Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

Study Overview
=================
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.

Official Title
-----------------
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

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

Intervention / Treatment
-----------------
* Biological: Pneumococcal Conjugate Vaccine formulation 1
* Biological: Pneumococcal Conjugate Vaccine formulation 2
* Biological: Pneumococcal Conjugate Vaccine formulation 3
* 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


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 15 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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 | Biological: Pneumococcal Conjugate Vaccine formulation 1<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: SP0202-IIb;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;|
| Experimental: Group 2<br>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 | Biological: Pneumococcal Conjugate Vaccine formulation 2<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: SP0202-VI;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;|
| Experimental: Group 3<br>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 | Biological: Pneumococcal Conjugate Vaccine formulation 3<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: SP0202-VII;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;|
| Active Comparator: Group 4<br>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 | Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: Prevnar 13®;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;|
| Experimental: Group 5<br>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 | Biological: Pneumococcal Conjugate Vaccine formulation 1<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: SP0202-IIb;Biological: Varicella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: Varicella vaccine, VARIVAX®;Biological: Measles, Mumps, and Rubella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: MMR vaccine, M-M-R ®II;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* Pharmaceutical form:liquid Route of administration: oral<br>* Other names: Rotavirus vaccine, RotaTeq;Biological: Hepatitis B Vaccine* [Recombinant] *as applicable<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: Hepatitis B vaccine, ENGERIX-B®;|
| Experimental: Group 6<br>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 | Biological: Pneumococcal Conjugate Vaccine formulation 2<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: SP0202-VI;Biological: Varicella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: Varicella vaccine, VARIVAX®;Biological: Measles, Mumps, and Rubella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: MMR vaccine, M-M-R ®II;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* Pharmaceutical form:liquid Route of administration: oral<br>* Other names: Rotavirus vaccine, RotaTeq;Biological: Hepatitis B Vaccine* [Recombinant] *as applicable<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: Hepatitis B vaccine, ENGERIX-B®;|
| Experimental: Group 7<br>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 | Biological: Pneumococcal Conjugate Vaccine formulation 3<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: SP0202-VII;Biological: Varicella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: Varicella vaccine, VARIVAX®;Biological: Measles, Mumps, and Rubella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: MMR vaccine, M-M-R ®II;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* Pharmaceutical form:liquid Route of administration: oral<br>* Other names: Rotavirus vaccine, RotaTeq;Biological: Hepatitis B Vaccine* [Recombinant] *as applicable<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: Hepatitis B vaccine, ENGERIX-B®;|
| Active Comparator: Group 8<br>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 | Biological: Varicella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: Varicella vaccine, VARIVAX®;Biological: Measles, Mumps, and Rubella Virus Vaccine Live<br>* Pharmaceutical form:liquid Route of administration: subcutaneous<br>* Other names: MMR vaccine, M-M-R ®II;Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: Prevnar 13®;Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: DTaP-IPV// Hib vaccine, Pentacel®;Biological: Rotavirus Vaccine, Live, Oral, Pentavalent<br>* Pharmaceutical form:liquid Route of administration: oral<br>* Other names: Rotavirus vaccine, RotaTeq;Biological: Hepatitis B Vaccine* [Recombinant] *as applicable<br>* Pharmaceutical form:liquid Route of administration: intramuscular<br>* Other names: Hepatitis B vaccine, ENGERIX-B®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting immediate adverse events (AEs) | Unsolicited (spontaneously reported) systemic AEs after each and any injection of a SP0202 formulation or Prevnar 13 | Within 30 minutes post-vaccination | 
| Number of participants reporting solicited injection site and systemic reactions | Solicited injection site reactions: tenderness, erythema, swelling Solicited systematic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability | Up to Day 7 post-vaccination | 
| Number of participants reporting unsolicited (spontaneously reported) AEs | Unsolicited AEs (events not solicited) after each and any injection of a SP0202 formulation or Prevnar 13 | Within 30 days after vaccination | 
| Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs) | SAEs and AESIs are collected throughout the study period | From Day 0 to Day 480 | 
| Geometric Mean Concentrations (GMCs) of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers | Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured | Day 30 | 
| GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers | Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post-/pre-vaccination) | Day 30 | 
| Number of infants with serotype-specific IgG concentration above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations | Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The following threshold values will be considered: ≥ 0.35 µg/mL | Day 150 | 
| GMCs of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants | Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured | Day 330 | 
| GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants* *as applicable | Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post- dose 3/pre-dose 1)* *as applicable | Day 150* *as applicable | 
| GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants | Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post- dose 4/pre-dose 4) | Day 330 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean (GM) of serotype specific opsonophagocytic (OPA) titers for all pneumococcal serotypes included in the SP0202 formulations in toddlers | Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined | Day 30 | 
| Number of toddlers with serotype-specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations | Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The following threshold values will be considered: ≥ lower limit of quantitation (LLOQ) | Day 30 | 
| GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in toddlers | Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The calculated ratio is (post-/pre-vaccination) | Day 30 | 
| GM of serotype specific OPA titers for all pneumococcal serotypes included in the SP0202 formulations in infants | Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined | Day 150; Day 300; Day 330 | 
| Number of infants with serotype specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations | Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The following threshold values will be considered: ≥ LLOQ | Day 0; Day 150; Day 300; Day 330 | 
| GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in infants | Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The calculated ratio is (post- dose 4/pre-dose 4) | Day 300; Day 330 | 
| GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when co- administered with SP0202 or Prevnar 13 in toddlers | The following components are assessed : Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-PRP Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab Anti-poliovirus (types 1, 2, and 3) Ab | Day 0 | 
| GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when DTaP - IPV// Hib vaccine is co- administered with SP0202 or Prevnar 13 in toddlers | The following components are assessed: Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab and vaccine response Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab | Day 30 | 
| Number of toddlers with concentrations/titers of antibodies above predefined thresholds | The following components are assessed, with predefined thresholds for each: Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab | Day 30 | 
| GM concentrations/titers of antibodies against antigens in licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants* *as applicable | The following components are assessed*: Anti-rotavirus serum immunoglobulin (Ig) A Ab Anti-pertussis (PT, FHA, PRN, and FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab *as applicable | Day 0* *as applicable | 
| GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants | The following components are assessed: IgG Abs against hepatitis B surface antigen Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-rotavirus serum IgA Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab | Day 150 | 
| Number of infants with concentrations/titers of antibodies above predefined thresholds | The following components are assessed, with predefined thresholds for each: IgG Abs against hepatitis B surface antigen Anti-PRP Ab Anti-poliovirus (types 1, 2, 3) Ab Anti-rotavirus serum IgA Ab Anti-pertussis (PT, FHA, PRN, FIM) Ab Anti-diphtheria toxoid Ab Anti-tetanus toxoid Ab | Day 150 | 
| GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants | The following components are assessed: Anti-measles Ab Anti-mumps Ab Anti-rubella Ab Anti-varicella Ab | Between Day 330 and Day 420 | 
| Number of participants with concentrations/titers of antibodies above predefined thresholds | The following components are assessed, with predefined thresholds for each: Anti-measles Ab Anti-mumps Ab Anti-rubella Ab Anti-varicella Ab | Between Day 330 and Day 420 |