Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pneumococcal Conjugate Vaccine- formulation 1-SP0202-IIb · 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 Conjugate Vaccine - formulation 1-SP0202-IIb is an investigational vaccine developed by Sanofi for pneumococcal immunization. It is designed to protect against pneumococcal disease and is being studied in adults aged 50 to 84 years. It is a Phase 2 candidate and has not been approved by the FDA.
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb is being developed for pneumococcal immunization, meaning prevention of disease caused by Streptococcus pneumoniae. Its clinical program has focused on adults aged 50 to 84 years. It is an investigational vaccine and is not approved for use.
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this pneumococcal conjugate vaccine candidate.
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb is in Phase 2 development. It is an investigational vaccine and is not FDA approved. The Phase 2 trial has been completed, and no active trials for this candidate are currently listed.
Pneumococcal Conjugate Vaccine - formulation 1-SP0202-IIb has been studied in one Phase 2 trial, NCT04583618, titled Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years. That trial enrolled 750 participants in the United States, was randomized, double blind, and active controlled, and is completed.