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

Measles Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02712203
• Other study ID #: 200783
• Status: Active, not recruiting
• Phase: N/A
• First received: March 14, 2016
• Last updated: March 14, 2016
• Start date: July 2004
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5808
• Est. completion date: December 2016
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Months to 22 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Measles

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	GlaxoSmithKline

References & Publications (3)

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. Review. Erratum in: Vaccine. 2012 Dec 14;30(52):7667. Vaccine. 2010 Dec 6;28(52):8352. — View 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. — View 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. Erratum in: Pediatr Infect Dis J. 2013 Apr;32(4):e163. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term seropositivity rates & anti-measles antibody titers after vaccination with MMR or MMRV	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).	At day 42 after administration of a dose of MMR or MMRV vaccine	No
Secondary	Injection site reaction	Injection site reaction is defined by the presence of pain, redness and swelling	Days 0-3 after vaccination	Yes
Secondary	Systemic symptoms	Will include fever (defined as rectal temperature =38°C), general malaise and measles-like rash	Days 0 - 42 after administration of a dose of MMR or MMRV vaccine	Yes
Secondary	Long term seropositivity rates and anti-measles antibody titers after vaccination with MMR or MMRV	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	2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines	No