Pneumococcal ImmunisationPhase 2NCT04398706
Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
A Phase 2 study testing Pneumococcal Conjugate Vaccine formulation 1, Pneumococcal Conjugate Vaccine formulation 2 and Pneumococcal Conjugate Vaccine formulation 3 in people with Pneumococcal Immunisation and Diphtheria Immunisation, run by Sanofi Pasteur, a Sanofi Company at 57 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 42 days to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation
- What is being tested?
- Pneumococcal Conjugate Vaccine formulation 1, Pneumococcal Conjugate Vaccine formulation 2 and Pneumococcal Conjugate Vaccine formulation 3
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 57 sitesin 4 countries
- Study dates
- 22 May 2020to 10 Aug 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 days to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
57 sites in 4 countries.
57 sites in 4 countries
United States49 sites
Javara Albany Site Number : 8400140
Albany, Georgia, 31707
Javara Annapolis Site Number : 8400137
Annapolis, Maryland, 21401
Meridian Clinical Research, LLC Site Number : 8400112
Baton Rouge, Louisiana, 70806
Southland Clinical Research Center Site Number : 8400040
Bellflower, California, 90706
Bingham Memorial Hospital Site Number : 8400067
Blackfoot, Idaho, 83221
Qualmedica Research, LLC Site Number : 8400084
Bowling Green, Kentucky, 42101
Atrium Health Site Number : 8400124
Charlotte, North Carolina, 28204
Cheraw Pediatrics Site Number : 8400017
Cheraw, South Carolina, 29520
Javara Chevy Chase Site Number : 8400138
Chevy Chase, Maryland, 20815
Pediatric Associates of Mt. Carmel Site Number : 8400005
Cincinnati, Ohio, 45245
Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062
Columbus, Georgia, 31904
Benchmark Research Site Number : 8400012
Covington, Louisiana, 70433
Javara Dallas Site Number : 8400135
Dallas, Texas, 75230
International Research Partners, LLC Site Number : 8400077
Doral, Florida, 33122
Pininos Pediatric Services Site Number : 8400121
El Paso, Texas, 79902
Javara Fayetteville Site Number : 8400139
Fayetteville, Georgia, 30214
North Texas Clinical Trials Site Number : 8400015
Fort Worth, Texas, 76104
Meridian Clinical Research Site Number : 8400102
Grand Island, Nebraska, 68803
Tribe Clinical Research Site Number : 8400025
Greenville, South Carolina, 29607
Homestead Medical Clinic, P.A. Site Number : 8400032
Homestead, Florida, 33030
Houston Clinical Research Associates Site Number : 8400023
Houston, Texas, 77090
Joint Clinical Trials Huntington Park Site Number : 8400030
Huntington Park, California, 90255
Matrix Clinical Research Huntington Park Site Number : 8400058
Huntington Park, California, 90255
Hutchinson Clinic Site Number : 8400074
Hutchinson, Kansas, 67502
Leavitt Clinical Research Site Number : 8400127
Idaho Falls, Idaho, 83404
The Children's Clinic Of Jonesboro PA Site Number : 8400143
Jonesboro, Arkansas, 72401
Children's Mercy Hospital Site Number : 8400008
Kansas City, Missouri, 64108
Velocity Clinical Research Lafayette Site Number : 8400132
Lafayette, Louisiana, 70508
FMC Science, LLC Site Number : 8400086
Lampasas, Texas, 76550-1820
Michael W. Simon, MD, PSC Site Number : 8400002
Lexington, Kentucky, 40517
Lincoln Pediatric Group Site Number : 8400125
Lincoln, Nebraska, 68516
DCOL Center for Clinical Research Site Number : 8400107
Longview, Texas, 75605
Matrix Clinical Research Site Number : 8400059
Los Angeles, California, 90057
Biopharma Informatic Site Number : 8400066
McAllen, Texas, 78503
Dade Research Center Site Number : 8400122
Miami, Florida, 33135
Miami Clinical Research Site Number : 8400020
Miami, Florida, 33155
Amber Clinical Research, LLC Site Number : 8400019
Miami, Florida, 33164
Boeson Research Site Number : 8400004
Missoula, Montana, 59804
Pediatric Infectious Diseases Research Site Number : 8400104
Omaha, Nebraska, 68131
Orange County Research Institute Site Number : 8400060
Ontario, California, 91762
Benchmark Research San Antonio Site Number : 8400129
San Antonio, Texas, 78201
Sun Research Institute Site Number : 8400011
San Antonio, Texas, 78205
Tekton Research Site Number : 8400076
San Antonio, Texas, 78244
California Research Foundation Site Number : 8400052
San Diego, California, 92123-1881
Dumog Research Site Number : 8400134
Smyrna, Georgia, 30080
MultiCare Institute for Research & Innovation Site Number : 8400024
Spokane, Washington, 99202
Jedidiah Clinical Research Site Number : 8400049
Tampa, Florida, 33617
Meridian Clinical Research Washington DC Site Number : 8400119
Washington D.C., District of Columbia, 20016
Ardmore Medical Research Site Number : 8400043
Winston-Salem, North Carolina, 27103
Canada3 sites
Investigational Site Number : 1240001
Halifax, Nova Scotia, B3K6R8
Investigational Site Number : 1240006
Hamilton, Ontario, L8M 1K7
Investigational Site Number : 1240002
Vancouver, British Columbia, V5Z4H4
Puerto Rico3 sites
Investigational Site Number : 6300002
Bayamón, 00961
Investigational Site Number : 6300004
Guayama, 000784
Investigational Site Number : 6300001
San Juan, 00935
Honduras2 sites
Investigational Site Number : 3400002
Municipio Del Distrito Central, 11101
Investigational Site Number : 3400001
San Pedro Sula, 21104
About this study
Official title: 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)
Read more
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])
Read the 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.
- Conditions
- Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation, Pertussis Immunisation, Hepatitis B Immunisation, Haemophilus Influenzae Type b Immunisation
- Being tested
- Pneumococcal Conjugate Vaccine formulation 1, Pneumococcal Conjugate Vaccine formulation 2, Pneumococcal Conjugate Vaccine formulation 3, Varicella Virus Vaccine Live, Measles, Mumps, and Rubella Virus Vaccine Live
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal Conjugate Vaccine formulation 1Biological
Also called SP0202-IIb
Pharmaceutical form:liquid Route of administration: intramuscular
Pneumococcal Conjugate Vaccine formulation 2Biological
Also called SP0202-VI
Pharmaceutical form:liquid Route of administration: intramuscular
Pneumococcal Conjugate Vaccine formulation 3Biological
Also called SP0202-VII
Pharmaceutical form:liquid Route of administration: intramuscular
Varicella Virus Vaccine LiveBiological
Also called Varicella vaccine, VARIVAX®
Pharmaceutical form:liquid Route of administration: subcutaneous
Measles, Mumps, and Rubella Virus Vaccine LiveBiological
Also called MMR vaccine, M-M-R ®II
Pharmaceutical form:liquid Route of administration: subcutaneous
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Biological
Also called Prevnar 13®
Pharmaceutical form:liquid Route of administration: intramuscular
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)Biological
Also called DTaP-IPV// Hib vaccine, Pentacel®
Pharmaceutical form:liquid Route of administration: intramuscular
Rotavirus Vaccine, Live, Oral, PentavalentBiological
Also called Rotavirus vaccine, RotaTeq
Pharmaceutical form:liquid Route of administration: oral
Hepatitis B Vaccine* [Recombinant] *as applicableBiological
Also called Hepatitis B vaccine, ENGERIX-B®
Pharmaceutical form:liquid Route of administration: intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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 Receives: Biological: Pneumococcal Conjugate Vaccine formulation 1; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) |
| Group 2 | Experimental | 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 Receives: Biological: Pneumococcal Conjugate Vaccine formulation 2; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) |
| Group 3 | Experimental | 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 Receives: Biological: Pneumococcal Conjugate Vaccine formulation 3; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) |
| Group 4 | Active comparator | 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 Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) |
| Group 5 | Experimental | 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 Receives: Biological: Pneumococcal Conjugate Vaccine formulation 1; Biological: Varicella Virus Vaccine Live; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate); Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable |
| Group 6 | Experimental | 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 Receives: Biological: Pneumococcal Conjugate Vaccine formulation 2; Biological: Varicella Virus Vaccine Live; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate); Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable |
| Group 7 | Experimental | 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 Receives: Biological: Pneumococcal Conjugate Vaccine formulation 3; Biological: Varicella Virus Vaccine Live; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate); Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable |
| Group 8 | Active comparator | 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 Receives: Biological: Varicella Virus Vaccine Live; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate); Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 330
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 330
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start22 May 2020
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal ImmunisationStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398706
- Sponsor's protocol ID
- PSK00008
- Other IDs
- U1111-1238-1638, PSK00008
- Status last verified
- Sep 2025
- First submitted
- 18 May 2020
- Last updated
- 8 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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