628. Immunogenicity of GlaxoSmithKline Biologicals, MMR Vaccine vs M-M-R® II, when Co-administered with Hepatitis A, Varicella and Pneumococcal Conjugate Vaccines to Toddlers Aged 12–15 Months
Session: Poster Abstract Session: Pediatric Vaccines
Friday, October 21, 2011
Room: Poster Hall B1
Background: This study assessed the immunogenicity of a candidate measles, mumps, rubella (MMR) vaccine (Priorix™) and the US standard of care vaccine when used as a first dose among eligible US toddlers.

Methods: For this Phase 2, multicenter, observer-blind study, 1220 toddlers aged 12–15 months were randomized 3:3:3:3 to receive 1 dose of 1 of 3 lots of MMR (GSK) with different mumps virus potencies (MMR-1, MMR-2, MMR-3) or M-M-R®II (Merck), co-administered with hepatitis A (HAV), varicella (VZV) and pneumococcal conjugate (PCV) vaccines. The immune response against measles, mumps, and rubella viruses was assessed 42 days after vaccination. Incidence of solicited local (Day 0–3) and general (Day 0–42) adverse events (AEs) and serious AEs (Day 0–180) were reported.

Results: 

The table summarizes immunogenicity data (seroresponse rates [SR] and geometric mean antibody concentrations/titers [GMC/Ts] with 95% confidence intervals [CI]) for measles, mumps, and rubella. SRs and GMC/Ts for the 3 viruses were similar between the 2 vaccines and for the 3 lots of MMR vaccine containing different mumps potencies.

Vaccine

(mumps titer)

SR

[95% CI]

GMCs

[95% CI]

GMTs

[95% CI]

Measles

≥200 mIU/mL

Rubella

≥10 IU/mL

Mumps

≥51 ED50

Measles

Rubella

Mumps

MMR-1

(3.7 Log10 CCID50)

98.3

[95.8–99.5]

97.5

[94.6–99.1]

89.7

[84.6–93.6]

2593

[2350–2861]

68.2

[61.8–75.3]

253

[213.4–300.9]

MMR-2

(4.1 Log10 CCID50)

98.3

[95.8–99.5]

98.7

[96.4–99.7]

90.6

[85.7–94.2]

2878

[2607–3178]

77.7

[70.4–85.7]

265

[221.8–316.5]

MMR-3

(4.8 Log10 CCID50)

99.2

[97.1–99.9]

98.8

[96.5–99.7]

90.7

[85.7–94.4]

2799

[2545–3078]

72.2

[65.6–79.6]

242

[204.5–286.5]

M-M-R II

99.6

[97.8–100]

100

[98.5–100]

91.1

[86.2–94.8]

2949

[2698–3224]

89.4

[81.4–98.2]

268

[224.2–319.5]

Similar immune responses to co-administrated vaccines (HAV, VZV, and PCV-7) were elicited when given with either MMR (1, 2 or 3) or M-M-R II. Incidence of solicited and unsolicited AEs and SAEs were similar among the 4 groups.

Conclusion: Overall, the data demonstrate a similar immune response to the 3 lots of MMR, compared with M-M-R II. There was no obvious dose-response relationship noted over the broad range of mumps potencies in the MMR vaccine.


Subject Category: I. Adult and Pediatric Vaccines

Maurice Mufson1, Clemente Diaz2, Michael Leonardi3, Christopher Harrison4, Stanley Grogg5, Antonio Carbayo6, Simon Carlo-Torres7, Robert Jeanfreau, MD8, Ana Quintero-Del-Rio9, Gisele Bautista10, Ouzama Nicholson11, Bruce Innis11, Michael Povey12 and Christopher Da Costa11, (1)Marshall University, Joan C Edwards School of Medicine, Huntington, WV, (2)University of Puerto Rico School of Medicine, San Juan , PR, (3)Palmetto Pediatrics PA, Charleston, SC, (4)Children’s Mercy Hospital and Clinics, and University of Missouri at Kansas City, Kansas City, MO, (5)Oklahoma State University, Center for Health Sciences, Tulsa, OK, (6)Antonio Carbayo MD INC DBA, Full Health University Medical Clinic, Santa Ana, CA, (7)Molecular Medicine Dept., Hospital de La Concepcion, San German, PR, (8)Benchmark Research, Metairie, LA, (9)Pediatric Rheumatology Center of Puerto Rico, Bayamon Medical Plaza, Suite 910, Bayamon, PR, (10)Premier Health Research Center, Downey, CA, (11)GlaxoSmithKline Biologicals, King of Prussia, PA, (12)GlaxoSmithKline Biologicals, Wavre, Belgium

Disclosures:

M. Mufson, MedImmune: Grant Investigator, Research grant

C. Diaz, None

M. Leonardi, GSK: Investigator, Research grant

C. Harrison, GlaxoSmithKline: Investigator, Research grant

S. Grogg, GSK: Investigator, Research grant

A. Carbayo, None

S. Carlo-Torres, None

R. Jeanfreau, None

A. Quintero-Del-Rio, None

G. Bautista, None

O. Nicholson, GSK Biologicals: Employee, Salary

B. Innis, GSK: Employee and Shareholder, Salary and Stock

M. Povey, GSK: Employee, Salary

C. Da Costa, None

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.