Clinical Trials Logo

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
  Status Clinical Trial Phase
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Completed NCT01434680 - Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers Phase 2
Completed NCT01452438 - Safety Surveillance of MenACWY-CRM Vaccine in Children N/A
Completed NCT01452464 - Safety of MenACWY-CRM Vaccination in Adolescents N/A
Completed NCT02173704 - Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan. Phase 3
Completed NCT01682876 - Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age. Phase 3
Recruiting NCT04023929 - Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT03378258 - Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
Recruiting NCT04239430 - Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study
Completed NCT01973218 - Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years. Phase 3
Completed NCT01994629 - Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers Phase 2
Completed NCT01725217 - Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia Phase 3
Completed NCT01717638 - Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 Phase 3
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT01000311 - A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months Phase 3
Completed NCT02141516 - Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects Phase 3
Completed NCT02140762 - Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents Phase 2
Completed NCT01823536 - Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose Phase 4
Completed NCT01478347 - A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults Phase 3