Meningococcal Disease Clinical Trial
Official title:
A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life.
NCT number | NCT01214837 |
Other study ID # | V59_36 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | May 2012 |
Verified date | September 2018 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 751 |
Est. completion date | May 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Days to 89 Days |
Eligibility |
Inclusion Criteria: - Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits. Exclusion Criteria: - Serious, acute, or chronic illnesses are reasons for exclusion. |
Country | Name | City | State |
---|---|---|---|
United States | Bluegrass Clinical Research (Bardstown Road) | Louisville | Kentucky |
United States | Bluegrass Clinical Research (Brownsboro Park Blvd) | Louisville | Kentucky |
United States | Children's Physicians Dundee | Omaha | Nebraska |
United States | Creighton Univ | Omaha | Nebraska |
United States | Rockwood Clinic P S | Spokane | Washington |
United States | Rockwood Clinic P S | Spokane | Washington |
United States | Cotton ONeil Clinical Research | Topeka | Kansas |
United States | Cotton ONeil Clinical Research | Topeka | Kansas |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 13 months of age | |
Primary | 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. | 13 months of age | |
Secondary | 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. | Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age | |
Secondary | 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. | Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age. | |
Secondary | Percentage of Subjects With hSBA =1:8 Following 2 and 3 Infant Doses of MenACWY. | 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. | 12 months of age. | |
Secondary | 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. | 12 months of age | |
Secondary | 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. | 13 months of age | |
Secondary | 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. | 13 months of age | |
Secondary | 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. | 7 months of age. | |
Secondary | 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. | 13 months of age. | |
Secondary | 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. | Within 7 days | |
Secondary | 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. | Day 1 through Day 7 | |
Secondary | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | 13 months of age |
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