Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

852

Participants

Timeline

Start Date

May 22, 2020

Primary Completion Date

August 10, 2023

Study Completion Date

August 10, 2023

Conditions
Pneumococcal ImmunisationDiphtheria ImmunisationTetanus ImmunisationPertussis ImmunisationHepatitis B ImmunisationHaemophilus Influenzae Type b ImmunisationPolio ImmunisationMeasles ImmunisationRubella ImmunisationVaricella ImmunisationMumps Immunisation
Interventions
BIOLOGICAL

Pneumococcal Conjugate Vaccine formulation 1

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Pneumococcal Conjugate Vaccine formulation 2

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Pneumococcal Conjugate Vaccine formulation 3

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Varicella Virus Vaccine Live

Pharmaceutical form:liquid Route of administration: subcutaneous

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine Live

Pharmaceutical form:liquid Route of administration: subcutaneous

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Pharmaceutical form:liquid Route of administration: intramuscular

BIOLOGICAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Pharmaceutical form:liquid Route of administration: oral

BIOLOGICAL

Hepatitis B Vaccine* [Recombinant] *as applicable

Pharmaceutical form:liquid Route of administration: intramuscular

Trial Locations (57)

11101

Investigational Site Number : 3400002, Municipio Del Distrito Central

20016

Meridian Clinical Research Washington DC Site Number : 8400119, Washington D.C.

20815

Javara Chevy Chase Site Number : 8400138, Chevy Chase

21104

Investigational Site Number : 3400001, San Pedro Sula

21401

Javara Annapolis Site Number : 8400137, Annapolis

27103

Ardmore Medical Research Site Number : 8400043, Winston-Salem

28204

Atrium Health Site Number : 8400124, Charlotte

29520

Cheraw Pediatrics Site Number : 8400017, Cheraw

29607

Tribe Clinical Research Site Number : 8400025, Greenville

30080

Dumog Research Site Number : 8400134, Smyrna

30214

Javara Fayetteville Site Number : 8400139, Fayetteville

31707

Javara Albany Site Number : 8400140, Albany

31904

Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062, Columbus

33030

Homestead Medical Clinic, P.A. Site Number : 8400032, Homestead

33122

International Research Partners, LLC Site Number : 8400077, Doral

33135

Dade Research Center Site Number : 8400122, Miami

33155

Miami Clinical Research Site Number : 8400020, Miami

33164

Amber Clinical Research, LLC Site Number : 8400019, Miami

33617

Jedidiah Clinical Research Site Number : 8400049, Tampa

40517

Michael W. Simon, MD, PSC Site Number : 8400002, Lexington

42101

Qualmedica Research, LLC Site Number : 8400084, Bowling Green

45245

Pediatric Associates of Mt. Carmel Site Number : 8400005, Cincinnati

59804

Boeson Research Site Number : 8400004, Missoula

64108

Children's Mercy Hospital Site Number : 8400008, Kansas City

67502

Hutchinson Clinic Site Number : 8400074, Hutchinson

68131

Pediatric Infectious Diseases Research Site Number : 8400104, Omaha

68516

Lincoln Pediatric Group Site Number : 8400125, Lincoln

68803

Meridian Clinical Research Site Number : 8400102, Grand Island

70433

Benchmark Research Site Number : 8400012, Covington

70508

Velocity Clinical Research Lafayette Site Number : 8400132, Lafayette

70806

Meridian Clinical Research, LLC Site Number : 8400112, Baton Rouge

72401

The Children's Clinic Of Jonesboro PA Site Number : 8400143, Jonesboro

75230

Javara Dallas Site Number : 8400135, Dallas

75605

DCOL Center for Clinical Research Site Number : 8400107, Longview

76104

North Texas Clinical Trials Site Number : 8400015, Fort Worth

77090

Houston Clinical Research Associates Site Number : 8400023, Houston

78201

Benchmark Research San Antonio Site Number : 8400129, San Antonio

78205

Sun Research Institute Site Number : 8400011, San Antonio

78244

Tekton Research Site Number : 8400076, San Antonio

78503

Biopharma Informatic Site Number : 8400066, McAllen

79902

Pininos Pediatric Services Site Number : 8400121, El Paso

83221

Bingham Memorial Hospital Site Number : 8400067, Blackfoot

83404

Leavitt Clinical Research Site Number : 8400127, Idaho Falls

90057

Matrix Clinical Research Site Number : 8400059, Los Angeles

90255

Joint Clinical Trials Huntington Park Site Number : 8400030, Huntington Park

Matrix Clinical Research Huntington Park Site Number : 8400058, Huntington Park

90706

Southland Clinical Research Center Site Number : 8400040, Bellflower

91762

Orange County Research Institute Site Number : 8400060, Ontario

99202

MultiCare Institute for Research & Innovation Site Number : 8400024, Spokane

92123-1881

California Research Foundation Site Number : 8400052, San Diego

76550-1820

FMC Science, LLC Site Number : 8400086, Lampasas

V5Z4H4

Investigational Site Number : 1240002, Vancouver

B3K6R8

Investigational Site Number : 1240001, Halifax

L8M 1K7

Investigational Site Number : 1240006, Hamilton

00961

Investigational Site Number : 6300002, Bayamón

000784

Investigational Site Number : 6300004, Guayama

00935

Investigational Site Number : 6300001, San Juan

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT04398706 - Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants | Biotech Hunter | Biotech Hunter