The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
751
This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.
Time frame: 13 months of age
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.
Time frame: 13 months of age
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.
Time frame: Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Time frame: Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Fayetteville, Arkansas, United States
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
Madera, California, United States
Unnamed facility
Nampa, Idaho, United States
Cotton ONeil Clinical Research
Topeka, Kansas, United States
Cotton ONeil Clinical Research
Topeka, Kansas, United States
...and 30 more locations
Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Time frame: 12 months of age.
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.
The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Time frame: 12 months of age
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.
Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.
Time frame: 13 months of age
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.
The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.
Time frame: 13 months of age
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.
Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.
Time frame: 7 months of age.
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.
Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.
Time frame: 13 months of age.
Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.
Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.
Time frame: Within 7 days
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.
Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.
Time frame: Day 1 through Day 7
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Time frame: 13 months of age