Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CRM vaccine to the licensed vaccine: results from a randomized, controlled, observer-blind study in adolescents and young adults

Author:

Díez-Domingo Javier1ORCID,Tinoco Juan Carlos2,Poder Airi3,Dinleyici Ener Cagri4,Nell Haylene5,Salamanca de la Cueva Ignacio6ORCID,Ince Tolga7,Moreira Edson Duarte8ORCID,Ahmed Khatija9,Luz Kleber10,Kovshirina Yulia11,Medina Pech Carlos Eduardo12,Akhund Tauseefullah13,Romolini Valerio14,Costantini Marco14ORCID,Mzolo Thembile15,Kunnel Barry16,Lechevin Isabelle17,Aggravi Marianna18,Tiberi Paola19,Narendran K20,García-Martínez Juan-Antonio21ORCID,Basile Venere22ORCID,Fragapane Elena13,Lattanzi Maria13ORCID,Pellegrini Michele13ORCID

Affiliation:

1. Vaccine Research Area, FISABIO-Public Health, Valencia, Spain

2. Infectious Disease, Hospital General de Durango, Durango, Mexico

3. Kliiniliste Uuringute Keskus, Tartu, Estonia

4. Pediatrics, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey

5. Tiervlei Trial Centre, Karl Bremer Hospital, Bellville, South Africa

6. Instituto Hispalense de Pediatria, Seville, Spain

7. Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey

8. Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil

9. Setshaba Research Centre, Tshwane, and Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa

10. Centro de Pesquisas Clinicas de Natal, Rio Grande do Norta, Brazil

11. Infectious Diseases and Epidemiology, Siberian State Medical University, Tomsk, Russian Federation

12. Medical Care and Research SA de CV, Mérida, Mexico

13. Clinical Research and Development Centre, GSK, Siena, Italy

14. Biostatistics, GSK, Siena, Italy

15. Biostatistics, GSK, Amsterdam, The Netherlands

16. Data Strategy & Management, Global Clinical Operations Development – R&D, GSK, Amsterdam, The Netherlands

17. Clinical Laboratory Sciences, GSK, Rixensart, Belgium

18. Technical Development, GSK, Siena, Italy

19. Safety Evaluation and Risk Management, GSK, Siena, Italy

20. Global Clinical Operations, GSK, Bangalore, India

21. Medical Department, GSK, Madrid, Spain

22. Global Clinical Delivery, Global Clinical Operations Development, GSK, Siena, Italy

Funder

GlaxoSmithKline Biologicals SA

Publisher

Informa UK Limited

Subject

Pharmacology,Immunology,Immunology and Allergy

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