| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10069578 |
| E.1.2 | Term | Pneumococcal immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
- 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) |
|
| E.2.2 | Secondary objectives of the trial |
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)
- 1 month after the administration of 3 doses in a subset of infants (Groups 5-8)
- 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]) |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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 |
|
| E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply:
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 |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1 - Number of participants reporting immediate adverse events (AEs)
2 - Number of participants reporting solicited injection site and systemic reactions
3 - Number of participants reporting unsolicited (spontaneously reported) AEs
4 - Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
5 - Geometric Mean Concentrations (GMCs) of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers
6 - GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers
7 - Number of infants with serotype-specific IgG concentration above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
8 - GMCs of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants
9 - GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants*
*as applicable
10 - GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 - Within 30 minutes post-vaccination
2 - Up to Day 7 post-vaccination
3 - Within 30 days after vaccination
4 - From Day 0 until Day 480
5, 6 - Day 30
7 - Day 150
8, 10 - Day 330
9 - Day 150*
*as applicable |
|
| E.5.2 | Secondary end point(s) |
1 - Geometric mean (GM) of serotype specific opsonophagocytic (OPA) titers for all pneumococcal serotypes included in the SP0202 formulations in toddlers
2 - Number of toddlers with serotype-specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
3 - GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in toddlers
4 - GM of serotype specific OPA titers for all pneumococcal serotypes included in the SP0202 formulations in infants
5 - Number of infants with serotype specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations
6 - GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in infants
7 - GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when co- administered with SP0202 or Prevnar 13 in toddlers
8 - 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
9 - Number of toddlers with concentrations/titers of antibodies above predefined thresholds
10 - GM concentrations/titers of antibodies against antigens in licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants*
*as applicable
11 - GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants
12 - Number of infants with concentrations/titers of antibodies above predefined thresholds
13 - GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants
14 - Number of participants with concentrations/titers of antibodies above predefined thresholds |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2, 3, 8, 9 - Day 30
4 - Day 150; Day 300; Day 330
5 - Day 0, Day 150; Day 300; Day 330
6 - Day 300; Day 330
7 - Day 0
10 - Day 0*
*as applicable
11, 12 - Day 150
13, 14 - Between Day 330 and Day 420 |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
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| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 8 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
| Canada |
| Honduras |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| 6-months follow up safety phone contact: participants’ parents / guardians will be contacted by phone 8 days [+2 days] after each vaccine injection, and 6 months [+14 days] after the last vaccine injection. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 14 |
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