Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
- Conditions
- Infections, Meningococcal
- Interventions
- Procedure: Blood Sampling
- Registration Number
- NCT01900899
- Lead Sponsor
- Pfizer
- 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 administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ACWY-TT group Blood Sampling Subjects primed and boosted with the MenACWY-TT vaccine. MenCCRM group Blood Sampling Subjects primed and boosted with the Meningitec vaccine.
- Primary Outcome Measures
Name Time Method Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination 48 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination 60 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination 24 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination 36 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination 72 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
- Secondary Outcome Measures
Name Time Method Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups 24, 36, 48, 60 and 72 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups 24, 36, 48, 60 and 72 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) Baseline up to the Month 72 after booster vaccination (up to 6 years) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups 24, 36, 48, 60 and 72 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups 24, 36, 48, 60 and 72 months after booster Vaccination Serogroups included MenA, MenC, MenW-135 and MenY.
Trial Locations
- Locations (10)
Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
🇫🇮Helsinki, Finland
Tampereen yliopisto/ Porin rokotetutkimusklinikka
🇫🇮Pori, Finland
Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
🇫🇮Vantaa, Finland
Helsinki East Vaccine Research Clinic
🇫🇮Helsinki, Finland
Espoo Vaccine Research Clinic
🇫🇮Espoo, Finland
Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
🇫🇮Jarvenpaa, Finland
Tampereen yliopisto/ Oulun rokotetutkimusklinikka
🇫🇮Oulu, Finland
Seinajoki Vaccine Research Clinic
🇫🇮Seinajoki, Finland
Tampere Vaccine Research Clinic
🇫🇮Tampere, Finland
Tampereen yliopisto/ Turun rokotetutkimusklinikka
🇫🇮Turku, Finland