alexa Immunogenicity and Safety of Combined Tetanus, Reduced Diphtheria, Acellular Pertussis Vaccine when Co-Administered with Quadrivalent Meningococcal Conjugate and Human Papillomavirus Vaccines in Healthy Adolescents
ISSN: 2157-7560

Journal of Vaccines & Vaccination
Open Access

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Research Article

Immunogenicity and Safety of Combined Tetanus, Reduced Diphtheria, Acellular Pertussis Vaccine when Co-Administered with Quadrivalent Meningococcal Conjugate and Human Papillomavirus Vaccines in Healthy Adolescents

Roberto Gasparini1, William Johnston2, Michele Conversano3, Alan Garscadden4, David Alexanderian5, Noemi Giglioli5, Sandra Percell5, Linda Han5 and Igor Smolenov5*

1Department of Health Sciences, University of Genoa, Genoa, Italy

2Birmingham Pediatrics, Birmingham, AL, USA

3Taranto Local Health Unit, Department of Prevention, Taranto, Italy

4Clinical Research Advantage, Colorado Springs Health Partners, Colorado Springs, CO, USA

5Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA

*Corresponding Author:
Igor Smolenov
Novartis Vaccines
Hullenbergweg 83-85
P.O. Box 23023, NL-1100 DM
Amsterdam, Netherlands
Tel: +31205640551
Fax: +31205640565
E-mail: [email protected]

Received date: April 10 2014; Accepted date: May 21 2014; Published date: May 24 2014

Citation: Gasparini R, Johnston W, Conversano M, Garscadden A, Alexanderian D, et al. (2014) Immunogenicity and Safety of Combined Tetanus, Reduced Diphtheria, Acellular Pertussis Vaccine when Co-Administered with Quadrivalent Meningococcal Conjugate and Human Papillomavirus Vaccines in Healthy Adolescents. J Vaccines Vaccin 5:231 doi: 10.4172/2157-7560.1000231

Copyright: © 2014 Gasparini R, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Objective: Current United States immunization recommendations for adolescents include vaccines against tetanus, diphtheria and pertussis (Tdap), human papillomavirus (HPV), and Neisseria meningitidis serogroups A, C, W-135, and Y. In this Phase IV study, we primarily investigated the impact of concomitant administration of a quadrivalent meningococcal CRM197-conjugate vaccine (MenACWY-CRM) with Tdap and HPV vaccines, in terms of immunogenicity to Tdap antigens and overall reactogenicity. Methods: A total of 801 healthy adolescents aged 10-18 years were randomized to one of two groups to receive either MenACWY-CRM or a placebo, co-administered with Tdap and a quadrivalent HPV vaccine (HPV4). Antibody responses to the Tdap antigens, as well as to meningococcal serogroups A, C, W-135, and Y, were assessed at one month post-vaccination. Safety and adverse events were monitored throughout the study. Results: One month post-vaccination, 95% and 99% of subjects in the MenACWY-CRM group had seroprotective antibody levels (≥1.0 IU/mL) against the diphtheria and tetanus toxoids, respectively, compared with 82% and 98% in the placebo group. Ratios of geometric mean concentrations of antibodies against pertussis antigens pertussis toxin, filamentous hemagglutinin and pertactin for the MenACWY-CRM group versus placebo were 1.01, 0.84, and 0.82, respectively. Predetermined non-inferiority criteria for immunological responses against all Tdap antigens were met. Co-administration of a single dose of MenACWY-CRM was well tolerated and elicited robust antibody responses against the four meningococcal serogroups, with 77%, 84%, 95% and 86% of subjects having seroprotective human complement serum bactericidal activity (titers ≥8) against serogroups A, C, W-135, and Y, respectively, one month post-vaccination. Conclusions: Collectively, these results demonstrate that the MenACWY-CRM, Tdap and HPV4 vaccines can be administered at the same visit without compromising Tdap immune responses or increasing reactogenicity. [The study is registered with ClinicalTrials.gov, number NCT01424644].

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