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Pneumococcal Conjugate Vaccine

Adult Cohort Group 1 for Pneumococcal Vaccines (IVT PCV-25 Trial)

Phase 1
Waitlist Available
Led By Joanne Langley, MD, MSc, FRCPC
Research Sponsored by Inventprise Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 6 months post last vaccination (day 169)
Awards & highlights

IVT PCV-25 Trial Summary

This trial tests a new vaccine to see if it's safe, tolerable and effective in preventing pneumococcal disease in people of all ages.

IVT PCV-25 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 6 months post last vaccination (day 169)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 6 months post last vaccination (day 169) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adult Safety: clinically significant hematological and biochemical measurements
Adult Safety: newly diagnosed chronic medical conditions
Adult Safety: related serious adverse events
+2 more
Secondary outcome measures
Adult Immunogenicity: GMFR OPA GMTs
Adult Immunogenicity: Geometric Mean Fold Rise (GMFR)
Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC)
+1 more

IVT PCV-25 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adult Cohort Group 1Experimental Treatment1 Intervention
Participants will receive a single 0.5mL dose of IVT PCV-25 administered by intramuscular injection on Day 1
Group II: Adult Cohort Group 2Active Control1 Intervention
Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVT PCV-25
2022
Completed Phase 1
~70

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Inventprise Inc.Lead Sponsor
1 Previous Clinical Trials
220 Total Patients Enrolled
Canadian Center for VaccinologyOTHER
10 Previous Clinical Trials
5,977 Total Patients Enrolled
Vaccine Evaluation Center, CanadaOTHER
2 Previous Clinical Trials
275 Total Patients Enrolled

Frequently Asked Questions

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

What purpose does this clinical experiment seek to accomplish?

"According to the clinical trial sponsor, Inventprise Inc., the primary metric for evaluating safety is Adult Safety: unsolicited adverse events. Further measurements will be taken 6 months after vaccination (Day 448), such as Adult Immunogenicity: GMFR OPA GMTs and Infant Immunogenicity: OPA titers along with Serotype-specific IgG GMCs as an indication of adult immunogenicity."

Answered by AI

Could I possibly join this experiment?

"This medical study has a maximum capacity of 520 participants, who must fit into one of three categories: adults aged 18 to 40 years old; children from 24 months to 59 months; or infants 8 weeks through 11 weeks. Furthermore, applicants cannot be immunocompromised and must adhere to Canadian national COVID-19 vaccination regulations (where applicable). All patients that aren't surgically sterile will also need negative pregnancy tests at screening and prior to the vaccine's administration. Finally, all subjects are required to fully comprehend their obligations as part of this trial and provide voluntary written consent in order for admission."

Answered by AI

Does this research trial offer participation to individuals aged 50 and over?

"For participation in this medical trial, patients must be between 8 Weeks and 40 years old. There are separate research projects for minors below 18 and those over 65."

Answered by AI

Are there opportunities for people to join this medical experiment?

"Affirmative. Documentation on clinicaltrials.gov verifies that this research endeavour, which was initially advertised on September 28th 2022, is currently recruiting participants. Around 520 individuals need to be recruited from 1 site for the study to commence."

Answered by AI

How many participants are taking part in this research project?

"Affirmative, the details posted on clinicaltrials.gov demonstrate that this medical trial is actively enrolling participants. Initially published on September 28th 2022, it was last modified on November 6th 2022 and requires 520 individuals to be recruited from a single site."

Answered by AI
~25 spots leftby May 2025