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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Biological:
MenACWY-CRM
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.
MenACWY-CRM
This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Routine Vaccines
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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
See also
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