MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.

Overview

Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the reactogenicity and immunogenicity of the measles component of these vaccines. In addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered.

Full Title of Study: “Measles-mumps-rubella and Measles-mumps-rubella-varicella Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 2010

Interventions

  • Biological: MMR vaccine / MMRV vaccine
    • Subcutaneous injection, two doses

Arms, Groups and Cohorts

  • 12 months
    • MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age
  • 13 months
    • MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age
  • 14 months
    • MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age
  • 15 months or more
    • MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older

Clinical Trial Outcome Measures

Primary Measures

  • Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
    • Time Frame: At day 42 after administration of a dose of MMR or MMRV vaccine
    • Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL. The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL (performed on seronegative subjects prior to vaccination).

Secondary Measures

  • Injection site reaction
    • Time Frame: Days 0-3 after vaccination
    • Injection site reaction is defined by the presence of pain, redness and swelling
  • Systemic symptoms
    • Time Frame: Days 0 – 42 after administration of a dose of MMR or MMRV vaccine
    • Will include fever (defined as rectal temperature ≥38°C), general malaise and measles-like rash
  • Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV
    • Time Frame: 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines
    • Antibody titers are expressed as Geometric Mean Concentrations (GMC) in mIU/mL The cut-off for seropositivity is anti-measles antibody titer ≥ 150 mIU/mL

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male or female subject between 11 to 22 months at the time of first vaccination. – Written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria:

  • History of previous measles, mumps, rubella and/or varicella vaccination or disease or known exposure to any of these diseases within 30 days prior to the inclusion in the study. – Any confirmed or suspected immunosuppressive or immunodeficient condition, included the chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying drugs within six months prior to the firs vaccine dose. – History of any neurologic disorders or seizures. – History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines. – Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Gender Eligibility: All

Minimum Age: 11 Months

Maximum Age: 22 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • CHU de Quebec-Universite Laval
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gaston De Serres, MD, PhD – CHU de Quebec-Universite Laval
  • Overall Official(s)
    • Gaston De Serres, MD, PhD, Principal Investigator, CHU de Quebec-Universite Laval

References

Czajka H, Schuster V, Zepp F, Esposito S, Douha M, Willems P. A combined measles, mumps, rubella and varicella vaccine (Priorix-Tetra): immunogenicity and safety profile. Vaccine. 2009 Nov 5;27(47):6504-11. doi: 10.1016/j.vaccine.2009.07.076. Epub 2009 Aug 7. Erratum In: Vaccine. 2010 Dec 6;28(52):8352. Vaccine. 2012 Dec 14;30(52):7667.

Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22. Erratum In: Pediatr Infect Dis J. 2013 Apr;32(4):e163.

Knuf M, Habermehl P, Zepp F, Mannhardt W, Kuttnig M, Muttonen P, Prieler A, Maurer H, Bisanz H, Tornieporth N, Descamps D, Willems P. Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Pediatr Infect Dis J. 2006 Jan;25(1):12-8. doi: 10.1097/01.inf.0000195626.35239.58.

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