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

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])

Study Overview

• Status: Completed
• Conditions: Pertussis Immunisation; Diphtheria Immunisation; Tetanus Immunisation; Pneumococcal Immunisation; Hepatitis B Immunisation; Haemophilus Influenzae Type b Immunisation; Polio Immunisation; Measles Immunisation; Rubella Immunisation; Varicella Immunisation; Mumps Immunisation
• Intervention / Treatment: Biological: Pneumococcal Conjugate Vaccine formulation 1; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate); Biological: Pneumococcal Conjugate Vaccine formulation 2; Biological: Pneumococcal Conjugate Vaccine formulation 3; Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]; Biological: Varicella Virus Vaccine Live; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable

Detailed Description

For toddlers, the duration of each participant's participation in the study will be approximately 6 months for subjects enrolled in Groups 1, 2, 3, and 4.

For infants, the duration of each participant's participation in the study will be approximately 16 to 19 months for subjects enrolled in Groups 5, 6, 7, and 8.

• Study Type: Interventional
• Enrollment (Actual): 852
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4H4
      • Investigational Site Number : 1240002
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K6R8
      • Investigational Site Number : 1240001
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1K7
      • Investigational Site Number : 1240006
• Honduras
  • Municipio Del Distrito Central, Honduras, 11101
    • Investigational Site Number : 3400002
  • San Pedro Sula, Honduras, 21104
    • Investigational Site Number : 3400001
• Puerto Rico
  • Bayamón, Puerto Rico, 00961
    • Investigational Site Number : 6300002
  • Guayama, Puerto Rico, 000784
    • Investigational Site Number : 6300004
  • San Juan, Puerto Rico, 00935
    • Investigational Site Number : 6300001
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic Of Jonesboro PA Site Number : 8400143
  • California
    • Bellflower, California, United States, 90706
      • Southland Clinical Research Center Site Number : 8400040
    • Huntington Park, California, United States, 90255
      • Joint Clinical Trials Huntington Park Site Number : 8400030
    • Huntington Park, California, United States, 90255
      • Matrix Clinical Research Huntington Park Site Number : 8400058
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research Site Number : 8400059
    • Ontario, California, United States, 91762
      • Orange County Research Institute Site Number : 8400060
    • San Diego, California, United States, 92123-1881
      • California Research Foundation Site Number : 8400052
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Meridian Clinical Research Washington DC Site Number : 8400119
  • Florida
    • Doral, Florida, United States, 33122
      • International Research Partners, LLC Site Number : 8400077
    • Homestead, Florida, United States, 33030
      • Homestead Medical Clinic, P.A. Site Number : 8400032
    • Miami, Florida, United States, 33135
      • Dade Research Center Site Number : 8400122
    • Miami, Florida, United States, 33155
      • Miami Clinical Research Site Number : 8400020
    • Miami, Florida, United States, 33164
      • Amber Clinical Research, LLC Site Number : 8400019
    • Tampa, Florida, United States, 33617
      • Jedidiah Clinical Research Site Number : 8400049
  • Georgia
    • Albany, Georgia, United States, 31707
      • Javara Albany Site Number : 8400140
    • Columbus, Georgia, United States, 31904
      • Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062
    • Fayetteville, Georgia, United States, 30214
      • Javara Fayetteville Site Number : 8400139
    • Smyrna, Georgia, United States, 30080
      • Dumog Research Site Number : 8400134
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Bingham Memorial Hospital Site Number : 8400067
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research Site Number : 8400127
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Hutchinson Clinic Site Number : 8400074
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Qualmedica Research, LLC Site Number : 8400084
    • Lexington, Kentucky, United States, 40517
      • Michael W. Simon, MD, PSC Site Number : 8400002
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Meridian Clinical Research, LLC Site Number : 8400112
    • Covington, Louisiana, United States, 70433
      • Benchmark Research Site Number : 8400012
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research Lafayette Site Number : 8400132
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Javara Annapolis Site Number : 8400137
    • Chevy Chase, Maryland, United States, 20815
      • Javara Chevy Chase Site Number : 8400138
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital Site Number : 8400008
  • Montana
    • Missoula, Montana, United States, 59804
      • Boeson Research Site Number : 8400004
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research Site Number : 8400102
    • Lincoln, Nebraska, United States, 68516
      • Lincoln Pediatric Group Site Number : 8400125
    • Omaha, Nebraska, United States, 68131
      • Pediatric Infectious Diseases Research Site Number : 8400104
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health Site Number : 8400124
    • Winston-Salem, North Carolina, United States, 27103
      • Ardmore Medical Research Site Number : 8400043
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel Site Number : 8400005
  • South Carolina
    • Cheraw, South Carolina, United States, 29520
      • Cheraw Pediatrics Site Number : 8400017
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research Site Number : 8400025
  • Texas
    • Dallas, Texas, United States, 75230
      • Javara Dallas Site Number : 8400135
    • El Paso, Texas, United States, 79902
      • Pininos Pediatric Services Site Number : 8400121
    • Fort Worth, Texas, United States, 76104
      • North Texas Clinical Trials Site Number : 8400015
    • Houston, Texas, United States, 77090
      • Houston Clinical Research Associates Site Number : 8400023
    • Lampasas, Texas, United States, 76550-1820
      • FMC Science, LLC Site Number : 8400086
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research Site Number : 8400107
    • McAllen, Texas, United States, 78503
      • Biopharma Informatic Site Number : 8400066
    • San Antonio, Texas, United States, 78201
      • Benchmark Research San Antonio Site Number : 8400129
    • San Antonio, Texas, United States, 78205
      • Sun Research Institute Site Number : 8400011
    • San Antonio, Texas, United States, 78244
      • Tekton Research Site Number : 8400076
  • Washington
    • Spokane, Washington, United States, 99202
      • MultiCare Institute for Research & Innovation Site Number : 8400024

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria :

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

Exclusion criteria:

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
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study Specifically for toddlers
• Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 2), except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• History of diphtheria, tetanus, pertussis, poliomyelitis, and/or H. influenzae type b infection or disease Specifically for infants
• Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit (Visit 6), except for influenza vaccination or COVID-19 vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, and COVID-19 vaccines as applicable per local recommendations
• Receipt of immune globulins, blood or blood-derived products since birth.
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
• Previous vaccination against S. pneumoniae
• Previous vaccination against the following antigens: diphteria, tetanus, pertussis, H. influenzae type b, poliovirus, rotavirus, measles, mumps, rubella, and varicella
• Receipt of more than 1 previous dose of hepatitis B vaccine
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, varicella, H. influenzae type b, and/or rotavirus infection or disease
• History of intussusception

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Biological: Pneumococcal Conjugate Vaccine formulation 1; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: SP0202-IIb; 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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®
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	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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®; Biological: Pneumococcal Conjugate Vaccine formulation 2; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: SP0202-VI
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	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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®; Biological: Pneumococcal Conjugate Vaccine formulation 3; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: SP0202-VII
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	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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®; Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: Prevnar 13®
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	Biological: Pneumococcal Conjugate Vaccine formulation 1; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: SP0202-IIb; 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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®; Biological: Varicella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: Varicella vaccine, VARIVAX®; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: MMR vaccine, M-M-R ®II; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Pharmaceutical form:liquid Route of administration: oral; Other Names: Rotavirus vaccine, RotaTeq; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: Hepatitis B vaccine, ENGERIX-B®
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	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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®; Biological: Pneumococcal Conjugate Vaccine formulation 2; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: SP0202-VI; Biological: Varicella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: Varicella vaccine, VARIVAX®; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: MMR vaccine, M-M-R ®II; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Pharmaceutical form:liquid Route of administration: oral; Other Names: Rotavirus vaccine, RotaTeq; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: Hepatitis B vaccine, ENGERIX-B®
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	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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®; Biological: Pneumococcal Conjugate Vaccine formulation 3; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: SP0202-VII; Biological: Varicella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: Varicella vaccine, VARIVAX®; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: MMR vaccine, M-M-R ®II; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Pharmaceutical form:liquid Route of administration: oral; Other Names: Rotavirus vaccine, RotaTeq; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: Hepatitis B vaccine, ENGERIX-B®
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	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; Other Names: DTaP-IPV// Hib vaccine, Pentacel®; Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: Prevnar 13®; Biological: Varicella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: Varicella vaccine, VARIVAX®; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Pharmaceutical form:liquid Route of administration: subcutaneous; Other Names: MMR vaccine, M-M-R ®II; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Pharmaceutical form:liquid Route of administration: oral; Other Names: Rotavirus vaccine, RotaTeq; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable; Pharmaceutical form:liquid Route of administration: intramuscular; Other Names: Hepatitis B vaccine, ENGERIX-B®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose	The GMs for serotype specific OPA titers were measured using multiplex opsonophagocytic assay (MOPA) which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.	Day 30
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3	The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.	Day 150
For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4	The GMs for serotype specific OPA titers were measured using MOPA which is used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination.	Day 330
For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3	Anti-rotavirus IgA antibodies in human serum were measured by enzyme linked immunosorbent assay (ELISA). A reference standard assayed on each plate was used to calculate the amount of specific anti-rotavirus IgA antibody in the units assigned by the reference standard.	Day 150
For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3	Percentage of participants with toxoid concentration >=0.10 mcg/mL for diphtheria and tetanus and >=0.15 mcg/mL for PRP are presented. Anti-diphtheria and anti-tetanus concentrations were measured using electro-chemiluminescence assay (ECL) and anti-PRP concentrations were measured using a Farr-type radioimmunoassay.	Day 150
For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3	Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Response was defined as a titer >=8.	Day 150
For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3	Serum samples were collected for analysis by ECL to determine the GMC of antibodies to the following Pertussis antigens: Pertussis toxoid/toxin, Filamentous hemagglutinin, Pertactin and Fimbriae types 2 and 3.	Day 150
For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3	Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The VITROS ECi immunodiagnostic system uses an antibody mediated antigen sandwich formation to detect the presence of anti-hepatitis B surface antigen total immunoglobulin in human serum. The threshold presented is >=10 milli international units (mIU).	Day 150
For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4	Anti-measles antibodies were determined by bulk measles IgG enzyme immunoassay (EIA); anti-mumps antibodies by ELISA, anti-rubella antibodies by bulk rubella IgG EIA and anti-varicella antibodies were determined by glycoprotein ELISA to detect total IgG antibody to respective virus before and after vaccination with a virus-containing vaccine. Percentage of participants with anti-measles antibody concentrations >=255 mIU/mL, anti-mumps antibody concentrations: >=10 antibody units/mL, anti-rubella antibody concentrations >=10 IU/mL and anti-varicella concentrations >=5 units/mL is reported in this outcome measure.	Day 330

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• PSK00008 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Hepatitis; Togaviridae Infections; Rubivirus Infections; Hepatitis B; Diphtheria; Rubella; Biological Products; Complex Mixtures; Vaccines; Toxoids; Vaccines, Combined; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; Viral Hepatitis Vaccines; Herpesvirus Vaccines; Measles-Mumps-Rubella Vaccine; 13-valent pneumococcal vaccine; Tetanus Toxoid; Herpes Zoster Vaccine; Chickenpox Vaccine; CRM197 (non-toxic variant of diphtheria toxin); pentacel; Rotavirus Vaccines; RotaTeq; Hepatitis B Vaccines; Engerix-B
• Other Study ID Numbers: PSK00008 (Other Identifier: Sanofi Identifier); U1111-1238-1638 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No