Overview

Primary Objective:

• 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 Objective:

• 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 DTaP-IPV// Hib vaccine antigens before and 1 month following injection of DTaP-IPV// Hib vaccine
• In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (DTaP-IPV// Hib vaccine, Rotavirus vaccine and hepatitis B vaccine, MMR vaccine, varicella vaccine) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1, at post-doses 3 and 4)

Eligibility

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
• Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit (applicable only to infants from the US)

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
• 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 for toddlers, and Visit 6 for infants), 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
• 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-Barr 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 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 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.