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Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Sponsor: GlaxoSmithKline
Summary
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).
Key Details
Gender
All
Age Range
6 Weeks - 12 Weeks
Study Type
INTERVENTIONAL
Enrollment
1196
Start Date
2018-07-27
Completion Date
2024-12-27
Last Updated
2026-08-20
Healthy Volunteers
Yes
Conditions
Interventions
Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
Bexsero was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.
Prevnar13
Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.
Pediarix
Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121.
Hiberix
Hiberix (Hib) was administered intramuscularly on Day 1, Day 61, and Day 121.
Rotarix
Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61.
M-M-R II
M-M-R II (MMR) was administered intramuscularly on Day 301.
Varivax
Varivax (VV) was administered intramuscularly on Day 301.
Placebo (saline water)
Placebo was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.
Prevnar 20
Prevnar 20 (PCV13) was administered intramuscularly as a booster dose on Day 301 group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.
Locations (57)
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Lake Mary, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Fall River, Massachusetts, United States
GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Liverpool, New York, United States
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Syracuse, New York, United States
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Boone, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Fairfield, Ohio, United States
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South Euclid, Ohio, United States
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Hermitage, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
GSK Investigational Site
Clarksville, Tennessee, United States
GSK Investigational Site
Kingsport, Tennessee, United States
GSK Investigational Site
Beaumont, Texas, United States
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Bryan, Texas, United States
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Edinburg, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Layton, Utah, United States
GSK Investigational Site
Orem, Utah, United States
GSK Investigational Site
Provo, Utah, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Syracuse, Utah, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Spokane, Washington, United States
GSK Investigational Site
Marshfield, Wisconsin, United States
GSK Investigational Site
San Juan, Puerto Rico