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Trial record 1 of 1 for:    NCT04398706
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Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

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ClinicalTrials.gov Identifier: NCT04398706
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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])

Condition or disease Intervention/treatment Phase
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 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 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The study will be performed in a modified double-blind fashion:

  • Investigators and study staff who conduct the safety assessment and the participant will not know which vaccine is administered
  • Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation will know which vaccine is administered This study will be observer-blinded between any SP0202 formulation and Prevnar 13 and double-blind across the 3 SP0202 formulations
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : October 13, 2023
Estimated Study Completion Date : October 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
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
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: SP0202-IIb

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®
Experimental: Group 2
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
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: SP0202-VI

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®
Experimental: Group 3
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
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: SP0202-VII

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®
Active Comparator: Group 4
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]
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: Prevnar 13®

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®
Experimental: Group 5
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
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: SP0202-IIb

Biological: Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: Varicella vaccine, VARIVAX®

Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: MMR vaccine, M-M-R ®II

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Other Name: Rotavirus vaccine, RotaTeq

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: Hepatitis B vaccine, ENGERIX-B®
Experimental: Group 6
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
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: SP0202-VI

Biological: Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: Varicella vaccine, VARIVAX®

Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: MMR vaccine, M-M-R ®II

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Other Name: Rotavirus vaccine, RotaTeq

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: Hepatitis B vaccine, ENGERIX-B®
Experimental: Group 7
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
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: SP0202-VII

Biological: Varicella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: Varicella vaccine, VARIVAX®

Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: MMR vaccine, M-M-R ®II

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Other Name: Rotavirus vaccine, RotaTeq

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: Hepatitis B vaccine, ENGERIX-B®
Active Comparator: Group 8
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
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: Varicella vaccine, VARIVAX®

Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form:liquid Route of administration: subcutaneous
Other Name: MMR vaccine, M-M-R ®II

Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: Prevnar 13®

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: DTaP-IPV// Hib vaccine, Pentacel®

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:liquid Route of administration: oral
Other Name: Rotavirus vaccine, RotaTeq

Biological: Hepatitis B Vaccine* [Recombinant] *as applicable
Pharmaceutical form:liquid Route of administration: intramuscular
Other Name: Hepatitis B vaccine, ENGERIX-B®


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants reporting immediate adverse events (AEs) [ Time Frame: Within 30 minutes post-vaccination ]
    Unsolicited (spontaneously reported) systemic AEs after each and any injection of a SP0202 formulation or Prevnar 13

  2. Number of participants reporting solicited injection site and systemic reactions [ Time Frame: Up to Day 7 post-vaccination ]
    Solicited injection site reactions: tenderness, erythema, swelling Solicited systematic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability

  3. Number of participants reporting unsolicited (spontaneously reported) AEs [ Time Frame: Within 30 days after vaccination ]
    Unsolicited AEs (events not solicited) after each and any injection of a SP0202 formulation or Prevnar 13

  4. Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs) [ Time Frame: From Day 0 to Day 480 ]
    SAEs and AESIs are collected throughout the study period

  5. Geometric Mean Concentrations (GMCs) of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers [ Time Frame: Day 30 ]
    Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured

  6. GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in toddlers [ Time Frame: Day 30 ]
    Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post-/pre-vaccination)

  7. Number of infants with serotype-specific IgG concentration above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations [ Time Frame: Day 150 ]
    Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The following threshold values will be considered: ≥ 0.35 µg/mL

  8. GMCs of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants [ Time Frame: Day 330 ]
    Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured

  9. GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants* *as applicable [ Time Frame: Day 150* *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


  10. GMCR of antibodies against all pneumococcal serotypes included in the SP0202 formulations in infants [ Time Frame: Day 330 ]
    Ab concentrations for each pneumococcal serotype included in the SP0202 formulations are measured The calculated ratio is (post- dose 4/pre-dose 4)


Secondary Outcome Measures :
  1. Geometric mean (GM) of serotype specific opsonophagocytic (OPA) titers for all pneumococcal serotypes included in the SP0202 formulations in toddlers [ Time Frame: Day 30 ]
    Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined

  2. Number of toddlers with serotype-specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations [ Time Frame: Day 30 ]
    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)

  3. GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in toddlers [ Time Frame: Day 30 ]
    Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The calculated ratio is (post-/pre-vaccination)

  4. GM of serotype specific OPA titers for all pneumococcal serotypes included in the SP0202 formulations in infants [ Time Frame: Day 150; Day 300; Day 330 ]
    Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined

  5. Number of infants with serotype specific OPA titers above predefined thresholds for each pneumococcal serotype included in the SP0202 formulations [ Time Frame: Day 0; Day 150; Day 300; Day 330 ]
    Serotype specific OPA titers for each pneumococcal serotype included in the SP0202 formulations are determined The following threshold values will be considered: ≥ LLOQ

  6. GM of serotype specific OPA titers ratio for each pneumococcal serotype included in the SP0202 formulations in infants [ Time Frame: Day 300; Day 330 ]
    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)

  7. GM concentrations/titers of antibodies against antigens in DTaP-IPV// Hib vaccine when co- administered with SP0202 or Prevnar 13 in toddlers [ Time Frame: Day 0 ]

    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

  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 [ Time Frame: Day 30 ]

    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

  9. Number of toddlers with concentrations/titers of antibodies above predefined thresholds [ Time Frame: Day 30 ]

    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

  10. GM concentrations/titers of antibodies against antigens in licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants* *as applicable [ Time Frame: Day 0* *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

  11. GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants [ Time Frame: Day 150 ]

    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

  12. Number of infants with concentrations/titers of antibodies above predefined thresholds [ Time Frame: Day 150 ]

    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

  13. GM concentrations/titers of antibodies against antigens in concomitant licensed vaccines when co- administered with SP0202 or Prevnar 13 in infants [ Time Frame: Between Day 330 and Day 420 ]

    The following components are assessed:

    • Anti-measles Ab
    • Anti-mumps Ab
    • Anti-rubella Ab
    • Anti-varicella Ab

  14. Number of participants with concentrations/titers of antibodies above predefined thresholds [ Time Frame: Between Day 330 and Day 420 ]

    The following components are assessed, with predefined thresholds for each:

    • Anti-measles Ab
    • Anti-mumps Ab
    • Anti-rubella Ab
    • Anti-varicella Ab


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   42 Days to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398706


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04398706    
Other Study ID Numbers: PSK00008
U1111-1238-1638 ( Registry Identifier: ICTRP )
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 11, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hepatitis B
Diphtheria
Rubella
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
 Bacterial Infections
Bacterial Infections and Mycoses
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
RNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs