Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Pneumococcal Immunisation, Diphtheria Immunisation, Tetanus Immunisation
About this trial
This is an interventional prevention trial for Pneumococcal Immunisation
Eligibility Criteria
Inclusion 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:
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.
Sites / Locations
- The Children's Clinic Of Jonesboro PA-Site Number:8400143
- Southland Clinical Research Center-Site Number:8400040
- Join Clinical Trials Huntington Park-Site Number:8400030
- Matrix Clinical Research Huntington Park-Site Number:8400058
- Matrix Clinical Research-Site Number:8400059
- Orange County Research Institute-Site Number:8400060
- California Research Foundation-Site Number:8400052
- Meridian Clinical Research Washington DC-Site Number:8400119
- International Research Partners, LLC-Site Number:8400077
- Homestead Medical Clinic, P.A.-Site Number:8400032
- Dade Research Center-Site Number:8400122
- Miami Clinical Research-Site Number:8400020
- Amber Clinical Research, LLC-Site Number:8400019
- Jedidiah Clinical Research-Site Number:8400049
- Javara Albany-Site Number:8400140
- Centricity Research Talbotton - DBA IACT Health Research at Talbotton-Site Number:8400062
- Javara Fayetteville-Site Number:8400139
- Dumog Research-Site Number:8400134
- Bingham Memorial Hospital-Site Number:8400067
- Leavitt Clinical Research-Site Number:8400127
- Hutchinson Clinic-Site Number:8400074
- Qualmedica Research, LLC-Site Number:8400084
- Michael W. Simon, MD, PSC-Site Number:8400002
- Meridian Clinical Research, LLC-Site Number:8400112
- Benchmark Research-Site Number:8400012
- MedPharmics, LLC-Site Number:8400132
- Javara Annapolis-Site Number:8400137
- Javara Chevy Chase-Site Number:8400138
- Children's Mercy Hospital-Site Number:8400008
- Boeson Research-Site Number:8400004
- Meridian Clinical Research-Site Number:8400102
- Lincoln Pediatric Group-Site Number:8400125
- Pediatric Infectious Diseases Research-Site Number:8400104
- Atrium Health-Site Number:8400124
- Ardmore Medical Research-Site Number:8400043
- Pediatric Associates of Mt. Carmel-Site Number:8400005
- Cheraw Pediatrics-Site Number:8400017
- Tribe Clinical Research-Site Number:8400025
- Javara Dallas-Site Number:8400135
- Pininos Pediatric Services-Site Number:8400121
- North Texas Clinical Trials-Site Number:8400015
- Houston Clinical Research Associates-Site Number:8400023
- FMC Science, LLC-Site Number:8400086
- DCOL Center for Clinical Research-Site Number:8400107
- Biopharma Informatic-Site Number:8400066
- Benchmark Research San Antonio-Site Number:8400129
- Sun Research Institute-Site Number:8400011
- Tekton Research-Site Number:8400076
- MultiCare Institute for Research & Innovation-Site Number:8400024
- Investigational Site Number :1240002
- Investigational Site Number :1240001
- Investigational Site Number :1240006
- Investigational Site Number :3400002
- Investigational Site Number :3400001
- Investigational Site Number :6300002
- Investigational Site Number :6300004
- Investigational Site Number :6300001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Active Comparator
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Group 7
Group 8
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
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
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
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
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
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
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
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