Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
NCT ID: NCT01900899
Last Updated: 2019-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
184 participants
INTERVENTIONAL
2013-07-31
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ACWY-TT group
Subjects primed and boosted with the MenACWY-TT vaccine.
Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
MenCCRM group
Subjects primed and boosted with the Meningitec vaccine.
Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
Interventions
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Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
Eligibility Criteria
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Inclusion Criteria
* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
* Child in care.
* History of meningococcal disease.
* Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Espoo Vaccine Research Clinic
Espoo, , Finland
Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
Helsinki, , Finland
Helsinki East Vaccine Research Clinic
Helsinki, , Finland
Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
Järvenpää, , Finland
Tampereen yliopisto/ Oulun rokotetutkimusklinikka
Oulu, , Finland
Tampereen yliopisto/ Porin rokotetutkimusklinikka
Pori, , Finland
Seinajoki Vaccine Research Clinic
Seinäjoki, , Finland
Tampere Vaccine Research Clinic
Tampere, , Finland
Tampereen yliopisto/ Turun rokotetutkimusklinikka
Turku, , Finland
Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
Vantaa, , Finland
Countries
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References
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Vesikari T, Forsten A, Laudat F, Li P, Van Der Wielen M, Hezareh M, Perez JL, Webber C. Long-term antibody persistence after a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in healthy 5-year-old children. Vaccine. 2020 May 8;38(22):3902-3908. doi: 10.1016/j.vaccine.2020.02.030. Epub 2020 Apr 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C0921001
Identifier Type: OTHER
Identifier Source: secondary_id
2012-005816-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
200088
Identifier Type: OTHER
Identifier Source: secondary_id
MENACWY-TT-102
Identifier Type: -
Identifier Source: org_study_id
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