Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

Summary

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

Timeline

Start

2011-08

Primary completion

2011-10

Completion

2012-09

Outcome

Met primary endpoint

registry analysis (unspecified test); ABCWY+OMV vs ACWY; Group Difference % (ABCWY+OMV - ACWY) 16 (95% CI 5 to 29) NCT01272180 ↗

registry analysis (unspecified test); ABCWY+qOMV vs ACWY; Group Difference % (ABCWY+qOMV - ACWY) 18 (95% CI 7 to 30) NCT01272180 ↗

Publications

• Szenborn L, Block SL, Jackowska T, Konior R, D'Agostino D, Smolenov I, Toneatto D, Welsch JA. Immune Responses to Booster Vaccination With Meningococcal ABCWY Vaccine After Primary Vaccination With Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study. Pediatr Infect Dis J. 2018 May;37(5):475-482. doi: 10.1097/INF.0000000000001896.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	4CMenB	Vaccine	—	—
Subject	MenABCWY	Vaccine	—	—
Comparator	MenACWY-CRM	Vaccine	—	—
Subject	Outer Membrane Vesicles	Unknown	—	—

Indications