Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pneumococcal Vaccine Polyvalent-Pneumovax 23 · 1 trial · 1 indication
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Titers were expressed in terms of 1/dilution.
The GMs for serotype specific OPA titers were measured using MOPA which was used to evaluate the opsonophagocytic index (50% killing) of pneumococcal anti-capsular polysaccharide antibodies in human serum samples following vaccination. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens.
The GMCs for serotype specific pneumococcal IgG antibodies were measured using ECL, a multiplexed serological assay which allowed for the simultaneous quantification of human IgG against pneumococcal polysaccharide antigens. Ratio was calculated as post-vaccination titer at Day 31 to pre-vaccination titer at Day 1.
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site pain, injection site erythema and injection site swelling.
A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia and shivering.
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. AESI included analyphylaxis.
| Arm | Type | Description |
|---|---|---|
| SP0202-IIb | EXPERIMENTAL | One dose at Day 1 |
| SP0202-VI | EXPERIMENTAL | One dose at Day 1 |
| SP0202-VII | EXPERIMENTAL | One dose at Day 1 |
| Prevnar 13 | ACTIVE_COMPARATOR | One dose at Day 1 |
| Pneumovax 23 | ACTIVE_COMPARATOR | One dose at Day 1 |
| Name | Type | Description |
|---|---|---|
| Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
| Pneumococcal Conjugate Vaccine - formulation 2-SP0202-VI | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
| Pneumococcal Conjugate Vaccine - formulation 3-SP0202-VII | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
| Pneumococcal 13 - valent conjugate vaccine-Prevnar 13 | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: intramuscular |
| Pneumococcal Vaccine Polyvalent-Pneumovax 23 | BIOLOGICAL | Pharmaceutical form:Solution for injection Route of administration: intramuscular |
Inclusion criteria : \- Aged 50 to 84 years on the day of inclusion . Exclusion criteria: * Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks a...
Pneumococcal Vaccine Polyvalent-Pneumovax 23 is used for pneumococcal immunization, which helps protect against infections caused by Streptococcus pneumoniae bacteria. It is being studied in adults aged 50 to 84 years. The vaccine is currently in Phase 2 clinical development and is not yet approved for use.
Pneumococcal Vaccine Polyvalent-Pneumovax 23 is being developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy for pneumococcal immunization.
Pneumococcal Vaccine Polyvalent-Pneumovax 23 is currently in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. One Phase 2 trial has been completed, involving 750 participants, to assess its use for pneumococcal immunization in adults aged 50 to 84 years.
Pneumococcal Vaccine Polyvalent-Pneumovax 23 has one completed clinical trial registered under NCT04583618. This Phase 2 study, titled 'Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years,' enrolled 750 participants in the United States. The trial was randomized, double-blind, and active-controlled, and it included healthy volunteers.
Pneumococcal Vaccine Polyvalent-Pneumovax 23 is not FDA approved. It is an investigational vaccine currently in Phase 2 clinical development. The vaccine is being studied for pneumococcal immunization, but it has not yet completed the clinical trials and regulatory review process required for approval.