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COMPLETED
NCT03621670
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)

Bexsero was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.

BIOLOGICAL

Prevnar13

Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.

BIOLOGICAL

Pediarix

Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121.

BIOLOGICAL

Hiberix

Hiberix (Hib) was administered intramuscularly on Day 1, Day 61, and Day 121.

BIOLOGICAL

Rotarix

Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61.

BIOLOGICAL

M-M-R II

M-M-R II (MMR) was administered intramuscularly on Day 301.

BIOLOGICAL

Varivax

Varivax (VV) was administered intramuscularly on Day 301.

BIOLOGICAL

Placebo (saline water)

Placebo was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301.

BIOLOGICAL

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

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Liverpool, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Boone, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Fairfield, Ohio, United States

GSK Investigational Site

South Euclid, Ohio, United States

GSK Investigational Site

Hermitage, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

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

GSK Investigational Site

Bryan, Texas, United States

GSK Investigational Site

Edinburg, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

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