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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Polio Immunisation; Varicella Immunisation; Measles Immunisation; Pneumococcal Immunisation; Hepatitis B Immunisation; Mumps Immunisation; Diphtheria Immunisation; Pertussis Immunisation; Tetanus Immunisation; Rubella Immunisation; Haemophilus Influenzae Type b Immunisation

Treatments: Biological: Pneumococcal Conjugate Vaccine formulation 3; Biological: Hepatitis B Vaccine* [Recombinant] *as applicable; 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: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Pneumococcal Conjugate Vaccine formulation 1; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Varicella Virus Vaccine Live; Biological: Pneumococcal Conjugate Vaccine formulation 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04398706

U1111-1238-1638 (Registry Identifier)

PSK00008

Details and patient eligibility

About

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])

Full 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.

Enrollment: 852 patients

Sex: All

Ages: 42 days to 15 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

852 participants in 8 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Biological: Pneumococcal Conjugate Vaccine formulation 1

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Group 2

Experimental group

Description:

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

Treatment:

Biological: Pneumococcal Conjugate Vaccine formulation 2

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Group 3

Experimental group

Description:

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

Treatment:

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Biological: Pneumococcal Conjugate Vaccine formulation 3

Group 4

Active Comparator group

Description:

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

Treatment:

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

Group 5

Experimental group

Description:

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

Treatment:

Biological: Varicella Virus Vaccine Live

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Pneumococcal Conjugate Vaccine formulation 1

Biological: Measles, Mumps, and Rubella Virus Vaccine Live

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable

Group 6

Experimental group

Description:

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

Treatment:

Biological: Pneumococcal Conjugate Vaccine formulation 2

Biological: Varicella Virus Vaccine Live

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Measles, Mumps, and Rubella Virus Vaccine Live

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable

Group 7

Experimental group

Description:

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

Treatment:

Biological: Varicella Virus Vaccine Live

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Measles, Mumps, and Rubella Virus Vaccine Live

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable

Biological: Pneumococcal Conjugate Vaccine formulation 3

Group 8

Active Comparator group

Description:

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

Treatment:

Biological: Varicella Virus Vaccine Live

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Biological: Measles, Mumps, and Rubella Virus Vaccine Live

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)

Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable