NCT03621670 - Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants | Biotech Hunter

Enrollment

1,196

Participants

Timeline

Start Date

July 27, 2018

Primary Completion Date

December 27, 2024

Study Completion Date

December 27, 2024

Conditions

Infections, Meningococcal

Interventions

BIOLOGICAL

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

Bexsero is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group.

BIOLOGICAL

Prevnar13

Prevnar13 (PCV13) is to be administered intramuscularly on upper side of the left thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

BIOLOGICAL

Pediarix

Pediarix (DTPa-HBV-IPV) is to be administered intramuscularly on lower side of the left thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.

BIOLOGICAL

Hiberix

Hiberix (Hib) is to be administered intramuscularly on lower side of the right thigh as a 3-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) and Visit 3 (Day 121) to all subjects in the MenB+PCV group and Placebo+PCV group.

BIOLOGICAL

Rotarix

Rotarix (HRV) is to be administered orally as a 2-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61) to all subjects in the MenB+PCV group and Placebo+PCV group.

BIOLOGICAL

M-M-R II

M-M-R II (MMR) is to be administered subcutaneously on upper side of the right arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

BIOLOGICAL

Varivax

Varivax (VV) is to be administered subcutaneously on upper side of the left arm as a single dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group.

BIOLOGICAL

Placebo (saline water)

Placebo is to be administered intramuscularly on upper side of the right thigh as a 4-dose schedule on Visit 1 (Day 1), Visit 2 (Day 61), Visit 3 (Day 121) and Visit 5 (Day 301) to all subjects in the Placebo+PCV group.

BIOLOGICAL

Prevnar 20

Prevnar 20 (PCV13) is to be administered intramuscularly as a booster dose on Visit 5 (Day 301) to all subjects in the MenB+PCV group and Placebo+PCV group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose.

Trial Locations (59)

13090

GSK Investigational Site, Liverpool

13210

GSK Investigational Site, Syracuse

15224

GSK Investigational Site, Pittsburgh

16148

GSK Investigational Site, Hermitage

21201

GSK Investigational Site, Baltimore

23298

GSK Investigational Site, Richmond

27609

GSK Investigational Site, Raleigh

28607

GSK Investigational Site, Boone

29406

GSK Investigational Site, Charleston

29414

GSK Investigational Site, Charleston

32746

GSK Investigational Site, Lake Mary

33142

GSK Investigational Site, Miami

33613

GSK Investigational Site, Tampa

35205

GSK Investigational Site, Birmingham

37040

GSK Investigational Site, Clarksville

37660

GSK Investigational Site, Kingsport

40004

GSK Investigational Site, Bardstown

40202

GSK Investigational Site, Louisville

40207

GSK Investigational Site, Louisville

40291

GSK Investigational Site, Louisville

44121

GSK Investigational Site, South Euclid

45014

GSK Investigational Site, Fairfield

45245

GSK Investigational Site, Cincinnati

45406

GSK Investigational Site, Dayton

45414

GSK Investigational Site, Dayton

48025

GSK Investigational Site, Bingham Farms

54449

GSK Investigational Site, Marshfield

57105

GSK Investigational Site, Sioux Falls

64108

GSK Investigational Site, Kansas City

66604

GSK Investigational Site, Topeka

67114

GSK Investigational Site, Newton

68128

GSK Investigational Site, Omaha

68516

GSK Investigational Site, Lincoln

72401

GSK Investigational Site, Jonesboro

72703

GSK Investigational Site, Fayetteville

77065

GSK Investigational Site, Houston

77090

GSK Investigational Site, Houston

77706

GSK Investigational Site, Beaumont

77802

GSK Investigational Site, Bryan

78229

GSK Investigational Site, San Antonio

78244

GSK Investigational Site, San Antonio

83686

GSK Investigational Site, Nampa

83702

GSK Investigational Site, Nampa

84041

GSK Investigational Site, Layton

84057

GSK Investigational Site, Orem

84067

GSK Investigational Site, Roy

84075

GSK Investigational Site, Syracuse

84121

GSK Investigational Site, Salt Lake City

84604

GSK Investigational Site, Provo

91790

GSK Investigational Site, West Covina

92804

GSK Investigational Site, Anaheim

94015

GSK Investigational Site, Daly City

94596

GSK Investigational Site, Walnut Creek

94611

GSK Investigational Site, Oakland

95661

GSK Investigational Site, Roseville

99202

GSK Investigational Site, Tacoma

02721

GSK Investigational Site, Fall River

00907

GSK Investigational Site, San Juan

Unknown

GSK Investigational Site, Edinburgh