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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    840
  • sponsor
    Sanofi
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Updated on 3 February 2023
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Accepts healthy volunteers

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])

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.

Details
Condition 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
Treatment Rotavirus Vaccine, Live, Oral, Pentavalent, Measles, Mumps, and Rubella Virus Vaccine Live, Varicella Virus Vaccine Live, Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein], Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate), Pneumococcal Conjugate Vaccine formulation 1, Pneumococcal Conjugate Vaccine formulation 2, Pneumococcal Conjugate Vaccine formulation 3, Hepatitis B Vaccine* [Recombinant] *as applicable
Clinical Study IdentifierNCT04398706
SponsorSanofi
Last Modified on3 February 2023

Eligibility

 Yes No Not Sure

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
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