medical Journal
SN - 0959-8146
IS - 7748
M1 - c712
ER -