Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
NCT ID: NCT04398706
Last Updated: 2025-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
852 participants
INTERVENTIONAL
2020-05-22
2023-08-10
Brief Summary
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* 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\])
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
* 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
Study Groups
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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
Pneumococcal Conjugate Vaccine formulation 1
Pharmaceutical form:liquid Route of administration: intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
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
Pneumococcal Conjugate Vaccine formulation 2
Pharmaceutical form:liquid Route of administration: intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
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
Pneumococcal Conjugate Vaccine formulation 3
Pharmaceutical form:liquid Route of administration: intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
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
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Pharmaceutical form:liquid Route of administration: intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
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
Pneumococcal Conjugate Vaccine formulation 1
Pharmaceutical form:liquid Route of administration: intramuscular
Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
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
Pneumococcal Conjugate Vaccine formulation 2
Pharmaceutical form:liquid Route of administration: intramuscular
Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
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
Pneumococcal Conjugate Vaccine formulation 3
Pharmaceutical form:liquid Route of administration: intramuscular
Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
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
Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Pharmaceutical form:liquid Route of administration: intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
Interventions
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Pneumococcal Conjugate Vaccine formulation 1
Pharmaceutical form:liquid Route of administration: intramuscular
Pneumococcal Conjugate Vaccine formulation 2
Pharmaceutical form:liquid Route of administration: intramuscular
Pneumococcal Conjugate Vaccine formulation 3
Pharmaceutical form:liquid Route of administration: intramuscular
Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Pharmaceutical form:liquid Route of administration: intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
42 Days
15 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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The Children's Clinic Of Jonesboro PA Site Number : 8400143
Jonesboro, Arkansas, United States
Southland Clinical Research Center Site Number : 8400040
Bellflower, California, United States
Joint Clinical Trials Huntington Park Site Number : 8400030
Huntington Park, California, United States
Matrix Clinical Research Huntington Park Site Number : 8400058
Huntington Park, California, United States
Matrix Clinical Research Site Number : 8400059
Los Angeles, California, United States
Orange County Research Institute Site Number : 8400060
Ontario, California, United States
California Research Foundation Site Number : 8400052
San Diego, California, United States
Meridian Clinical Research Washington DC Site Number : 8400119
Washington D.C., District of Columbia, United States
International Research Partners, LLC Site Number : 8400077
Doral, Florida, United States
Homestead Medical Clinic, P.A. Site Number : 8400032
Homestead, Florida, United States
Dade Research Center Site Number : 8400122
Miami, Florida, United States
Miami Clinical Research Site Number : 8400020
Miami, Florida, United States
Amber Clinical Research, LLC Site Number : 8400019
Miami, Florida, United States
Jedidiah Clinical Research Site Number : 8400049
Tampa, Florida, United States
Javara Albany Site Number : 8400140
Albany, Georgia, United States
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062
Columbus, Georgia, United States
Javara Fayetteville Site Number : 8400139
Fayetteville, Georgia, United States
Dumog Research Site Number : 8400134
Smyrna, Georgia, United States
Bingham Memorial Hospital Site Number : 8400067
Blackfoot, Idaho, United States
Leavitt Clinical Research Site Number : 8400127
Idaho Falls, Idaho, United States
Hutchinson Clinic Site Number : 8400074
Hutchinson, Kansas, United States
Qualmedica Research, LLC Site Number : 8400084
Bowling Green, Kentucky, United States
Michael W. Simon, MD, PSC Site Number : 8400002
Lexington, Kentucky, United States
Meridian Clinical Research, LLC Site Number : 8400112
Baton Rouge, Louisiana, United States
Benchmark Research Site Number : 8400012
Covington, Louisiana, United States
Velocity Clinical Research Lafayette Site Number : 8400132
Lafayette, Louisiana, United States
Javara Annapolis Site Number : 8400137
Annapolis, Maryland, United States
Javara Chevy Chase Site Number : 8400138
Chevy Chase, Maryland, United States
Children's Mercy Hospital Site Number : 8400008
Kansas City, Missouri, United States
Boeson Research Site Number : 8400004
Missoula, Montana, United States
Meridian Clinical Research Site Number : 8400102
Grand Island, Nebraska, United States
Lincoln Pediatric Group Site Number : 8400125
Lincoln, Nebraska, United States
Pediatric Infectious Diseases Research Site Number : 8400104
Omaha, Nebraska, United States
Atrium Health Site Number : 8400124
Charlotte, North Carolina, United States
Ardmore Medical Research Site Number : 8400043
Winston-Salem, North Carolina, United States
Pediatric Associates of Mt. Carmel Site Number : 8400005
Cincinnati, Ohio, United States
Cheraw Pediatrics Site Number : 8400017
Cheraw, South Carolina, United States
Tribe Clinical Research Site Number : 8400025
Greenville, South Carolina, United States
Javara Dallas Site Number : 8400135
Dallas, Texas, United States
Pininos Pediatric Services Site Number : 8400121
El Paso, Texas, United States
North Texas Clinical Trials Site Number : 8400015
Fort Worth, Texas, United States
Houston Clinical Research Associates Site Number : 8400023
Houston, Texas, United States
FMC Science, LLC Site Number : 8400086
Lampasas, Texas, United States
DCOL Center for Clinical Research Site Number : 8400107
Longview, Texas, United States
Biopharma Informatic Site Number : 8400066
McAllen, Texas, United States
Benchmark Research San Antonio Site Number : 8400129
San Antonio, Texas, United States
Sun Research Institute Site Number : 8400011
San Antonio, Texas, United States
Tekton Research Site Number : 8400076
San Antonio, Texas, United States
MultiCare Institute for Research & Innovation Site Number : 8400024
Spokane, Washington, United States
Investigational Site Number : 1240002
Vancouver, British Columbia, Canada
Investigational Site Number : 1240001
Halifax, Nova Scotia, Canada
Investigational Site Number : 1240006
Hamilton, Ontario, Canada
Investigational Site Number : 3400002
Municipio Del Distrito Central, , Honduras
Investigational Site Number : 3400001
San Pedro Sula, , Honduras
Investigational Site Number : 6300002
Bayamón, , Puerto Rico
Investigational Site Number : 6300004
Guayama, , Puerto Rico
Investigational Site Number : 6300001
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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PSK00008 Plain Language Results Summary
Other Identifiers
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U1111-1238-1638
Identifier Type: REGISTRY
Identifier Source: secondary_id
PSK00008
Identifier Type: OTHER
Identifier Source: secondary_id
PSK00008
Identifier Type: -
Identifier Source: org_study_id
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