Pneumoccocal Immunisation Clinical Trial
Official title:
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years
| Verified date | August 2022 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Primary Objective: - To assess the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination - To assess the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | January 20, 2022 |
| Est. primary completion date | August 9, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 50 Years to 84 Years |
| Eligibility | Inclusion criteria : - Aged 50 to 84 years on the day of inclusion . - Able to attend all scheduled visits and to comply with all trial procedures. Exclusion criteria: - Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. - Participation at the time of the study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure. - Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine from enrollment through the last blood sampling Visit, except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. - Previous vaccination against S. pneumoniae with either a pneumococcal conjugated vaccine (PCV) or a pneumococcal polysaccharide vaccine (PPSV). - 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 S. pneumoniae infection or disease, confirmed either serologically, or microbiologically. - History of Guillain-Barré syndrome occurring within 6 weeks after a prior dose of a TTxd-containing vaccine. - Experienced an Arthus-type hypersensitivity reaction following a prior dose of a TTxd-containing vaccine < 10 years ago. - Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances . - Verbal report of thrombocytopenia contraindicating IM vaccination in the Investigator's opinion. - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion. - At risk of invasive pneumococcal disease (eg, participants with functional or anatomic asplenia, participants with severe asthma, participants travelling to countries with high endemicity). - Current alcohol abuse or drug addiction. - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. - Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine (eg, under investigation or monitoring for possible coronavirus disease 2019 [COVID-19]). - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 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 subsided. - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Investigational Site Number :8400014 | Anaheim | California |
| United States | Investigational Site Number :8400007 | Columbus | Ohio |
| United States | Investigational Site Number :8400011 | Fargo | North Dakota |
| United States | Investigational Site Number :8400016 | Jacksonville | Florida |
| United States | Investigational Site Number :8400013 | Las Vegas | Nevada |
| United States | Investigational Site Number :8400018 | Lincoln | Nebraska |
| United States | Investigational Site Number :8400010 | Medford | Oregon |
| United States | Investigational Site Number :8400003 | Meridian | Idaho |
| United States | Investigational Site Number :8400005 | Metairie | Louisiana |
| United States | Investigational Site Number :8400017 | Miami | Florida |
| United States | Investigational Site Number :8400006 | Newark | New Jersey |
| United States | Investigational Site Number :8400004 | North Charleston | South Carolina |
| United States | Investigational Site Number :8400009 | Pittsburgh | Pennsylvania |
| United States | Investigational Site Number :8400012 | Rolling Hills Estates | California |
| United States | Investigational Site Number :8400008 | Salt Lake City | Utah |
| United States | Investigational Site Number :8400001 | Valparaiso | Indiana |
| United States | Investigational Site Number :8400002 | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Geometric Mean (GM) of serotype specific opsonophagocytic (OPA) titers for all pneumococcal serotypes included in the SP0202 formulations | Serotype specific OPA titers for all pneumococcal serotypes included in the SP0202 formulations are determined | Day 31 | |
| Primary | GM of serotype specific OPA titers ratio for all pneumococcal serotype included in the SP0202 formulations | Serotype specific OPA titers for all pneumococcal serotypes included in the SP0202 formulations are determined The calculated ratio is (post/pre-vaccination) | Day 31 | |
| Primary | Geometric Mean Concentrations (GMCs) of antibodies against all pneumococcal serotypes included in the SP0202 formulations | Ab concentrations for all pneumococcal serotypes included in the SP0202 formulations are measured | Day 31 | |
| Primary | Geometric Mean Concentrations Ratio (GMCR) of antibodies against all pneumococcal serotypes included in the SP0202 formulations | Ab concentrations for all pneumococcal serotypes included in the SP0202 formulations are measured The calculated ratio is (post-/pre-vaccination) | Day 31 | |
| Primary | Number of participants reporting immediate adverse events (AEs) | Unsolicited (spontaneously reported) systemic AEs after vaccination with a SP0202 formulation, Prevnar 13 or Pneumovax 23 | Within 30 minutes post-vaccination | |
| Primary | Number of participants reporting solicited injection site and systemic reactions | Solicited injection site and systemic reactions after vaccination with a SP0202 formulation, Prevnar 13 or Pneumovax 23 Solicited injection site reactions: pain, erythema, swelling Solicited systematic reactions: fever, headache, malaise, myalgia, arthralgia, shivering | Up to Day 8 | |
| Primary | Number of participants reporting unsolicited (spontaneously reported) AEs | Unsolicited AEs (events not solicited) after vaccination with a SP0202 formulation, Prevnar 13 or Pneumovax 23 | Up to Day 31 | |
| Primary | Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs) | SAEs and AESIs are collected throughout the study period | Up to Day 181 |