Clinical trial NCT04398706: Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Official title: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Immunisation
Diphtheria Immunisation
Tetanus Immunisation
Pertussis Immunisation
Hepatitis B Immunisation
Haemophilus Influenzae Type b Immunisation
Polio Immunisation
Measles Immunisation
Rubella Immunisation
Varicella Immunisation
Mumps Immunisation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-05-21
Enrollment: 852
Sex: ALL
Minimum age (years): 42
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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\])

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Immediate Adverse Events (AEs)
timeFrame: Up to 30 minutes after each vaccination
measure: Number of Participants With Solicited Injection Site Reactions
timeFrame: Up to 7 days after each vaccination
measure: Number of Participants With Solicited Systemic Reactions
timeFrame: Up to 7 days after each vaccination
measure: Number of Participants With Unsolicited AEs
timeFrame: Up to 30 days after each vaccination
measure: Number of Participants With SAEs and Adverse Event of Special Interest (AESIs)
timeFrame: From first dose vaccine administration (Day 1) until 6 months after the last dose administration, 490 days
measure: For Toddlers: Serotype Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each Pneumococcal Serotype at 30 Days Post-Dose
timeFrame: Day 30
measure: For Infants: Percentage of Participants With Serotype Specific IgG Concentration >=0.35 mcg/mL 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days Post-Dose 4
timeFrame: Day 330
Secondary outcomes:
measure: For Toddlers: Serotype Specific OPA Geometric Mean Titers (GMTs) for Each Pneumococcal Serotype 30 Days Post-Dose
timeFrame: Day 30
measure: For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: Serotype Specific OPA GMTs for Each Pneumococcal Serotype 30 Days Post-Dose 4
timeFrame: Day 330
measure: For Infants: GMC of Anti-Rotavirus Serum Immunoglobulin A (IgA) Antibodies 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: Percentage of Participants With Antibody Responses to Poliovirus 1, 2 and 3 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: GMCs of Antibodies to Pertussis Antigens 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: Percentage of Participants With Antibody Responses to Hepatitis-B Antigens 30 Days Post-Dose 3
timeFrame: Day 150
measure: For Infants: Percentage of Participants With Antibody Responses to M-MRII and Varivax Antigens 30 Days Post-Dose 4
timeFrame: Day 330
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: The Children's Clinic Of Jonesboro PA Site Number : 8400143
state: Arkansas
city: Bellflower
country: United States
facility: Southland Clinical Research Center Site Number : 8400040
state: California
city: Huntington Park
country: United States
facility: Joint Clinical Trials Huntington Park Site Number : 8400030
state: California
city: Huntington Park
country: United States
facility: Matrix Clinical Research Huntington Park Site Number : 8400058
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research Site Number : 8400059
state: California
city: Ontario
country: United States
facility: Orange County Research Institute Site Number : 8400060
state: California
city: San Diego
country: United States
facility: California Research Foundation Site Number : 8400052
state: California
city: Washington
country: United States
facility: Meridian Clinical Research Washington DC Site Number : 8400119
state: District of Columbia
city: Doral
country: United States
facility: International Research Partners, LLC Site Number : 8400077
state: Florida
city: Homestead
country: United States
facility: Homestead Medical Clinic, P.A. Site Number : 8400032
state: Florida
city: Miami
country: United States
facility: Dade Research Center Site Number : 8400122
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research Site Number : 8400020
state: Florida
city: Miami
country: United States
facility: Amber Clinical Research, LLC Site Number : 8400019
state: Florida
city: Tampa
country: United States
facility: Jedidiah Clinical Research Site Number : 8400049
state: Florida
city: Albany
country: United States
facility: Javara Albany Site Number : 8400140
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400062
state: Georgia
city: Fayetteville
country: United States
facility: Javara Fayetteville Site Number : 8400139
state: Georgia
city: Smyrna
country: United States
facility: Dumog Research Site Number : 8400134
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital Site Number : 8400067
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research Site Number : 8400127
state: Idaho
city: Hutchinson
country: United States
facility: Hutchinson Clinic Site Number : 8400074
state: Kansas
city: Bowling Green
country: United States
facility: Qualmedica Research, LLC Site Number : 8400084
state: Kentucky
city: Lexington
country: United States
facility: Michael W. Simon, MD, PSC Site Number : 8400002
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC Site Number : 8400112
state: Louisiana
city: Covington
country: United States
facility: Benchmark Research Site Number : 8400012
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research Lafayette Site Number : 8400132
state: Louisiana
city: Annapolis
country: United States
facility: Javara Annapolis Site Number : 8400137
state: Maryland
city: Chevy Chase
country: United States
facility: Javara Chevy Chase Site Number : 8400138
state: Maryland
city: Kansas City
country: United States
facility: Children's Mercy Hospital Site Number : 8400008
state: Missouri
city: Missoula
country: United States
facility: Boeson Research Site Number : 8400004
state: Montana
city: Grand Island
country: United States
facility: Meridian Clinical Research Site Number : 8400102
state: Nebraska
city: Lincoln
country: United States
facility: Lincoln Pediatric Group Site Number : 8400125
state: Nebraska
city: Omaha
country: United States
facility: Pediatric Infectious Diseases Research Site Number : 8400104
state: Nebraska
city: Charlotte
country: United States
facility: Atrium Health Site Number : 8400124
state: North Carolina
city: Winston-Salem
country: United States
facility: Ardmore Medical Research Site Number : 8400043
state: North Carolina
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel Site Number : 8400005
state: Ohio
city: Cheraw
country: United States
facility: Cheraw Pediatrics Site Number : 8400017
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research Site Number : 8400025
state: South Carolina
city: Dallas
country: United States
facility: Javara Dallas Site Number : 8400135
state: Texas
city: El Paso
country: United States
facility: Pininos Pediatric Services Site Number : 8400121
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials Site Number : 8400015
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Associates Site Number : 8400023
state: Texas
city: Lampasas
country: United States
facility: FMC Science, LLC Site Number : 8400086
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research Site Number : 8400107
state: Texas
city: McAllen
country: United States
facility: Biopharma Informatic Site Number : 8400066
state: Texas
city: San Antonio
country: United States
facility: Benchmark Research San Antonio Site Number : 8400129
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute Site Number : 8400011
state: Texas
city: San Antonio
country: United States
facility: Tekton Research Site Number : 8400076
state: Texas
city: Spokane
country: United States
facility: MultiCare Institute for Research & Innovation Site Number : 8400024
state: Washington
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240002
state: British Columbia
city: Halifax
country: Canada
facility: Investigational Site Number : 1240001
state: Nova Scotia
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240006
state: Ontario
city: Municipio Del Distrito Central
country: Honduras
facility: Investigational Site Number : 3400002
city: San Pedro Sula
country: Honduras
facility: Investigational Site Number : 3400001
city: Bayamón
country: Puerto Rico
facility: Investigational Site Number : 6300002
city: Guayama
country: Puerto Rico
facility: Investigational Site Number : 6300004
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300001
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: