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

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

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.

Study Overview

• Status: Unknown
• Conditions: Measles
• Intervention / Treatment: Biological: MMR vaccine / MMRV vaccine

• Study Type: Observational
• Enrollment (Actual): 5808

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
12 months; MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age	Biological: MMR vaccine / MMRV vaccine; Subcutaneous injection, two doses; Other Names: Priorix®; Priorix-Tetra®
13 months; MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age	Biological: MMR vaccine / MMRV vaccine; Subcutaneous injection, two doses; Other Names: Priorix®; Priorix-Tetra®
14 months; MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age	Biological: MMR vaccine / MMRV vaccine; Subcutaneous injection, two doses; Other Names: Priorix®; Priorix-Tetra®
15 months or more; MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age or older	Biological: MMR vaccine / MMRV vaccine; Subcutaneous injection, two doses; Other Names: Priorix®; Priorix-Tetra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection site reaction	Injection site reaction is defined by the presence of pain, redness and swelling	Days 0-3 after vaccination
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
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

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Gaston De Serres, MD, PhD, CHU de Quebec-Universite Laval

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): July 1, 2010
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Estimate): March 18, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Measles vaccine; Priorix; Priorix-Tetra; Age at vaccination
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Measles; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 200783