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

Who is this study for? Vaccines in Healthy Toddlers and Infants
Status: Completed
Location: See all (57) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Primary objectives: * To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection). * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8) Secondary objectives: * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8) * In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel * In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX\])

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: t
View:

⁃ Toddlers and infants:

• Participant and parent/guardian are able to attend all scheduled visits and to comply with all study procedures

• Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 5.5 lbs or 2.5 kg

⁃ Specifically for toddlers:

• Aged 12 to 15 months on the day of the first study visit

• Participant has received 3 doses of Prevnar 13 and 3 doses of diphteria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b antigens in infancy

⁃ Specifically for infants:

⁃ \- Aged 42 to 89 days on the day of the first study visit

Locations
United States
Arkansas
The Children's Clinic Of Jonesboro PA Site Number : 8400143
Jonesboro
California
Southland Clinical Research Center Site Number : 8400040
Bellflower
Joint Clinical Trials Huntington Park Site Number : 8400030
Huntington Park
Matrix Clinical Research Huntington Park Site Number : 8400058
Huntington Park
Matrix Clinical Research Site Number : 8400059
Los Angeles
Orange County Research Institute Site Number : 8400060
Ontario
California Research Foundation Site Number : 8400052
San Diego
Washington, D.c.
Meridian Clinical Research Washington DC Site Number : 8400119
Washington D.c.
Florida
International Research Partners, LLC Site Number : 8400077
Doral
Homestead Medical Clinic, P.A. Site Number : 8400032
Homestead
Amber Clinical Research, LLC Site Number : 8400019
Miami
Dade Research Center Site Number : 8400122
Miami
Miami Clinical Research Site Number : 8400020
Miami
Jedidiah Clinical Research Site Number : 8400049
Tampa
Georgia
Javara Albany Site Number : 8400140
Albany
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062
Columbus
Javara Fayetteville Site Number : 8400139
Fayetteville
Dumog Research Site Number : 8400134
Smyrna
Idaho
Bingham Memorial Hospital Site Number : 8400067
Blackfoot
Leavitt Clinical Research Site Number : 8400127
Idaho Falls
Kansas
Hutchinson Clinic Site Number : 8400074
Hutchinson
Kentucky
Qualmedica Research, LLC Site Number : 8400084
Bowling Green
Michael W. Simon, MD, PSC Site Number : 8400002
Lexington
Louisiana
Meridian Clinical Research, LLC Site Number : 8400112
Baton Rouge
Benchmark Research Site Number : 8400012
Covington
Velocity Clinical Research Lafayette Site Number : 8400132
Lafayette
Maryland
Javara Annapolis Site Number : 8400137
Annapolis
Javara Chevy Chase Site Number : 8400138
Chevy Chase
Missouri
Children's Mercy Hospital Site Number : 8400008
Kansas City
Montana
Boeson Research Site Number : 8400004
Missoula
North Carolina
Atrium Health Site Number : 8400124
Charlotte
Ardmore Medical Research Site Number : 8400043
Winston-salem
Nebraska
Meridian Clinical Research Site Number : 8400102
Grand Island
Lincoln Pediatric Group Site Number : 8400125
Lincoln
Pediatric Infectious Diseases Research Site Number : 8400104
Omaha
Ohio
Pediatric Associates of Mt. Carmel Site Number : 8400005
Cincinnati
South Carolina
Cheraw Pediatrics Site Number : 8400017
Cheraw
Tribe Clinical Research Site Number : 8400025
Greenville
Texas
Javara Dallas Site Number : 8400135
Dallas
Pininos Pediatric Services Site Number : 8400121
El Paso
North Texas Clinical Trials Site Number : 8400015
Fort Worth
Houston Clinical Research Associates Site Number : 8400023
Houston
FMC Science, LLC Site Number : 8400086
Lampasas
DCOL Center for Clinical Research Site Number : 8400107
Longview
Biopharma Informatic Site Number : 8400066
Mcallen
Benchmark Research San Antonio Site Number : 8400129
San Antonio
Sun Research Institute Site Number : 8400011
San Antonio
Tekton Research Site Number : 8400076
San Antonio
Washington
MultiCare Institute for Research & Innovation Site Number : 8400024
Spokane
Other Locations
Canada
Investigational Site Number : 1240001
Halifax
Investigational Site Number : 1240006
Hamilton
Investigational Site Number : 1240002
Vancouver
Honduras
Investigational Site Number : 3400002
Municipio Del Distrito Central
Investigational Site Number : 3400001
San Pedro Sula
Puerto Rico
Investigational Site Number : 6300002
Bayamón
Investigational Site Number : 6300004
Guayama
Investigational Site Number : 6300001
San Juan
Time Frame
Start Date: 2020-05-22
Completion Date: 2023-08-10
Participants
Target number of participants: 852
Treatments
Experimental: Group 1
One dose of SP0202-IIb and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Experimental: Group 2
One dose of SP0202-VI and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Experimental: Group 3
One dose of SP0202-VII and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Active_comparator: Group 4
One dose of Prevnar 13 and one dose of DTaP-IPV// Hib vaccine in toddlers aged 12-15 months who have previously received the 3-dose primary series of Prevnar13
Experimental: Group 5
Four doses of SP0202-IIb at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Experimental: Group 6
Four doses of SP0202-VI at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Experimental: Group 7
Four doses of SP0202-VII at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Active_comparator: Group 8
Four doses of Prevnar 13 at 2, 4, 6 and 12-15 months Routine pediatric vaccines: DTaP-IPV// Hib vaccine, rotavirus vaccine at 2, 4, 6 months; MMR vaccine and varicella vaccine at 12-15 months Hepatitis B vaccine at 2, 4, 6 months, as applicable
Sponsors
Leads: Sanofi Pasteur, a Sanofi Company

This content was sourced from clinicaltrials.gov