Background: Although the meningococcal conjugate MenACWY-CRM vaccine is not approved for use in pregnant women, unintentional exposure during pregnancy can occur, especially during early pregnancy among women of child-bearing age. This study provides safety information about inadvertent MenACWY-CRM vaccination during pregnancy.
Methods: The evaluated population consisted of pregnant female members of Kaiser Permanente Southern California who inadvertently received MenACWY-CRM at 11-21 years of age during 09/30/2011-06/30/2013 within 28 days prior to conception or during pregnancy. Chart abstraction was conducted to identify pregnancy and birth outcomes, including spontaneous and induced abortions, preterm births, low weight births, and major congenital malformations (MCMs).
Results: There were 92 women who received MenACWY-CRM during the pregnancy exposure period, mainly during the first trimester (76.1%). Hispanics represented the largest race/ethnicity category (68.5%). Among the known pregnancy outcomes (n = 66; excluding induced abortions and unknown pregnancy outcomes), the prevalence of spontaneous abortions was 18.2% (n = 12). Among live born infants (n = 55; from 54 pregnancies), 14.5% (n = 8) were born preterm (<37 weeks gestation) and 9.1% (n = 5) had a low birthweight (<2500 g). The prevalence rate of MCMs among live born infants (n = 55) was 1.8% (n = 1).
Conclusions: This study provides baseline prevalence estimates of spontaneous abortions, preterm births, low weight births, and MCMs among women inadvertently exposed to MenACWY-CRM during the pregnancy period. These estimates appear to be comparable with U.S. background prevalence estimates.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.vaccine.2020.02.008 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Background: A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the five meningococcal serogroups that cause most invasive disease cases.
Methods: In this phase 3 study (NCT04707391), healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive two MenABCWY doses six months apart or one MenACWY-CRM dose. Primary objectives were to demonstrate the non-inferiority of MenABCWY 1 month post-vaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety.
Impact on meningococcal disease of different vaccination strategies with 4CMenB and MenACWY-CRM197 in infants and adolescents in Argentina.
Vaccine
January 2025
GSK, Emerging Markets, Santiago, Chile.
Background: Invasive meningococcal disease (IMD) is a life-threatening disease, primarily affecting infants and children. Argentina introduced routine meningococcal vaccination in infants and adolescents in 2017, with MenACWY vaccination targeting serogroups A, C, W, and Y (current National Immunization Program [cNIP]). Serogroup B, more prevalent since 2015, became predominant in children.
View Article and Find Full Text PDF4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults.
Open Forum Infect Dis
November 2024
GSK, Siena, Italy.
Article Synopsis
- Meningococcal serogroup B (MenB) vaccination with the 4CMenB vaccine was tested for its effectiveness and safety among 3,651 healthy participants aged 10 to 25, using different dosing schedules (0-2, 0-6, and 0-2-6 months).
- The study measured the immune response through two methods: a test-based approach showing high immune breadth (over 78%) and a responder-based approach indicating a significant percentage of participants achieved strong responses (up to 93.4% for the 0-2-6 schedule).
- The results showed no major differences in effectiveness across the dosing schedules, confirming that the simpler 2-dose regimen (0-2)
Introduction: The currently licensed quadrivalent MenACWY-CRM conjugate vaccine presentation consists of two vials (lyophilized MenA and liquid MenCWY) to be reconstituted before injection. A new fully liquid, single-vial formulation has been developed to simplify administration and prevent reconstitution errors. We present pooled safety data from two randomized, controlled, observer-blind phase 2b clinical trials, in which the fully liquid presentation was compared with the licensed presentation.
View Article and Find Full Text PDFImpact of an adolescent meningococcal ACWY immunisation programme to control a national outbreak of group W meningococcal disease in England: a national surveillance and modelling study.
Lancet Child Adolesc Health
February 2022
Immunisation and Countermeasures Division, Public Health England, Colindale, London, UK; Paediatric Infectious Diseases Research Group, St George's University of London, London, UK. Electronic address:
Background: In August, 2015, the UK implemented an emergency adolescent immunisation programme with the meningococcal ACWY conjugate vaccine to combat a national outbreak of meningococcal group W (MenW) disease due to a hypervirulent ST-11 complex strain, which is currently causing regional and national outbreaks worldwide. This immunisation programme specifically targeted adolescents aged 13-18 years, an age group with low disease incidence but high nasopharyngeal carriage, with the aim of interrupting transmission and providing indirect (herd) protection across the population. Here, we report the impact of the first 4 years of the programme in England.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!