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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

Primary Purpose

Meningococcal Disease, Meningococcal Meningitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MenACWY-CRM
MenACWY-CRM
Routine Vaccines
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Infants, Persistence

Eligibility Criteria

55 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cotton ONeil Clinical Research
  • Cotton ONeil Clinical Research
  • Bluegrass Clinical Research (Bardstown Road)
  • Bluegrass Clinical Research (Brownsboro Park Blvd)
  • Children's Physicians Dundee
  • Creighton Univ
  • Rockwood Clinic P S
  • Rockwood Clinic P S

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MenACWY3

MenACWY4

Routine Vaccines

Arm Description

Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.

All the subjects 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.

Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.

Full Information

First Posted
September 27, 2010
Last Updated
September 10, 2018
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01214837
Brief Title
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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease, Meningococcal Meningitis
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Infants, Persistence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
751 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MenACWY3
Arm Type
Experimental
Arm Description
Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Arm Title
MenACWY4
Arm Type
Experimental
Arm Description
All the subjects 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.
Arm Title
Routine Vaccines
Arm Type
Placebo Comparator
Arm Description
Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM
Intervention Description
This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Intervention Type
Biological
Intervention Name(s)
Routine Vaccines
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
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.
Description
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.
Title
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.
Description
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.
Title
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.
Description
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
Title
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.
Description
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
Title
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.
Description
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
Title
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.
Description
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.
Title
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.
Description
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.
Title
Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.
Description
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
Title
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.
Description
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
Title
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Time Frame
13 months of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Fayetteville
State/Province
Arkansas
Country
United States
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Fountain Valley
State/Province
California
Country
United States
City
Huntington Beach
State/Province
California
Country
United States
City
Madera
State/Province
California
Country
United States
City
Nampa
State/Province
Idaho
Country
United States
Facility Name
Cotton ONeil Clinical Research
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Cotton ONeil Clinical Research
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
City
Bardstown
State/Province
Kentucky
Country
United States
Facility Name
Bluegrass Clinical Research (Bardstown Road)
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Bluegrass Clinical Research (Brownsboro Park Blvd)
City
Louisville
State/Province
Kentucky
Country
United States
City
Springfield
State/Province
Kentucky
Country
United States
City
Haughton
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Niles
State/Province
Michigan
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Children's Physicians Dundee
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Creighton Univ
City
Omaha
State/Province
Nebraska
Country
United States
City
Binghamton
State/Province
New York
Country
United States
City
Johnson City
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Huber Heights
State/Province
Ohio
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Lebanon
State/Province
Tennessee
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Tomball
State/Province
Texas
Country
United States
City
Layton
State/Province
Utah
Country
United States
City
Saint George
State/Province
Utah
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Rockwood Clinic P S
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Rockwood Clinic P S
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
City
Sudbury
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Pierrefonds
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26479973
Citation
Block SL, Shepard J, Garfield H, Xie F, Han L, Dull PM, Smolenov I. Immunogenicity and Safety of a 3- and 4-dose Vaccination Series of a Meningococcal ACWY Conjugate Vaccine in Infants: Results of a Phase 3b, Randomized, Open-label Trial. Pediatr Infect Dis J. 2016 Feb;35(2):e48-59. doi: 10.1097/INF.0000000000000965.
Results Reference
derived

Learn more about this trial

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

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