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: Recruiting
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: Accepts Healthy Volunteers
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
Recruiting
Jonesboro
California
Southland Clinical Research Center-Site Number:8400040
Recruiting
Bellflower
Join Clinical Trials Huntington Park-Site Number:8400030
Recruiting
Huntington Park
Matrix Clinical Research Huntington Park-Site Number:8400058
Recruiting
Huntington Park
Matrix Clinical Research-Site Number:8400059
Recruiting
Los Angeles
Orange County Research Institute-Site Number:8400060
Recruiting
Ontario
California Research Foundation-Site Number:8400052
Recruiting
San Diego
Washington, D.c.
Meridian Clinical Research Washington DC-Site Number:8400119
Recruiting
Washington
Florida
International Research Partners, LLC-Site Number:8400077
Recruiting
Doral
Homestead Medical Clinic, P.A.-Site Number:8400032
Recruiting
Homestead
Amber Clinical Research, LLC-Site Number:8400019
Recruiting
Miami
Dade Research Center-Site Number:8400122
Recruiting
Miami
Miami Clinical Research-Site Number:8400020
Recruiting
Miami
Jedidiah Clinical Research-Site Number:8400049
Recruiting
Tampa
Georgia
Javara Albany-Site Number:8400140
Recruiting
Albany
Centricity Research Talbotton - DBA IACT Health Research at Talbotton-Site Number:8400062
Recruiting
Columbus
Javara Fayetteville-Site Number:8400139
Recruiting
Fayetteville
Dumog Research-Site Number:8400134
Recruiting
Smyrna
Idaho
Bingham Memorial Hospital-Site Number:8400067
Recruiting
Blackfoot
Leavitt Clinical Research-Site Number:8400127
Recruiting
Idaho Falls
Kansas
Hutchinson Clinic-Site Number:8400074
Recruiting
Hutchinson
Kentucky
Qualmedica Research, LLC-Site Number:8400084
Recruiting
Bowling Green
Michael W. Simon, MD, PSC-Site Number:8400002
Recruiting
Lexington
Louisiana
Meridian Clinical Research, LLC-Site Number:8400112
Recruiting
Baton Rouge
Benchmark Research-Site Number:8400012
Active, not recruiting
Covington
MedPharmics, LLC-Site Number:8400132
Active, not recruiting
Lafayette
Maryland
Javara Annapolis-Site Number:8400137
Recruiting
Annapolis
Javara Chevy Chase-Site Number:8400138
Recruiting
Chevy Chase
Missouri
Children's Mercy Hospital-Site Number:8400008
Recruiting
Kansas City
Montana
Boeson Research-Site Number:8400004
Recruiting
Missoula
North Carolina
Atrium Health-Site Number:8400124
Recruiting
Charlotte
Ardmore Medical Research-Site Number:8400043
Recruiting
Winston-salem
Nebraska
Meridian Clinical Research-Site Number:8400102
Recruiting
Grand Island
Lincoln Pediatric Group-Site Number:8400125
Recruiting
Lincoln
Pediatric Infectious Diseases Research-Site Number:8400104
Recruiting
Omaha
Ohio
Pediatric Associates of Mt. Carmel-Site Number:8400005
Recruiting
Cincinnati
South Carolina
Cheraw Pediatrics-Site Number:8400017
Completed
Cheraw
Tribe Clinical Research-Site Number:8400025
Recruiting
Greenville
Texas
Javara Dallas-Site Number:8400135
Active, not recruiting
Dallas
Pininos Pediatric Services-Site Number:8400121
Recruiting
El Paso
North Texas Clinical Trials-Site Number:8400015
Recruiting
Fort Worth
Houston Clinical Research Associates-Site Number:8400023
Recruiting
Houston
FMC Science, LLC-Site Number:8400086
Recruiting
Lampasas
DCOL Center for Clinical Research-Site Number:8400107
Recruiting
Longview
Biopharma Informatic-Site Number:8400066
Recruiting
Mcallen
Benchmark Research San Antonio-Site Number:8400129
Active, not recruiting
San Antonio
Sun Research Institute-Site Number:8400011
Recruiting
San Antonio
Tekton Research-Site Number:8400076
Recruiting
San Antonio
Washington
MultiCare Institute for Research & Innovation-Site Number:8400024
Recruiting
Spokane
Other Locations
Canada
Investigational Site Number :1240001
Recruiting
Halifax
Investigational Site Number :1240006
Recruiting
Hamilton
Investigational Site Number :1240002
Recruiting
Vancouver
Honduras
Investigational Site Number :3400002
Recruiting
Municipio Del Distrito Central
Investigational Site Number :3400001
Recruiting
San Pedro Sula
Puerto Rico
Investigational Site Number :6300002
Recruiting
Bayamón
Investigational Site Number :6300004
Recruiting
Guayama
Investigational Site Number :6300001
Recruiting
San Juan
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: May 22, 2020
Estimated Completion Date: October 13, 2023
Participants
Target number of participants: 840
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

This content was sourced from clinicaltrials.gov

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