Comparing 20-valent pneumococcal conjugate with PG4 for pneumococcal disease
Official title: A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
- Phase 3
- 2 groups
- Sites in London and Sarnia
- Recruiting
Interventions
- Biological therapy
PG4
Multivalent Pneumococcal Vaccine
- Biological therapy
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Canadian Sites (2)
2 listed, none recruiting
- Not yet recruiting
Milestone Research Inc.
London, Ontario
- Not yet recruiting
Bluewater Clinical Research Group Inc.
Sarnia, Ontario
Eligibility Criteria
See who this study is looking for6 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Infants who are about 2 months of age
- +Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion
- −History of severe adverse reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- −Major known congenital malformation or serious chronic disorder.
- −Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would make the participant inappropriate for entry into this study.
- −Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives 20-valent pneumococcal conjugate vaccine (20vPnC).
Registry label: A: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
Group B receives PG4.
Registry label: B: PG4 (intramuscular)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 42 days to 98 days.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,400 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: Day 7.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of participants reporting local reactions within 7 days after each dose — measured over Day 7.
Percentage of participants reporting systemic events within 7 days after each dose — measured over Day 7.
Percentage of participants reporting adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) from Dose 1 to 1 month after Dose 3 — measured over Dose 1 to 1 month after Dose 3.
Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 — measured over Dose 4 to 1 month after Dose 4.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07573462 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PG4Biological
Multivalent Pneumococcal Vaccine
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About 20-valent pneumococcal conjugate vaccine (20vPnC)Biological
20-valent pneumococcal conjugate vaccine (20vPnC)
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 42 days to 98 days.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 42 days to 98 days.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Day 7.
The study as a whole is currently expected to finish around 2028-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: London, Ontario, Canada; Sarnia, Ontario, Canada; Hawthorne, New York, United States; Valhalla, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are: \- infants who are about 2 months of age About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.
Other Sites (2)
Boston Children's Health Physicians
Hawthorne, New York, United States
Maria Fareri Children's Hospital
Valhalla, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.