Status:
COMPLETED
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
Lead Sponsor:
Pfizer
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administe...
Detailed Description
The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.
Eligibility Criteria
Inclusion
- All subjects must satisfy ALL the following criteria at study entry:
- 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
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT01900899
Start Date
July 1 2013
End Date
November 1 2017
Last Update
June 17 2019
Active Locations (10)
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1
Espoo Vaccine Research Clinic
Espoo, Finland, 02230
2
Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
Helsinki, Finland, 00100
3
Helsinki East Vaccine Research Clinic
Helsinki, Finland, 00930
4
Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
Jarvenpaa, Finland, 60100