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Safety and Immunogenicity of a Measles, Mumps, Rubella and Varicella Vaccine Given With Combined Haemophilus influenzae Type b Conjugate/Hepatitis B Vaccines and Combined Diphtheria-Tetanus-Acellular Pertussis Vaccines

Shinefield, Henry MD*; Black, Steve MD†; Thear, Marci MPH‡; Coury, Daniel MD§; Reisinger, Keith MD∥; Rothstein, Edward MD¶; Xu, Jin MS‡; Hartzel, Jonathan PhD‡; Evans, Barbara BS‡; Digilio, Laura MD‡; Schödel, Florian MD‡; Brown, Michelle L. Hoffman BS‡; Kuter, Barbara MPH, PhD‡; The 013 Study Group for ProQuad

Pediatric Infectious Disease Journal: April 2006 - Volume 25 - Issue 4 - pp 287-292
doi: 10.1097/01.inf.0000207857.10947.1f
Original Studies

Background: A study was conducted to assess administration of a combination measles, mumps, rubella and varicella vaccine (MMRV) with other childhood vaccines.

Methods: In this open, multicenter trial, 1915 healthy children ages 12–15 months were randomized into 3 groups: group 1, MMRV, combined Haemophilus influenzae type b conjugate-hepatitis B vaccines (Hib/HepB) and combined diphtheria-tetanus-acellular pertussis vaccines (DTaP) concomitantly; group 2, MMRV followed by Hib/HepB and DTaP 42 days later; group 3, MMR and varicella vaccine followed by Hib/HepB and DTaP 42 days later.

Results: Antibody responses to measles, mumps, rubella, varicella, Hib, HepB, diphtheria and tetanus were similar between groups 1 and 2 (all >95%, except varicella, 89.7% in group 1 and 90.9% in group 2). Pertussis toxin and filamentous hemagglutinin responses were significantly lower in group 1 than in group 2 (group 1, 74.1 and 67.1%; group 2, 90.4 and 86.8%, respectively). An exploratory analysis suggested that the difference in and pertussis toxin and filamentous hemagglutinin responses was likely the result of study design rather than interference among vaccine components because the groups differed in age of receipt of DTaP (group 1, ∼12 months; group 2, ∼13.5 months). When the groups were matched for age, sample size was sufficient for comparison only in children ≥13.5 months old. Pertussis toxin and filamentous hemagglutinin responses were similar in these children. The safety profiles for each vaccination regimen were comparable.

Conclusions: The immunogenicity data support concomitant administration of MMRV with Hib/HepB. Limited data from an exploratory analysis indicate that MMRV can be administered concomitantly with DTaP. Concomitant administration of MMRV, Hib/HepB and DTaP is well-tolerated.

From the *University of California School of Medicine, San Francisco, CA; †Kaiser Permanente, Oakland, CA; ‡Merck Research Laboratories, West Point, PA; §Children's Hospital of Columbus, OH; ∥Primary Physicians Research, Pittsburgh, PA; and ¶Pennridge Pediatric Associates, Sellersville, PA

Accepted for publication November 17, 2005.

Supported by a grant from Merck & Co., Inc.

Dr. Reisinger has participated in Merck Advisory Boards and participates in speaker programs for ProQuad that are sponsored by Merck & Co., Inc. Dr Shinefield is a member of the Merck Advisory Committee on Varicella and ProQuad and received an honorarium for preparation of an informational document on ProQuad for the medical profession.

Address for reprints: Steve Black, MD, Kaiser Permanente Vaccine Study Center, One Kaiser Plaza, 16th Floor, Oakland, CA 94612, E-mail STEVE.BLACK@KP.org.

© 2006 Lippincott Williams & Wilkins, Inc.