A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Timeline

Start

2007-03

Primary completion

2008-09

Completion

2009-11

Outcome

Met primary endpoint

paper Geometric mean titers were higher after the fourth dose of MenACWY-CRM compared with a single dose of MenACWY-CRM at 12 months of age PMID 22094635 ↗

registry US1A (MenACWY- CRM + Infant Vaccines ) vs US2 (Infant Vaccine Only); Ratio of GMTs 4.53 (95% CI 3.04 to 6.74) NCT00474526 ↗

registry US1A (MenACWY- CRM + Infant Vaccines ) vs US2 (Infant Vaccine Only); Ratio of GMTs 6.39 (95% CI 4.16 to 9.79) NCT00474526 ↗

registry US1A (MenACWY- CRM + Infant Vaccines ) vs US2 (Infant Vaccine Only); Ratio of GMTs 37 (95% CI 24 to 58) NCT00474526 ↗

registry US1A (MenACWY- CRM + Infant Vaccines ) vs US2 (Infant Vaccine Only); Ratio of GMTs 38 (95% CI 24 to 60) NCT00474526 ↗

Publications

• Results Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, Dull P. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012 Jan;31(1):64-71. doi: 10.1097/INF.0b013e31823dce5c.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ActHIB® (Haemophilus influenzae type b Conjugate Vaccine)	Vaccine	—	—
Subject	DTaP-IPV-HBV	Vaccine	—	—
Subject	Havrix® (Hepatitis A Vaccine, Inactivated)	Vaccine	—	—
Subject	Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)	Vaccine	—	—
Subject	Meningococcal ACWY Conjugate Vaccine	Vaccine	—	—
Subject	Pneumococcal 7-valent Conjugate Vaccine	Vaccine	—	—
Subject	ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)	Vaccine	—	—
Subject	Rotavirus	Vaccine	—	Oral

Indications