631. Tolerability of Co-Administration of Meningococcal Quadrivalent (MenACWY-CRM197) Conjugate Vaccine with Measles-Mumps-Rubella-Varicella (MMRV) Immunization in 12 Month-Old Toddlers
Session: Poster Abstract Session: Pediatric Vaccines
Friday, October 21, 2011
Room: Poster Hall B1
Background: A quadrivalent polysaccharide-protein conjugate vaccine (MenACWY-CRM197, Menveo®) is currently licensed in the USA for use from 2 years of age. To evaluate the impact of MenACWY-CRM on current routine vaccines, we studied the safety profile of two doses of MenACWY-CRM1administered at 7 to 9 and 12 months of age, the second dose being given either separately or concomitantly with the combination measles, mumps, rubella, varicella (MMRV, ProQuad®) vaccine.

Methods: In this phase 3, open-label, randomized, multi-center study 1630 healthy older infants and toddlers were enrolled and randomized to three groups: Group A (n = 504) received MenACWY at 7–9 months and MenACWY +MMRV at 12 months; Group B (n = 510) MenACWY at 7–9 and 12 months, and MMRV at 13.5 months; Group C (n = 616) MMRV only at 12 months. We assessed tolerability using parental diary cards which solicited local and systemic reactions for 7 days and any adverse events (AE) for 28 days after each vaccination. We monitored for any medically significant AE until the end of the study.  We also collected daily body temperatures for 28 days after MMRV vaccination.

Results: Premature withdrawals were spread across all groups and consistent with time-on-study (78, 88 and 59 from Groups A (11 months), B (11 months) and C (6 months), respectively); main reasons were due to withdrawal of consent (80), loss to follow-up (68), and protocol deviation/violation (56). Only one withdrawal was due to an AE. MMRV was associated with higher rates of solicited and other reactions, including the characteristic fever peak at Days 5-12.; these rates were not affected by concomitant MenACWY (Table). Severity of reactions was similar across groups. SAEs occurred at 4%, 4% and 2% in the three groups and none were considered to be vaccine-related.

 

Age (months)

7–9

12

13.5

 

Groups A & B

Group A

Group B

Group C

Group B

Vaccine(s)

MenACWY

MenACWY + MMRV

MenACWY

MMRV

MMRV

Reactions

N = 1000

N = 459

N = 456

N = 597

N = 429

Any

686 (69%)

337 (73%)

275 (60%)

478 (80%)

281 (66%)

Local

329 (33%)

227 (49%)

141 (31%)

316 (53%)

188 (44%)

Systemic

541 (54%)

263 (57%)

195 (43%)

381 (64%)

195 (45%)

Other

283 (28%)

143 (31%)

105 (23%)

203 (34%)

108 (25%)

 

Conclusion: Co-adminstration of Menveo with MMRV at 12 months of age did not affect the tolerability of either vaccine.


Subject Category: I. Adult and Pediatric Vaccines

Julie Shepard, MD, Ohio Pediatric Research Assn., Huber Heights,, OH, Nicola Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Kaiser Permanente, Oakland, CA, Tatjana Odrljin, MD, Novartis Vaccines & Diagnostics, Cambridge, MA, Lisa Bedell, MA, Novartis Vaccines and Diagnostics, Cambridge, MA and Peter Dull, MD, Clinical Development, Novartis Vaccines and Diagnostics, Cambridge, MA

Disclosures:

J. Shepard, None

N. Klein, None

T. Odrljin, Novartis Vaccines & Diagnostics: Employee, Salary

L. Bedell, Novartis Vaccines & Diagnostics: Employee, Salary

P. Dull, Novartis Vaccines & Diagnostics: Employee, Salary

See more of: Pediatric Vaccines
See more of: Poster Abstract Session

Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.