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
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.
1 other identifier
interventional
751
2 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
October 2, 2014
CompletedOctober 9, 2018
September 1, 2018
1.5 years
September 27, 2010
August 20, 2014
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (11)
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
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.
Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.
12 months of age.
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.
12 months of age
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.
13 months of age
- +6 more secondary outcomes
Study Arms (3)
MenACWY3
EXPERIMENTALSubjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
MenACWY4
EXPERIMENTALAll 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.
Routine Vaccines
PLACEBO COMPARATORSubjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Fayetteville, Arkansas, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Madera, California, United States
Unknown Facility
Nampa, Idaho, United States
Cotton ONeil Clinical Research
Topeka, Kansas, 66604, United States
Cotton ONeil Clinical Research
Topeka, Kansas, 66614, United States
Unknown Facility
Bardstown, Kentucky, United States
Bluegrass Clinical Research (Bardstown Road)
Louisville, Kentucky, United States
Bluegrass Clinical Research (Brownsboro Park Blvd)
Louisville, Kentucky, United States
Unknown Facility
Springfield, Kentucky, United States
Unknown Facility
Haughton, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Niles, Michigan, United States
Unknown Facility
Lincoln, Nebraska, United States
Children's Physicians Dundee
Omaha, Nebraska, United States
Creighton Univ
Omaha, Nebraska, United States
Unknown Facility
Binghamton, New York, United States
Unknown Facility
Johnson City, New York, United States
Unknown Facility
Syracuse, New York, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Huber Heights, Ohio, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Kingsport, Tennessee, United States
Unknown Facility
Lebanon, Tennessee, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Tomball, Texas, United States
Unknown Facility
Layton, Utah, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
St. George, Utah, United States
Unknown Facility
Richmond, Virginia, United States
Rockwood Clinic P S
Spokane, Washington, 99202, United States
Rockwood Clinic P S
Spokane, Washington, 99218, United States
Unknown Facility
Greater Sudbury, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Pierrefonds, Quebec, Canada
Related Publications (1)
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.
PMID: 26479973DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2010
First Posted
October 5, 2010
Study Start
October 1, 2010
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
October 9, 2018
Results First Posted
October 2, 2014
Record last verified: 2018-09