Pneumococcal DiseasePhase 1NCT05489328

Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

A Phase 1 study testing Candidate-1, Candidate-2 and Candidate-3 in people with Pneumococcal Disease, run by Pfizer at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: Candidate-1, Candidate-2 and Candidate-3
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 394 participants
Where: 18 sitesUnited States
Study dates: 15 Aug 2022to 7 Oct 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female participants ≥18 and ≤49 years of age at the time of consent
Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children

Who cannot join

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
Known or suspected immunodeficiency or other conditions associated with immunosuppression
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

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Centennial Medical Group
Elkridge, Maryland, 21075
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
Clinical Research Consulting
Milford, Connecticut, 06460
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, 55114
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Diagnostics Research Group
San Antonio, Texas, 78229
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
Qps-Mra, Llc
South Miami, Florida, 33143
DM Clinical Research
Tomball, Texas, 77375
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
Orange County Research Center
Tustin, California, 92780
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Accellacare - Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.

Conditions: Pneumococcal Disease
Being tested: Candidate-1, Candidate-2, Candidate-3, Candidate-4, Candidate-5
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Candidate-1Other
Biological
Candidate-2Other
Biological
Candidate-3Other
Biological
Candidate-4Other
Biological
Candidate-5Other
Biological
Candidate-6Other
Biological
Candidate ControlOther
Biological
13vPnCBiological
13-valent pneumococcal conjugate vaccine
PCV15Biological
15-valent pneumococcal conjugate vaccine

Study groups in NCT05489328
Study group	Role	What they receive
Candidate-1	Experimental	Participants to receive a single injection of Candidate-1. Receives: Other: Candidate-1
Candidate-2	Experimental	Participants to receive a single injection of Candidate-2. Receives: Other: Candidate-2
Candidate-3	Experimental	Participants to receive a single injection of Candidate-3. Receives: Other: Candidate-3
Candidate-4	Experimental	Participants to receive a single injection of Candidate-4. Receives: Other: Candidate-4
Candidate-5	Experimental	Participants to receive a single injection of Candidate-5. Receives: Other: Candidate-5
Candidate-6	Experimental	Participants to receive a single injection of Candidate-6. Receives: Other: Candidate-6
Candidate Control	Active comparator	Participants to receive a single injection of Candidate Control. Receives: Other: Candidate Control
13-valent pneumococcal conjugate vaccine (13vPnC)	Other	Participants to receive a single injection of 13vPnC. Receives: Biological: 13vPnC
15-valent pneumococcal conjugate vaccine (PCV15)	Other	Participants to receive a single injection of PCV15. Receives: Biological: PCV15

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
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.
Measured: Within 7 days after study intervention
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
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.
Measured: Within 7 days after study intervention
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
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.
Measured: Within 1 month after study intervention
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
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.
Measured: Within 1 month after study intervention

Secondary outcomes (1)

Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
GMTs and the corresponding 2-sided CIs (from each candidate and candidate control group per the protocol objective) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t distribution).
Measured: 1 month after study intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 20227 Oct 2022

First posted5 Aug 2022
Study start15 Aug 2022
Primary completion7 Oct 2022
Study completion7 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Model description: Parallel Assignment
Masking: None (open label)
Enrolment: 394 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05489328
Sponsor's protocol ID: C4801001
Status last verified: Apr 2024
First submitted: 3 Aug 2022
Last updated: 18 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF PNEUMOCOCCAL CONJUGATE FORMULATIONS IN HEALTHY ADULTS 18 THROUGH 49 YEARS OF AGE
ClinicalTrials.gov ID: NCT05489328
Acronym / sponsor ID: C4801001
Conditions: Pneumococcal Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 394 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Aug 2022 (actual)
Primary completion: 7 Oct 2022 (actual)
Study completion: 7 Oct 2022 (actual)
First posted: 5 Aug 2022 (actual)
Results: Posted 18 Apr 2024

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 the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9
Model description: Parallel Assignment

Arm	Type	Receives
Candidate-1	Experimental	Other: Candidate-1Participants to receive a single injection of Candidate-1.
Candidate-2	Experimental	Other: Candidate-2Participants to receive a single injection of Candidate-2.
Candidate-3	Experimental	Other: Candidate-3Participants to receive a single injection of Candidate-3.
Candidate-4	Experimental	Other: Candidate-4Participants to receive a single injection of Candidate-4.
Candidate-5	Experimental	Other: Candidate-5Participants to receive a single injection of Candidate-5.
Candidate-6	Experimental	Other: Candidate-6Participants to receive a single injection of Candidate-6.
Candidate Control	Active comparator	Other: Candidate ControlParticipants to receive a single injection of Candidate Control.
13-valent pneumococcal conjugate vaccine (13vPnC)	Other	Biological: 13vPnCParticipants to receive a single injection of 13vPnC.
15-valent pneumococcal conjugate vaccine (PCV15)	Other	Biological: PCV15Participants to receive a single injection of PCV15.

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male or female participants ≥18 and ≤49 years of age at the time of consent
Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children

Key exclusion criteria (6 listed)

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
Known or suspected immunodeficiency or other conditions associated with immunosuppression
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation

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
Candidate-1Biological	Other	Candidate-1
Candidate-2Biological	Other	Candidate-2
Candidate-3Biological	Other	Candidate-3
Candidate-4Biological	Other	Candidate-4
Candidate-5Biological	Other	Candidate-5
Candidate-6Biological	Other	Candidate-6
Candidate ControlBiological	Other	Candidate Control
13vPnC13-valent pneumococcal conjugate vaccine	Biological	13-valent pneumococcal conjugate vaccine (13vPnC)
PCV1515-valent pneumococcal conjugate vaccine	Biological	15-valent pneumococcal conjugate vaccine (PCV15)

Primary outcome

Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Time frame: Within 7 days after study intervention
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.
Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Time frame: Within 7 days after study intervention
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.
Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
Time frame: Within 1 month after study intervention
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.
Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
Time frame: Within 1 month after study intervention
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.

1 secondary outcome

Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group
Time frame: 1 month after study intervention

Results and safety

Results posted to the registry on 18 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Candidate-1	41	41
Candidate-2	42	42
Candidate-3	39	38
Candidate-4	43	43
Candidate-5	45	43
Candidate-6	46	46
Candidate - Control	47	46
PCV15	44	41
13vPnC	47	46

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention

Time frame: Within 7 days after study intervention. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Candidate-1 n = 41	Candidate-2 n = 42	Candidate-3 n = 39	Candidate-4 n = 44	Candidate-5 n = 45	Candidate-6 n = 46	Candidate - Control n = 45	PCV15 n = 43	13vPnC n = 46
Redness: Mild	0.0 (0.0 to 8.6)	0.0 (0.0 to 8.4)	0.0 (0.0 to 9.0)	2.3 (0.1 to 12.0)	2.2 (0.1 to 11.8)	4.3 (0.5 to 14.8)	0.0 (0.0 to 7.9)	4.7 (0.6 to 15.8)	0.0 (0.0 to 7.7)
Redness: Moderate	0.0 (0.0 to 8.6)	2.4 (0.1 to 12.6)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.0)	2.2 (0.1 to 11.8)	2.2 (0.1 to 11.5)	0.0 (0.0 to 7.9)	4.7 (0.6 to 15.8)	2.2 (0.1 to 11.5)
Redness: Severe	0.0 (0.0 to 8.6)	0.0 (0.0 to 8.4)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.0)	0.0 (0.0 to 7.9)	0.0 (0.0 to 7.7)	0.0 (0.0 to 7.9)	0.0 (0.0 to 8.2)	0.0 (0.0 to 7.7)
Swelling: Mild	0.0 (0.0 to 8.6)	0.0 (0.0 to 8.4)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.0)	2.2 (0.1 to 11.8)	6.5 (1.4 to 17.9)	0.0 (0.0 to 7.9)	4.7 (0.6 to 15.8)	8.7 (2.4 to 20.8)
Swelling: Moderate	0.0 (0.0 to 8.6)	2.4 (0.1 to 12.6)	0.0 (0.0 to 9.0)	2.3 (0.1 to 12.0)	2.2 (0.1 to 11.8)	0.0 (0.0 to 7.7)	0.0 (0.0 to 7.9)	4.7 (0.6 to 15.8)	0.0 (0.0 to 7.7)
Swelling: Severe	0.0 (0.0 to 8.6)	0.0 (0.0 to 8.4)	2.6 (0.1 to 13.5)	0.0 (0.0 to 8.0)	0.0 (0.0 to 7.9)	2.2 (0.1 to 11.5)	0.0 (0.0 to 7.9)	0.0 (0.0 to 8.2)	0.0 (0.0 to 7.7)
Pain At Injection Site: Mild	12.2 (4.1 to 26.2)	26.2 (13.9 to 42.0)	20.5 (9.3 to 36.5)	25.0 (13.2 to 40.3)	37.8 (23.8 to 53.5)	23.9 (12.6 to 38.8)	11.1 (3.7 to 24.1)	37.2 (23.0 to 53.3)	54.3 (39.0 to 69.1)
Pain At Injection Site: Moderate	0.0 (0.0 to 8.6)	4.8 (0.6 to 16.2)	0.0 (0.0 to 9.0)	2.3 (0.1 to 12.0)	6.7 (1.4 to 18.3)	17.4 (7.8 to 31.4)	2.2 (0.1 to 11.8)	30.2 (17.2 to 46.1)	6.5 (1.4 to 17.9)

Population analysed: Safety population included all participants who received the study intervention.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention

Time frame: Within 7 days after study intervention. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Candidate-1 n = 41	Candidate-2 n = 42	Candidate-3 n = 39	Candidate-4 n = 44	Candidate-5 n = 45	Candidate-6 n = 46	Candidate - Control n = 45	PCV15 n = 43	13vPnC n = 46
Fever: >/=38.0 degrees C to 38.4 degrees C	0.0 (0.0 to 8.6)	0.0 (0.0 to 8.4)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.0)	2.2 (0.1 to 11.8)	4.3 (0.5 to 14.8)	0.0 (0.0 to 7.9)	2.3 (0.1 to 12.3)	2.2 (0.1 to 11.5)
Fever: >38.4 degrees C to 38.9 degrees C	2.4 (0.1 to 12.9)	0.0 (0.0 to 8.4)	2.6 (0.1 to 13.5)	0.0 (0.0 to 8.0)	4.4 (0.5 to 15.1)	0.0 (0.0 to 7.7)	0.0 (0.0 to 7.9)	0.0 (0.0 to 8.2)	4.3 (0.5 to 14.8)
Fever: >38.9 degrees C to 40.0 degrees C	0.0 (0.0 to 8.6)	2.4 (0.1 to 12.6)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.0)	0.0 (0.0 to 7.9)	0.0 (0.0 to 7.7)	0.0 (0.0 to 7.9)	0.0 (0.0 to 8.2)	0.0 (0.0 to 7.7)
Fever: >40.0 degrees C	0.0 (0.0 to 8.6)	0.0 (0.0 to 8.4)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.0)	0.0 (0.0 to 7.9)	0.0 (0.0 to 7.7)	0.0 (0.0 to 7.9)	0.0 (0.0 to 8.2)	0.0 (0.0 to 7.7)
Fatigue: Mild	17.1 (7.2 to 32.1)	19.0 (8.6 to 34.1)	20.5 (9.3 to 36.5)	13.6 (5.2 to 27.4)	11.1 (3.7 to 24.1)	21.7 (10.9 to 36.4)	22.2 (11.2 to 37.1)	20.9 (10.0 to 36.0)	21.7 (10.9 to 36.4)
Fatigue: Moderate	14.6 (5.6 to 29.2)	26.2 (13.9 to 42.0)	12.8 (4.3 to 27.4)

Primary outcome: Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention

Time frame: Within 1 month after study intervention. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Candidate-1 n = 41	Candidate-2 n = 42	Candidate-3 n = 39	Candidate-4 n = 44	Candidate-5 n = 45	Candidate-6 n = 46	Candidate - Control n = 45	PCV15 n = 43	13vPnC n = 46
Value	2.4 (0.1 to 12.9)	4.8 (0.6 to 16.2)	5.1 (0.6 to 17.3)	0.0 (0.0 to 8.0)	8.9 (2.5 to 21.2)	4.3 (0.5 to 14.8)	0.0 (0.0 to 7.9)	2.3 (0.1 to 12.3)	2.2 (0.1 to 11.5)

Population analysed: Safety population included all participants who received the study intervention.

Primary outcome: Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention

Time frame: Within 1 month after study intervention. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Candidate-1 n = 41	Candidate-2 n = 42	Candidate-3 n = 39	Candidate-4 n = 44	Candidate-5 n = 45	Candidate-6 n = 46	Candidate - Control n = 45	PCV15 n = 43	13vPnC n = 46
Value	0.0 (0.0 to 8.6)	0.0 (0.0 to 8.4)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.0)	2.2 (0.1 to 11.8)	0.0 (0.0 to 7.7)	0.0 (0.0 to 7.9)	0.0 (0.0 to 8.2)	0.0 (0.0 to 7.7)

Population analysed: Safety population included all participants who received the study intervention.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Local reactions and systemic events (systematic assessment): up to 7 days after study intervention, SAEs (non-systemic assessment) and non-SAEs (systematic assessment): from Day 1 up to 1 month after study intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Candidate-1	0 of 41 (0%)	25 of 41 (61%)	0 of 41
Candidate-2	0 of 42 (0%)	27 of 42 (64.3%)	0 of 42
Candidate-3	0 of 39 (0%)	21 of 39 (53.8%)	0 of 39
Candidate-4	0 of 44 (0%)	28 of 44 (63.6%)	0 of 44
Candidate-5	1 of 45 (2.2%)	30 of 45 (66.7%)	0 of 45
Candidate-6	0 of 46 (0%)	30 of 46 (65.2%)	0 of 46
Candidate - Control	0 of 45 (0%)	22 of 45 (48.9%)	0 of 45
PCV15	0 of 43 (0%)	32 of 43 (74.4%)	0 of 43
13vPnC	0 of 46 (0%)	37 of 46 (80.4%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

18 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 Candidate-1, Candidate-2 and Candidate-3 in people with Pneumococcal Disease, run by Pfizer at 18 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 6 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 With Local Reactions Within 7 Days After Administration of Study Intervention (time frame: Within 7 days after study intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489328.

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 18 Apr 2024.