AI Article Synopsis
- This phase 3 study evaluated the safety and effectiveness of the MenACWY-CRM vaccine, aiming for approval in India, involving 180 healthy participants aged 2-75 years.
- Participants received one dose of the vaccine, and immune responses were measured before and after vaccination; adverse events were also monitored throughout the study period.
- Results showed a strong immune response in all age groups, with high percentages achieving protective levels against the four serogroups, and the vaccine was reported to be well tolerated with no major safety issues.
Article Abstract
Background: This phase 3, multi-center, open-label study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo(®); Novartis Vaccines and Diagnostics S.r.l., Siena, Italy) in healthy Indian subjects aged 2-75 years, to provide data for licensure in India.
Methods: A total of 180 subjects were enrolled (60 subjects 2-10 years, 60 subjects 11-18 years, and 60 subjects 19-75 years) and received one dose of MenACWY-CRM. Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination. Adverse events were collected throughout the 29-day study period.
Results: Percentages of subjects with post-vaccination hSBA ≥8 were 72%, 95%, 94%, and 90% for serogroups A, C, W, and Y, respectively. Geometric mean titers rose 7-fold to 42-fold against the four serogroups. Similar immune responses were observed for the age subgroups 2-10 years, 11-18 years, and 19-75 years. Seroresponse rates at 1 month following vaccination were 72%, 88%, 55%, and 71% for serogroups A, C, W, and Y, respectively. The vaccine was well tolerated with no safety concerns.
Conclusion: A single dose of MenACWY-CRM induced a robust immune response against all four meningococcal serogroups and was well tolerated in an Indian population 2-75 years of age.
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| http://dx.doi.org/10.1016/j.ijid.2015.07.003 | DOI Listing |
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