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Cancer Vaccine

25-Valent Pneumococcal Vaccine for Pneumonia

Phase 2
Waitlist Available
Research Sponsored by Inventprise Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy adults who are 18 through 49 years old on the day of randomization (Day 1)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and 28 days post-vaccination (day 29)
Awards & highlights

Study Summary

This trial will test a new vaccine to see if it's safe and effective against pneumococcal diseases.

Who is the study for?
Healthy adults aged 18-49 who can follow the study plan and come back for all visits. Women must not be pregnant, agree to pregnancy tests, and use effective birth control until Day 57. People can't join if they've had pneumococcal vaccines before, recent investigational drugs, certain allergies or reactions to vaccines, immune system issues, or are taking strong immune-altering drugs.Check my eligibility
What is being tested?
This Phase 2 trial is testing three different formulations (A, B, C) of Inventprise's IVT PCV-25 vaccine against a current 20-valent pneumococcal vaccine (PCV 20). The goal is to see how safe they are and how well they work at creating an immune response in healthy adults.See study design
What are the potential side effects?
Possible side effects may include pain at the injection site, fatigue, headache, muscle pain, joint pain. There might also be allergic reactions due to any component of the vaccine like PEG. Side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 49 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and 28 days post-vaccination (day 29)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and 28 days post-vaccination (day 29) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Severe adverse events (SAEs)
Solicited local adverse events (AEs)
Solicited systemic AEs
+1 more
Secondary outcome measures
IgG GMC ratio
IgG GMFR ratio
IgG four-fold rise
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group CExperimental Treatment1 Intervention
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1
Group II: Group BExperimental Treatment1 Intervention
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1
Group III: Group AExperimental Treatment1 Intervention
Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1
Group IV: Group DActive Control1 Intervention
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1

Find a Location

Who is running the clinical trial?

Inventprise Inc.Lead Sponsor
1 Previous Clinical Trials
65 Total Patients Enrolled
Canadian Center for VaccinologyOTHER
10 Previous Clinical Trials
5,822 Total Patients Enrolled
Vaccine Evaluation Center, CanadaOTHER
2 Previous Clinical Trials
120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for enrolment in this study restricted to individuals over 65?

"This medical study is open to adult patients aged 18 and below 49 years old."

Answered by AI

Are there any eligibility requirements to join this research study?

"220 individuals are required for this research trial and must have up-to-date pneumococcal vaccinations and be aged 18 to 49."

Answered by AI

Does Group A pose any risk to public health?

"Our experts at Power have rated Group A's safety level as a 2 due to the lack of data that supports its efficacy, despite evidence supporting its safety."

Answered by AI

Could you inform me if this trial is currently accepting participants?

"According to the information hosted on clinicaltrials.gov, this specific study has concluded its recruitment process and is no longer looking for patients. It was initially posted on October 16th 2023 before being updated lastly on October 10th 2023. Nonetheless, there are still 5 other trials actively recruiting at present."

Answered by AI

What is the geographic breadth of this research endeavor?

"At the current moment, this clinical trial is accepting patients at 4 sites. Of these locations, Halifax, Truro and Saint Louis are prominent cities that have a medical centre offering enrolment. To reduce travel obligations it may be wise to pick the closest site available for you."

Answered by AI

What is the main purpose of this research project?

"Inventprise Inc., the trial's sponsor, reports that their primary outcome measure will be Unsolicited Adverse Effects (AEs) monitored for 7 days post-vaccination. Additionally, IgG Geometric Mean Fold Rise (GMFR), Percentage of Participants with Four-Fold IgG GMC Rise or Greater, and IgG GMC Ratio between IVT PCV-25 and Prevnar 20 Groups are all secondary outcomes being evaluated in this study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
2023. "Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077656.
~0 spots leftby May 2024
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