Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influenza vaccine · 1 trial · 1 indication
Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Systemic events including fever, fatigue, headache, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An SAE was defined as any untoward medical occurrence that, at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model
HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model.
| Arm | Type | Description |
|---|---|---|
| Coadministration Group | ACTIVE_COMPARATOR | Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later. |
| Separate Administration Group | ACTIVE_COMPARATOR | Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later. |
| Name | Type | Description |
|---|---|---|
| Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) | BIOLOGICAL | Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Saline | OTHER | Normal saline for injection |
| Influenza vaccine | BIOLOGICAL | Seasonal inactivated influenza vaccine (SIIV) |
Inclusion Criteria: * Male or female participants ≥65 years of age at the time of consent * Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease * Adults who have no history of ever ...
Influenza vaccine is an investigational vaccine being studied for the prevention of pneumococcal disease in adults aged 65 years and older. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Influenza vaccine is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.
Influenza vaccine is in Phase 3 clinical development. It is an investigational product and has not been approved for use outside of clinical trials.
Influenza vaccine has been studied in one completed Phase 3 clinical trial, identified as NCT04526574. This trial evaluated the safety and immunogenicity of the vaccine when coadministered with a seasonal inactivated influenza vaccine in adults aged 65 years and older.
Influenza vaccine is also known as 20vPnC, a 20-valent pneumococcal conjugate vaccine. This alternative name is used in clinical trial documentation and scientific literature.