Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
NCT ID: NCT01506193
Last Updated: 2018-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
716 participants
INTERVENTIONAL
2012-02-06
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
PriorixTetra™
One dose administered subcutaneously
Meningitec
One dose administered intramuscularly
Group B
Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
PriorixTetra™
One dose administered subcutaneously
Meningitec
One dose administered intramuscularly
Group C
Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
PriorixTetra™
One dose administered subcutaneously
Meningitec
One dose administered intramuscularly
Interventions
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PriorixTetra™
One dose administered subcutaneously
Meningitec
One dose administered intramuscularly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/ LAR of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
* History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
* Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* Acute disease and/or fever at the time of enrollment.
* Documented human immunodeficiency virus (HIV) positive subject.
* Any contraindications as stated in the Summary of Product Characteristics.
* Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
13 Months
15 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Chiavari, Liguria, Italy
GSK Investigational Site
Genoa, Liguria, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Cuneo, Piedmont, Italy
GSK Investigational Site
Novara, Piedmont, Italy
GSK Investigational Site
Alghero (SS), Sardinia, Italy
GSK Investigational Site
Cagliari, Sardinia, Italy
GSK Investigational Site
Sassari, Sardinia, Italy
GSK Investigational Site
Catania, Sicily, Italy
GSK Investigational Site
Modica (RG), Sicily, Italy
GSK Investigational Site
Ragusa (RG), Sicily, Italy
Countries
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References
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Durando P, Esposito S, Bona G, Cuccia M, Desole MG, Ferrera G, Gabutti G, Pellegrino A, Salvini F, Henry O, Povey M, Marchetti F. The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy. Vaccine. 2016 Aug 5;34(36):4278-84. doi: 10.1016/j.vaccine.2016.07.009. Epub 2016 Jul 14.
Other Identifiers
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2011-001608-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
115555
Identifier Type: -
Identifier Source: org_study_id
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