Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine and Commonly Administered Vaccines After

Roberto Gasparini1, Miguel Tregnaghi, Pavitra Keshavan

  • 1From the *Department of Health Sciences, University of Genoa, Genoa, Italy; †Department of Clinical Research Center Developing Advanced Projects (CEDEPAP), Córdoba, Argentina; ‡Global Clusters, Research and Development, Novartis Pharma BV, Amsterdam, The Netherlands; §Biostatistics and Statistical Reporting, Novartis Pharma BV, Amsterdam, The Netherlands; and ¶Global Clusters, Research and Development, Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts.

Insights

The quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) can be given with routine vaccines in all age groups. Coadministration showed no clinically relevant impact on immune responses, reactogenicity, or safety.

Area of Science:

  • Immunology
  • Vaccinology
  • Public Health

Background:

  • The quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) is used across a wide age range.
  • Evaluating coadministration with routine vaccines is crucial for safety and efficacy.

Purpose of the Study:

  • To assess the immunologic interference, reactogenicity, and safety of coadministering MenACWY-CRM with routine vaccines across different age groups.
  • To determine if coadministration impacts immune responses to MenACWY-CRM or other vaccines.

Main Methods:

  • Analysis of data from 10 Phase 3/4 clinical studies involving infants, adolescents, and international travelers.
  • Noninferiority analyses of immune responses to MenACWY-CRM and coadministered vaccines.
  • Assessment of reactogenicity and safety profiles following coadministration.

Main Results:

  • Coadministration of MenACWY-CRM with routine vaccines did not reduce immune responses to diphtheria, tetanus, poliovirus, hepatitis B, Hib, pneumococcal conjugate, MMR, varicella, or pertussis antigens in infants.
  • In adolescents, coadministration did not reduce immune responses to tetanus, diphtheria, or HPV vaccine antigens.
  • Immune responses to MenACWY-CRM were not affected by coadministration, and no increased adverse events were observed in any age group.

Conclusions:

  • Coadministration of MenACWY-CRM with routine vaccines is supported across all age groups.
  • No clinically relevant vaccine interactions or adverse effects on reactogenicity or safety were identified.
  • These findings support the integrated vaccination schedules for improved public health outcomes.
Abstract

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