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Trial record 2 of 56 for:    priorix | Measles

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

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ClinicalTrials.gov Identifier: NCT02712203
Recruitment Status : Unknown
Verified March 2016 by Gaston De Serres, CHU de Quebec-Universite Laval.
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : March 18, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Gaston De Serres, CHU de Quebec-Universite Laval

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.


Condition or disease Intervention/treatment
Measles Biological: MMR vaccine / MMRV vaccine

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Study Type : Observational
Actual Enrollment : 5808 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : July 2004
Actual Primary Completion Date : July 2010
Estimated Study Completion Date : December 2016


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®




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Injection site reaction [ Time Frame: Days 0-3 after vaccination ]
    Injection site reaction is defined by the presence of pain, redness and swelling

  2. 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

  3. 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



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Ages Eligible for Study:   11 Months to 22 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712203


Sponsors and Collaborators
CHU de Quebec-Universite Laval
GlaxoSmithKline
Investigators
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Principal Investigator: Gaston De Serres, MD, PhD CHU de Quebec-Universite Laval
Publications:
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Responsible Party: Gaston De Serres, MD, PhD, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02712203    
Other Study ID Numbers: 200783
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016
Keywords provided by Gaston De Serres, CHU de Quebec-Universite Laval:
Measles vaccine
Priorix
Priorix-Tetra
Age at vaccination
Additional relevant MeSH terms:
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Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs