IMMUNOGENICITY AND SAFETY OF MMRV AND PCV-7 ADMINISTERED CONCOMITANTLY IN HEALTHY CHILDREN

Monday, 1st of September 2014

[source]Pediatrics[|source]

In February 2000, a pneumococcal 7-valent conjugate vaccine (PCV-7) (Prevnar [Pfizer, Philadelphia, PA]) was licensed in the United States for use in infants and young children. The Advisory Committee on Immunization Practices (ACIP) recommends that the vaccine be administered in a 4-dose series for all children 2 to 23 months of age and for children 24 to 59 months of age who are at increased risk for pneumococcal disease. In turn, concomitant administration of MMRV and PCV-7 in the US could occur at 12 months and 4 to 6 years of age.

In this report, the authors conducted a randomized multicenter trial to assess whether concomitant administration of MMRV and PCV-7 in children 12 to 15 months of age would affect the safety or the antibody response to any of the components of either vaccines.  The report documents that concomitant administration of MMRV and PCV-7 is highly immunogenic and generally well tolerated. More details and recommendations are accessible at: http://pediatrics.aappublications.org/content/128/6/e1387.long

ABSTRACT

OBJECTIVE: We assessed the immunogenicity and safety of a combination measles, mumps, rubella, and varicella vaccine (MMRV) (ProQuad [Merck & Co, Inc, West Point, PA]) administered to healthy children concomitantly with a pneumococcal 7-valent conjugate vaccine (PCV-7) (Prevnar [Pfizer, Philadelphia, PA]).

PATIENTS AND METHODS: Healthy 12- to 15-month-old children who lacked vaccination and clinical histories for measles, mumps, rubella, varicella, and zoster but had written documentation of receipt of a 3-dose primary series of PCV-7 were randomly assigned in a 2:1:1 ratio to receive either the MMRV and PCV-7 (group 1), PCV-7 followed 6 weeks later by MMRV (group 2), or MMRV followed 6 weeks later by PCV-7 (group 3). The primary safety analysis was 56 days (28 days after each visit). Immunogenicity was evaluated 6 weeks after each vaccination.

RESULTS: A total of 1027 children were enrolled (group 1: 510; group 2: 258; group 3: 259). For all 3 groups, the antibody response rate was ≥96.8% for measles, mumps, and rubella, ≥88.0% for varicella-zoster virus, and ≥98.3% for all of the 7 Streptococcus pneumoniae serotypes. The immune responses to all antigens present in MMRV and PCV-7 were similar whether administered concomitantly or sequentially. The incidence of local and systemic adverse experiences (AEs) was comparable between group 1 and groups 2 and 3 combined. No vaccine-related serious AEs were reported.

CONCLUSIONS: Concomitant administration of the MMRV and PCV-7 is highly immunogenic and generally well tolerated. Similar immune responses between the groups support concomitant administration of the MMRV and PCV-7 to healthy children 12 to 15 months of age.