This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,648
At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.
At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.
At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
Radiant Research, Inc.
Birmingham, Alabama, United States
Costal Clinical Research, Inc.
Daphne, Alabama, United States
Clinical Research Advantage Inc/ East Valley Family Physicians, PLC
Chandler, Arizona, United States
Radiant Research, Inc.
Chandler, Arizona, United States
Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
Mesa, Arizona, United States
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens
Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
Time frame: 1 Month after Vaccination 1
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens
Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.
Time frame: 1 Month after Vaccination 1
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens
Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.
Time frame: 1 Month after Vaccination 1
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3
Antibody hSBA GMTs of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Time frame: 1 Month after Vaccination 3
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens
Seroconversion rate for Tdap antigens was defined as greater than or equal to (\>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (\<=), greater than (\>) cutoff value, respectively. For MCV4 antigens \>=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value \>= lower limit of quantitation (LLOQ), postdose rSBA titers \>=2×LLOQ if baseline value was less than (\<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.
Time frame: 1 Month after Vaccination 1
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens
Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.
Time frame: 1 Month after Vaccination 1
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2
Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.
Time frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)
Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 \[A22\] and 1:8 for PMB2948 \[B24\].
Time frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] with hSBA titers \>=1:4, \>=1:8, \>=1:16, \>=1:32, \>=1:64, and \>=1:128 were computed along with corresponding 2-sided 95% CIs.
Time frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3
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Clinical Research Advantage, Inc./Desert
Mesa, Arizona, United States
Radiant Research, Inc.
Tucson, Arizona, United States
Radiant Research, Inc.
Tucson, Arizona, United States
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
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