Pneumococcal Immunization
Conditions
Interventions
Product Name: Pneumo PCV
Product Code: 515
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Pneumococcal polysaccharide serotype 6A
Other descriptive name: Pneu
Sponsors
Sanofi Pasteur Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Aged 42 to 89 days on the day of inclusion -Participants who are healthy as determined by medical evaluation including medical history and physical examination -Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight = 1.5 kg, and in both cases medically stable as assessed by the investigator Are the trial subjects under 18? yes Number of subjects for this age range: 1630 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - 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 - History of microbiologically confirmed Streptococcus pneumoniae infection or disease - Any contraindication to the routine pediatric vaccines being administered in the study - History of seizure or significant stable or progressive neurological disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy - Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances - Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), contraindicating intramuscular (IM) injection - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion - Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature = 38.0°C [= 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. - Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for US licensed 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, as applicable per local recommendations. - Previous vaccination against S. pneumoniae - Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and poliovirus - Receipt of more than 1 dose of hepatitis B vaccine - Receipt of immune globulins, blood or blood-derived products since birth - Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of the antibody (Ab) response (immunoglobulin type G [IgG]) induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days after the 3rd dose (Post-dose [PD] 3), as assessed by the seroresponse rate • To demonstrate the non-inferiority of the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days PD3, as assessed by the geometric mean concentration (GMC) • To demonstrate the non-inferiority of the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days after the 4th dose (PD4), as assessed by the GMC;Secondary Objective: To demonstrate the non-inferiority of the immune response of the routine pediatric vaccines administered concomitantly with PCV21 versus 20vPCV at 30 days PD3 • To demonstrate the non-inferiority of the immune response of the routine pediatric vaccines administered concomitantly with PCV21 versus 20vPCV at 30 days PD4 • To demonstrate the superiority of the Ab response (IgG) induced by PCV21 versus 20vPCV for the additional serotype 9N and the serotype 3 at 30 days PD3, as assessed by the seroresponse rate • To demonstrate the superiority of the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for the serotype 9N and the serotype 3 at 30 days PD3, as assessed by the GMC • To demonstrate the superiority of the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for the additional serotype 9N and the serotype 3 at 30 days PD4, as assessed by the GMC To characterize the safety profile of PCV21 after each and any dose ;Primary end point(s): 1. Serotype specific IgG concentration = 0.35 µg/mL 2. Serotype specific IgG Geometric Mean Concentration (GMC) 3. Serotype specific IgG GMC post-dose 4 ;Timepoint(s) of evaluation of this end point: 1 and 2 : 30 days post-dose 3 3 : 30 days post-dose 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. % Antibody concentrations = 10 milli international units per milliliter (mIU/mL) 2. % Antibody concentrations = 0.15 micrograms per milliliter (µg/mL) 3. % Antibody titers = 1:8 4. % Antibody concentrations = 0.1 IU/mL 5. % Antibody concentrations = 0.1 IU/mL 6. Antibody GMC 7. Antibody GMC 8. % Antibody concentrations = 225 milli international units per milliliter (mIU/mL) 9. Antibody GMC 10. % Anti-mumps Ab concentrations = 10 Ab units (AbU)/mL 11. Antibody GMC 12. % Anti-rubella Ab concentrations = 10 IU/mL 13. Antibody GMC 14. Anti-varicella Ab concentrations = 5 glycoprotein enzyme linked immunosorbent assay (gpELISA) units/mL 15. Serotype 9N specific IgG concentration = 0.35 µg/mL 16. Serotype 3 specific IgG concentration = 0.35 µg/mL 17. Serotype 9N specific IgG GMC 18. Serotype 3 specific IgG GMC 19. Serotype 9N specific IgG GMC post-dose 4 20. Serotype 3 specific IgG GMC post-dose 4 21. Serotype specific IgG concentration = 0.35 µg/mL 22. Serotype specific IgG GMC prior to and post-dose 4 23. Antibody GMC 24. Antibody GMC 25. Antibody GMC prior to and post-dose 4 26. Antibody GMC prior to and post-dose 4 27. Number of participants experiencing solicited and unsolicited immediate AEs 28. Number of participants experiencing solicited injection site and systemic reactions 29. Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs 30. Number of participants experiencing SAEs 31. Number of participants experiencing AESIs ;Timepoint(s) of evaluation of this end point: 1 to 7 : 30 days post-dose 3 8 to 14 : 30 days post-dose 4 15 to 18 : 30 days post-dose 3 19 to 21 : 30 days post-dose 4 22 : Before dose 4 and 30 days post-dose 4 23 and 24 : 30 days post-dose 3 25 and 26 : Before dose 4 and 30 days post-dose 4 27 : Within 30 minutes after each vaccine injection 28 : Through 7 days after each vaccine injection 29 : Through 30 days after each va | — |
Countries
Australia, Honduras, Korea, Republic of, Thailand, United States
Contacts
Public ContactClinical Sciences and Operations
Sanofi Pasteur Inc.
Outcome results
None listed