Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles mumps rubella and varicella vaccine to children 12 to 18 months of age.

Wednesday, 23rd of January 2019 Print

Hum Vaccin Immunother. 2018 Nov 27. doi: 10.1080/21645515.2018.1549452. [Epub ahead of print]

Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles mumps rubella and varicella vaccine to children 12 to 18 months of age.

Haas H1 Richard P2 Eymin C3 Fiquet A3 Kuter B4 Soubeyrand B3.

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Abstract

This randomized trial conducted in France compared intramuscular (IM) and subcutaneous (SC) administration of two doses of a measles mumps rubella and varicella (MMRV) combination vaccine (ProQuad®) administered one month apart to 405 children 12-18 months of age (NCT00402831). The 2-dose regimen of MMRV administered IM was shown to be as immunogenic as the 2-dose regimen administered SC for all antigens 6 weeks post-vaccination for the subjects who were initially seronegative for measles mumps rubella or varicella (lower bounds of the two-sided 95% CIs for the difference in response rates for all antigens greater than -10% [range -2.1 for varicella to -3.0 for mumps]). The antibody response rates for all vaccine antigens 6 weeks after the second dose of MMRV were > 99% in both the IM and SC groups. Fewer subjects in the IM group experienced injection-site AEs compared with the SC group (17.8% and 28.6% post-dose 1 and 20.4% and 29.5% post-dose 2 respectively). From Day 0 to Day 4 post-dose 2 fewer subjects reported erythema and swelling in the IM group than in the SC group (15.4% and 27.0% and 6.0% and 12.5% respectively). In both groups most injection-site AEs started during the first four days after vaccination; their intensity was mainly mild or ≤2.5 cm. The rates of fever were comparable between the two groups after each dose of MMRV. In conclusion two doses of the MMRV vaccine were highly immunogenic and well tolerated when administered either SC or IM. ClinicalTrials.gov Identifier: NCT00402831.

 

KEYWORDS:

IM; Measles; ProQuad; SC; mumps; route of administration; rubella; varicella vaccine

 

PMID: 30481110 DOI: 10.1080/21645515.2018.1549452

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