| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03835975 | Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination | PHASE3 | COMPLETED | 875 | — | — | Feb 12, 2019 | Feb 12, 2020 | Feb 21, 2021 | 42 | United States, Sweden |
| NCT05489328 | Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age | PHASE1 | COMPLETED | 394 | — | — | Aug 15, 2022 | Oct 7, 2022 | Apr 18, 2024 | 18 | United States |
Local reactions were recorded 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).
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized to \>=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).
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
An SAE was any untoward medical occurrence 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 or significant 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.
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.
Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\>) 2.0 cm to 5.0 cm, moderate: \>5.0 cm to 10.0 cm and severe \> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees 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 activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - 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 and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
| Arm | Type | Description |
|---|---|---|
| 13vPnC | ACTIVE_COMPARATOR | Pneumococcal conjugate vaccine |
| PPSV23 | ACTIVE_COMPARATOR | Pneumococcal polysaccharide vaccine |
| 20vPnC | EXPERIMENTAL | Pneumococcal conjugate vaccine |
| Candidate-1 | EXPERIMENTAL | Participants to receive a single injection of Candidate-1. |
| Candidate-2 | EXPERIMENTAL | Participants to receive a single injection of Candidate-2. |
| Candidate-3 | EXPERIMENTAL | Participants to receive a single injection of Candidate-3. |
| Candidate-4 | EXPERIMENTAL | Participants to receive a single injection of Candidate-4. |
| Candidate-5 | EXPERIMENTAL | Participants to receive a single injection of Candidate-5. |
| Candidate-6 | EXPERIMENTAL | Participants to receive a single injection of Candidate-6. |
| Candidate Control | ACTIVE_COMPARATOR | Participants to receive a single injection of Candidate Control. |
| 13-valent pneumococcal conjugate vaccine (13vPnC) | OTHER | Participants to receive a single injection of 13vPnC. |
| 15-valent pneumococcal conjugate vaccine (PCV15) | OTHER | Participants to receive a single injection of PCV15. |
| Name | Type | Description |
|---|---|---|
| 13vPnC | BIOLOGICAL | Pneumococcal conjugate vaccine |
| PPSV23 | BIOLOGICAL | Pneumococcal polysaccharide vaccine |
| 20vPnC | BIOLOGICAL | Pneumococcal conjugate vaccine |
| Candidate-1 | OTHER | Biological |
| Candidate-2 | OTHER | Biological |
| Candidate-3 | OTHER | Biological |
| Candidate-4 | OTHER | Biological |
| Candidate-5 | OTHER | Biological |
| Candidate-6 | OTHER | Biological |
| Candidate Control | OTHER | Biological |
| PCV15 | BIOLOGICAL | 15-valent pneumococcal conjugate vaccine |
Inclusion Criteria 1. Male or female adults 65 years of age or greater. 2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change i...