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The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infections and sinusitis.
Meningitis is an infection in which the tissue around the brain and spine is swollen.
Sepsis is a very serious infection in your blood caused by a germ (a bacteria). Sinusitis is when your sinuses (the air-filled spaces inside your nose and head), are infected.
This study is seeking for healthy participants who:
All participants will receive a single study vaccine shot in the upper arm muscle at the study clinic. The study will compare the experiences of people receiving the vaccine with a new ingredient in the vaccine to those without the new ingredient. This will be done by comparing 2 different dose levels of the new ingredient. It will also be compared against people who receive the vaccine without the new ingredient and at different dose levels. This will help the study team establish if the vaccine with a new ingredient is safe and effective.
Participants will take part in this study for about 12 months. During this time participants will have up to 6 clinic visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these visits.
Some participants will need to have blood taken for laboratory tests before they can be judged to be eligible to be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose multivalent pneumococcal conjugate vaccine formulation A | Experimental | Stage 1 - Participants will be randomized to receive a single injection. |
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| Low dose multivalent pneumococcal conjugate vaccine formulation B | Experimental | Stage 2 - Participants will be randomized to receive a single injection. |
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| Low dose of multivalent pneumococcal conjugate vaccine control | Active Comparator | Primary control - Stages 1 and 2 - Participants will be randomized to receive a single injection. |
|
| Standard dose multivalent pneumococcal conjugate vaccine control | Active Comparator | Control - Stages 1 and 2 - Participants will be randomized to receive a single injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose multivalent pneumococcal conjugate vaccine formulation A | Other | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting local reactions within 7 days after vaccination | Local reactions (redness, swelling, pain at the injection site) after vaccination. | 7 days |
| Percentage of participants reporting systemic events within 7 days after vaccination | Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain, and joint pain) after vaccination. | 7 days |
| Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination | Adverse Events occurring within 1 month after vaccination. | 1 month |
| Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination | SAEs occurring within 6 months after vaccination. | 6 months |
| Percentage of participants reporting Serious Adverse Events (SAEs) withing 12 months after vaccination | SAEs occurring within 12 months after vaccination. | 12 months |
| Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) within 6 months after vaccination | NDCMCs occurring within 6 months after vaccination. | 6 months |
| Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) withing 12 months after vaccination | NDCMCs occurring within 12 months after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal opsonophagocytic activity (OPA) titers | OPA geometric mean titers (GMTs) 1 month after vaccination | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States | ||
| Research Centers of America ( Hollywood ) |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Low dose multivalent pneumococcal conjugate vaccine formulation B | Other | Biological |
|
| Low dose of multivalent pneumococcal conjugate vaccine control | Biological | low dose multivalent pneumococcal conjugate vaccine |
|
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| Standard dose multivalent pneumococcal conjugate vaccine control | Biological | multivalent pneumococcal conjugate vaccine |
|
|
| 12 months |
| Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination | MAAEs occurring within 6 months after vaccination. | 6 months |
| Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination | MAAEs occurring within 12 months after vaccination. | 12 months |
| Stage 1 and Stage 2 Only - Percentage of participants with abnormal hematology and chemistry laboratory values 2 weeks after vaccination | Abnormal hematology and chemistry laboratory values occurring 2 weeks after vaccination. | 2 weeks |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Centennial Medical Group | Columbia | Maryland | 21045 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | United States |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | United States |
| Clinical Trials of Texas, LLC dba Flourish Research | San Antonio | Texas | 78229 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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