Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
2 other identifiers
interventional
852
4 countries
57
Brief 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\])
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2020
Typical duration for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedStudy Start
First participant enrolled
May 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2023
CompletedResults Posted
Study results publicly available
November 12, 2024
CompletedSeptember 8, 2025
September 1, 2025
3.2 years
May 18, 2020
August 9, 2024
September 4, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
Number of Participants With Immediate Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination and included both serious adverse events (SAEs) and non-serious unsolicited AEs.
Up to 30 minutes after each vaccination
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB and were considered to be related to the product administered. An injection site reaction was an adverse reaction at and around the injection site which were commonly inflammatory reactions. Solicited injection site reactions included tenderness, erythema and swelling around the injection site and were planned to be collected and reported for SP0202/Prevnar 13 for both toddlers and infants.
Up to 7 days after each vaccination
Number of Participants With Solicited Systemic Reactions
A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.
Up to 7 days after each vaccination
Number of Participants With Unsolicited AEs
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which did not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs included both SAEs and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.
Up to 30 days after each vaccination
Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The following AE were captured as AESI throughout the study: Anaphylaxis defined as per the Brighton collaboration case definition, convulsions including febrile convulsions, hypotonic-hyporesponsive episode and apnea. Reported AEs for each arm were presented as pre-specified in protocol.
From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days
For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose
The GMCs for serotype specific pneumococcal IgG antibodies were measured using pneumococcal capsular polysaccharide-electro-chemiluminescent assay (PnPS-ECL), a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 30
For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3
Percentage of infants with serotype specific IgG concentration \>=0.35 mcg/mL for each pneumococcal serotype included in the SP0202 formulations were measured using ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 150
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3
The GMCs for serotype-specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 150
For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4
The GMCs for serotype specific pneumococcal IgG antibodies were measured using PnPS-ECL, a multiplexed serological assay which allows for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
Day 330
Secondary Outcomes (9)
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose
Day 30
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3
Day 150
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4
Day 330
For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3
Day 150
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3
Day 150
- +4 more secondary outcomes
Study Arms (8)
Group 1
EXPERIMENTALOne 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
Group 2
EXPERIMENTALOne 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
Group 3
EXPERIMENTALOne 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
Group 4
ACTIVE COMPARATOROne 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
Group 5
EXPERIMENTALFour 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
Group 6
EXPERIMENTALFour 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
Group 7
EXPERIMENTALFour 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
Group 8
ACTIVE COMPARATORFour 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
Interventions
Pharmaceutical form:liquid Route of administration: intramuscular
Pharmaceutical form:liquid Route of administration: intramuscular
Pharmaceutical form:liquid Route of administration: intramuscular
Pharmaceutical form:liquid Route of administration: subcutaneous
Pharmaceutical form:liquid Route of administration: subcutaneous
Pharmaceutical form:liquid Route of administration: intramuscular
Pharmaceutical form:liquid Route of administration: oral
Pharmaceutical form:liquid Route of administration: intramuscular
Pharmaceutical form:liquid Route of administration: intramuscular
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Toddlers and infants
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
- Blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
- Active tuberculosis
- History of S. pneumoniae infection or disease, confirmed either serologically or microbiologically
- History of any neurologic disorder, including any seizures and progressive neurologic disorders
- History of Guillain-Barré syndrome
- Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
- Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and know congenital or genetic diseases) that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
- In an emergency setting, or hospitalized involuntarily
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C / ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or until 3 days after the febrile event has resolved
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
The Children's Clinic Of Jonesboro PA Site Number : 8400143
Jonesboro, Arkansas, 72401, United States
Southland Clinical Research Center Site Number : 8400040
Bellflower, California, 90706, United States
Joint Clinical Trials Huntington Park Site Number : 8400030
Huntington Park, California, 90255, United States
Matrix Clinical Research Huntington Park Site Number : 8400058
Huntington Park, California, 90255, United States
Matrix Clinical Research Site Number : 8400059
Los Angeles, California, 90057, United States
Orange County Research Institute Site Number : 8400060
Ontario, California, 91762, United States
California Research Foundation Site Number : 8400052
San Diego, California, 92123-1881, United States
Meridian Clinical Research Washington DC Site Number : 8400119
Washington D.C., District of Columbia, 20016, United States
International Research Partners, LLC Site Number : 8400077
Doral, Florida, 33122, United States
Homestead Medical Clinic, P.A. Site Number : 8400032
Homestead, Florida, 33030, United States
Dade Research Center Site Number : 8400122
Miami, Florida, 33135, United States
Miami Clinical Research Site Number : 8400020
Miami, Florida, 33155, United States
Amber Clinical Research, LLC Site Number : 8400019
Miami, Florida, 33164, United States
Jedidiah Clinical Research Site Number : 8400049
Tampa, Florida, 33617, United States
Javara Albany Site Number : 8400140
Albany, Georgia, 31707, United States
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062
Columbus, Georgia, 31904, United States
Javara Fayetteville Site Number : 8400139
Fayetteville, Georgia, 30214, United States
Dumog Research Site Number : 8400134
Smyrna, Georgia, 30080, United States
Bingham Memorial Hospital Site Number : 8400067
Blackfoot, Idaho, 83221, United States
Leavitt Clinical Research Site Number : 8400127
Idaho Falls, Idaho, 83404, United States
Hutchinson Clinic Site Number : 8400074
Hutchinson, Kansas, 67502, United States
Qualmedica Research, LLC Site Number : 8400084
Bowling Green, Kentucky, 42101, United States
Michael W. Simon, MD, PSC Site Number : 8400002
Lexington, Kentucky, 40517, United States
Meridian Clinical Research, LLC Site Number : 8400112
Baton Rouge, Louisiana, 70806, United States
Benchmark Research Site Number : 8400012
Covington, Louisiana, 70433, United States
Velocity Clinical Research Lafayette Site Number : 8400132
Lafayette, Louisiana, 70508, United States
Javara Annapolis Site Number : 8400137
Annapolis, Maryland, 21401, United States
Javara Chevy Chase Site Number : 8400138
Chevy Chase, Maryland, 20815, United States
Children's Mercy Hospital Site Number : 8400008
Kansas City, Missouri, 64108, United States
Boeson Research Site Number : 8400004
Missoula, Montana, 59804, United States
Meridian Clinical Research Site Number : 8400102
Grand Island, Nebraska, 68803, United States
Lincoln Pediatric Group Site Number : 8400125
Lincoln, Nebraska, 68516, United States
Pediatric Infectious Diseases Research Site Number : 8400104
Omaha, Nebraska, 68131, United States
Atrium Health Site Number : 8400124
Charlotte, North Carolina, 28204, United States
Ardmore Medical Research Site Number : 8400043
Winston-Salem, North Carolina, 27103, United States
Pediatric Associates of Mt. Carmel Site Number : 8400005
Cincinnati, Ohio, 45245, United States
Cheraw Pediatrics Site Number : 8400017
Cheraw, South Carolina, 29520, United States
Tribe Clinical Research Site Number : 8400025
Greenville, South Carolina, 29607, United States
Javara Dallas Site Number : 8400135
Dallas, Texas, 75230, United States
Pininos Pediatric Services Site Number : 8400121
El Paso, Texas, 79902, United States
North Texas Clinical Trials Site Number : 8400015
Fort Worth, Texas, 76104, United States
Houston Clinical Research Associates Site Number : 8400023
Houston, Texas, 77090, United States
FMC Science, LLC Site Number : 8400086
Lampasas, Texas, 76550-1820, United States
DCOL Center for Clinical Research Site Number : 8400107
Longview, Texas, 75605, United States
Biopharma Informatic Site Number : 8400066
McAllen, Texas, 78503, United States
Benchmark Research San Antonio Site Number : 8400129
San Antonio, Texas, 78201, United States
Sun Research Institute Site Number : 8400011
San Antonio, Texas, 78205, United States
Tekton Research Site Number : 8400076
San Antonio, Texas, 78244, United States
MultiCare Institute for Research & Innovation Site Number : 8400024
Spokane, Washington, 99202, United States
Investigational Site Number : 1240002
Vancouver, British Columbia, V5Z4H4, Canada
Investigational Site Number : 1240001
Halifax, Nova Scotia, B3K6R8, Canada
Investigational Site Number : 1240006
Hamilton, Ontario, L8M 1K7, Canada
Investigational Site Number : 3400002
Municipio Del Distrito Central, 11101, Honduras
Investigational Site Number : 3400001
San Pedro Sula, 21104, Honduras
Investigational Site Number : 6300002
Bayamón, 00961, Puerto Rico
Investigational Site Number : 6300004
Guayama, 000784, Puerto Rico
Investigational Site Number : 6300001
San Juan, 00935, Puerto Rico
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study will be performed in a modified double-blind fashion: * Investigators and study staff who conduct the safety assessment and the participant will not know which vaccine is administered * Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation will know which vaccine is administered This study will be observer-blinded between any SP0202 formulation and Prevnar 13 and double-blind across the 3 SP0202 formulations
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 21, 2020
Study Start
May 22, 2020
Primary Completion
August 10, 2023
Study Completion
August 10, 2023
Last Updated
September 8, 2025
Results First Posted
November 12, 2024
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org