Pneumococcal DiseasePhase 1NCT05831124
A Study to Learn About a Type of Pneumococcal Vaccine With a New Ingredient (PF-07872411) Intended to Enhance the Effects of the Vaccine Which is Given to Adults
A Phase 1 study testing Low dose multivalent pneumococcal conjugate vaccine formulation A and Low dose multivalent pneumococcal conjugate vaccine formulation B in people with Pneumococcal Disease, run by Pfizer at 9 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- Low dose multivalent pneumococcal conjugate vaccine formulation A and Low dose multivalent pneumococcal conjugate vaccine formulation B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Apr 2023to 26 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants ≥50 and ≤64 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 those with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease, within 6 months before receipt of study intervention.
- Female participants of childbearing potential or male participants able to father children and who are willing to use acceptable methods of contraception for at least 28 days after the last dose of study intervention; or female participants not of childbearing potential; or male participants not able to father children.
Who cannot join
- History of a severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine.
- Serious chronic disorder, including history of metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder, that in the investigator's opinion, would make the participant inappropriate for entry into the study.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration.
- Pregnant female participants or breastfeeding female participants (known or suspected).
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
- Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention.
- Receipt of an adjuvanted vaccine containing QS-21 (or similar saponin adjuvant), MPL, or MF59 within 1 year before administration of study intervention
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Centennial Medical Group
Columbia, Maryland, 21045
Centennial Medical Group
Elkridge, Maryland, 21075
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Research Centers of America
Hollywood, Florida, 33024
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Rochester Clinical Research, LLC
Rochester, New York, 14609
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND STUDY OF THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE WITH AN ADJUVANT ADMINISTERED IN ADULTS 50 THROUGH 64 YEARS OF AGE
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.
Read more
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:
- are above 50 years of age and less than 64 years of age.
- have not taken any vaccine for pneumococcal diseases before.
- have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine.
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.
- Conditions
- Pneumococcal Disease
- Being tested
- Low dose multivalent pneumococcal conjugate vaccine formulation A, Low dose multivalent pneumococcal conjugate vaccine formulation B, Low dose of multivalent pneumococcal conjugate vaccine control, Standard dose multivalent pneumococcal conjugate vaccine control
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose multivalent pneumococcal conjugate vaccine formulation AOther
Biological
Low dose multivalent pneumococcal conjugate vaccine formulation BOther
Biological
Low dose of multivalent pneumococcal conjugate vaccine controlBiological
Also called Primary control
low dose multivalent pneumococcal conjugate vaccine
Standard dose multivalent pneumococcal conjugate vaccine controlBiological
Also called Control
multivalent pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| Low dose multivalent pneumococcal conjugate vaccine formulation A | Experimental | Stage 1 - Participants will be randomized to receive a single injection. Receives: Other: Low dose multivalent pneumococcal conjugate vaccine formulation A |
| Low dose multivalent pneumococcal conjugate vaccine formulation B | Experimental | Stage 2 - Participants will be randomized to receive a single injection. Receives: Other: Low dose multivalent pneumococcal conjugate vaccine formulation B |
| 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. Receives: Biological: Low dose of multivalent pneumococcal conjugate vaccine control |
| Standard dose multivalent pneumococcal conjugate vaccine control | Active comparator | Control - Stages 1 and 2 - Participants will be randomized to receive a single injection. Receives: Biological: Standard dose multivalent pneumococcal conjugate vaccine control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions within 7 days after vaccination
Local reactions (redness, swelling, pain at the injection site) after vaccination.
Measured: 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.
Measured: 7 days
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Adverse Events occurring within 1 month after vaccination.
Measured: 1 month
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
SAEs occurring within 6 months after vaccination.
Measured: 6 months
Percentage of participants reporting Serious Adverse Events (SAEs) withing 12 months after vaccination
SAEs occurring within 12 months after vaccination.
Measured: 12 months
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) within 6 months after vaccination
NDCMCs occurring within 6 months after vaccination.
Measured: 6 months
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) withing 12 months after vaccination
NDCMCs occurring within 12 months after vaccination.
Measured: 12 months
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination
MAAEs occurring within 6 months after vaccination.
Measured: 6 months
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination
MAAEs occurring within 12 months after vaccination.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (1)
Pneumococcal opsonophagocytic activity (OPA) titers
OPA geometric mean titers (GMTs) 1 month after vaccination
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start19 Apr 2023
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831124
- Sponsor's protocol ID
- C4941001
- Status last verified
- Jul 2024
- First submitted
- 14 Apr 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE-BLIND STUDY OF THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE WITH AN ADJUVANT ADMINISTERED IN ADULTS 50 THROUGH 64 YEARS OF AGE
- ClinicalTrials.gov ID
- NCT05831124
- Acronym / sponsor ID
- C4941001
- Conditions
- Pneumococcal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- are above 50 years of age and less than 64 years of age.
- have not taken any vaccine for pneumococcal diseases before.
- have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose multivalent pneumococcal conjugate vaccine formulation A | Experimental | Other: Low dose multivalent pneumococcal conjugate vaccine formulation AStage 1 - Participants will be randomized to receive a single injection. |
| Low dose multivalent pneumococcal conjugate vaccine formulation B | Experimental | Other: Low dose multivalent pneumococcal conjugate vaccine formulation BStage 2 - Participants will be randomized to receive a single injection. |
| Low dose of multivalent pneumococcal conjugate vaccine control | Active comparator | Biological: Low dose of multivalent pneumococcal conjugate vaccine controlPrimary control - Stages 1 and 2 - Participants will be randomized to receive a single injection. |
| Standard dose multivalent pneumococcal conjugate vaccine control | Active comparator | Biological: Standard dose multivalent pneumococcal conjugate vaccine controlControl - Stages 1 and 2 - Participants will be randomized to receive a single injection. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female participants ≥50 and ≤64 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 those with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease, within 6 months before receipt of study intervention.
- Female participants of childbearing potential or male participants able to father children and who are willing to use acceptable methods of contraception for at least 28 days after the last dose of study intervention; or female participants not of childbearing potential; or male participants not able to father children.
Key exclusion criteria (8 listed)
- History of a severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine.
- Serious chronic disorder, including history of metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder, that in the investigator's opinion, would make the participant inappropriate for entry into the study.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration.
- Pregnant female participants or breastfeeding female participants (known or suspected).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose multivalent pneumococcal conjugate vaccine formulation ABiological | Other | Low dose multivalent pneumococcal conjugate vaccine formulation A |
| Low dose multivalent pneumococcal conjugate vaccine formulation BBiological | Other | Low dose multivalent pneumococcal conjugate vaccine formulation B |
| Low dose of multivalent pneumococcal conjugate vaccine controlAlso: Primary controllow dose multivalent pneumococcal conjugate vaccine | Biological | Low dose of multivalent pneumococcal conjugate vaccine control |
| Standard dose multivalent pneumococcal conjugate vaccine controlAlso: Controlmultivalent pneumococcal conjugate vaccine | Biological | Standard dose multivalent pneumococcal conjugate vaccine control |
Primary outcome
Percentage of participants reporting local reactions within 7 days after vaccination
Time frame: 7 days
Local reactions (redness, swelling, pain at the injection site) after vaccination.
Percentage of participants reporting systemic events within 7 days after vaccination
Time frame: 7 days
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain, and joint pain) after vaccination.
Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination
Time frame: 1 month
Adverse Events occurring within 1 month after vaccination.
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
Time frame: 6 months
SAEs occurring within 6 months after vaccination.
Percentage of participants reporting Serious Adverse Events (SAEs) withing 12 months after vaccination
Time frame: 12 months
SAEs occurring within 12 months after vaccination.
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) within 6 months after vaccination
Time frame: 6 months
NDCMCs occurring within 6 months after vaccination.
Percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) withing 12 months after vaccination
Time frame: 12 months
NDCMCs occurring within 12 months after vaccination.
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 6 months after vaccination
Time frame: 6 months
MAAEs occurring within 6 months after vaccination.
Percentage of participants reporting Medically Attended Adverse Events (MAAEs) within 12 months after vaccination
Time frame: 12 months
MAAEs occurring within 12 months after vaccination.
Stage 1 and Stage 2 Only - Percentage of participants with abnormal hematology and chemistry laboratory values 2 weeks after vaccination
Time frame: 2 weeks
Abnormal hematology and chemistry laboratory values occurring 2 weeks after vaccination.
1 secondary outcome
Pneumococcal opsonophagocytic activity (OPA) titers
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose multivalent pneumococcal conjugate vaccine formulation A and Low dose multivalent pneumococcal conjugate vaccine formulation B in people with Pneumococcal Disease, run by Pfizer at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting local reactions within 7 days after vaccination (time frame: 7 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.