Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years
| Autor: | Margaret Hoyle, Ashwani Kumar Arora, Shalaka Agarkhedkar, Paola Pedotti, Sanjay Lalwani, Urmila M Thatte, Sonali Palkar, Chiranjiwi Bhusal, Hoshang Vakil, Sharad Agarkhedkar, Nithya J Gogtay, Rekha Jonnalagedda |
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| Rok vydání: | 2015 |
| Předmět: |
Microbiology (medical)
Adult Male Pediatrics medicine.medical_specialty Adolescent India Meningococcal Vaccines Neisseria meningitidis Meningococcal disease Serogroup lcsh:Infectious and parasitic diseases Young Adult Conjugate vaccine medicine Humans lcsh:RC109-216 Adverse effect Child Aged Vaccines Conjugate business.industry Immunogenicity Indian population Quadrivalent vaccine General Medicine Middle Aged medicine.disease Antibodies Bacterial CRM197 conjugate Vaccination Meningococcal Infections Infectious Diseases Child Preschool Female Meningococcal conjugate vaccine Safety business |
| Zdroj: | International Journal of Infectious Diseases, Vol 38, Iss C, Pp 36-42 (2015) |
| ISSN: | 1878-3511 |
| Popis: | Summary 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. |
| Databáze: | OpenAIRE |
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