Clinical trial NCT02712203: MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.
Official title: 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: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Measles
Keywords: Measles vaccine
Priorix
Priorix-Tetra
Age at vaccination
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2016-03-18
Enrollment: 5808
Sex: ALL
Minimum age (years): 11
Maximum age (years): 22
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 11 to 22 months selected to participate in clinical trials to assess the safety and immunogenicity of the GSK biological Priorix-Tetra™ in Germany, Austria, Finland, Greece, Poland, Czech Republic, Italy, Lithuania, Norway, Romania, Russian Federation, Slovakia, Sweden, United States and Puerto Rico.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV
timeFrame: At day 42 after administration of a dose of MMR or MMRV vaccine
Secondary outcomes:
measure: Injection site reaction
timeFrame: Days 0-3 after vaccination
measure: Systemic symptoms
timeFrame: Days 0 - 42 after administration of a dose of MMR or MMRV vaccine
measure: Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV
timeFrame: 2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Quebec-Universite Laval
name: Gaston De Serres, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.