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

NCT02712203 | Unknown

• 1 other identifier: 200783
• Study Type: observational
• Target: 5,808
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Measles

Keywords

Measles vaccine; Priorix; Priorix-Tetra; Age at vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Injection site reaction

  Days 0-3 after vaccination

• Systemic symptoms

  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

  2 and 3 years after vaccination with 2 doses of MMR or MMRV vaccines

Study Arms (4)

12 months

MMR vaccine / MMRV vaccine : administration of the first dose at 12 months of age

Biological: MMR vaccine / MMRV vaccine

13 months

MMR vaccine / MMRV vaccine : administration of the first dose at 13 months of age

Biological: MMR vaccine / MMRV vaccine

14 months

MMR vaccine / MMRV vaccine : administration of the first dose at 14 months of age

Biological: MMR vaccine / MMRV vaccine

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

Interventions

MMR vaccine / MMRV vaccine BIOLOGICAL

Subcutaneous injection, two doses

Also known as: Priorix®, Priorix-Tetra®

12 months; 13 months; 14 months; 15 months or more

Eligibility Criteria

• Age: 11 Months - 22 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• GlaxoSmithKline: collaborator

Related 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.

  PMID: 19665608 BACKGROUND

• 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.

  PMID: 18600190 BACKGROUND

• 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.

  PMID: 16395096 BACKGROUND

MeSH Terms

Conditions

Measles

Interventions

Measles-Mumps-Rubella Vaccine; measles, mumps, rubella, varicella vaccine; Priorix-Tetra vaccine

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• Gaston De Serres, MD, PhD

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 18, 2016
• Study Start: July 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2016
• Last Updated: March 18, 2016

Record last verified: 2016-03