Clinical trial NCT01214837: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Infants
Persistence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 751
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 13 months of age
measure: 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.
timeFrame: 13 months of age
Secondary outcomes:
measure: 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.
timeFrame: Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age
measure: 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.
timeFrame: Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.
measure: Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.
timeFrame: 12 months of age.
measure: Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.
timeFrame: 12 months of age
measure: GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.
timeFrame: 13 months of age
measure: 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.
timeFrame: 13 months of age
measure: Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.
timeFrame: 7 months of age.
measure: Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.
timeFrame: 13 months of age.
measure: Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.
timeFrame: Within 7 days
measure: Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.
timeFrame: Day 1 through Day 7
measure: Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
timeFrame: 13 months of age
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Fayetteville
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Madera
country: United States
state: California
city: Nampa
country: United States
state: Idaho
city: Topeka
country: United States
facility: Cotton ONeil Clinical Research
state: Kansas
city: Topeka
country: United States
facility: Cotton ONeil Clinical Research
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research (Bardstown Road)
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research (Brownsboro Park Blvd)
state: Kentucky
city: Springfield
country: United States
state: Kentucky
city: Haughton
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Niles
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
facility: Children's Physicians Dundee
state: Nebraska
city: Omaha
country: United States
facility: Creighton Univ
state: Nebraska
city: Binghamton
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Huber Heights
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Kingsport
country: United States
state: Tennessee
city: Lebanon
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Saint George
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
facility: Rockwood Clinic P S
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic P S
state: Washington
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Pierrefonds
country: Canada
state: Quebec
Study officials:
References:
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.