Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Va… (NCT02124161) | Clinical Trial Compass
CompletedPhase 4
Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
United States882 participantsStarted 2014-09
Plain-language summary
The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
. Male or female adults 50 years of age or older.
. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
. Negative urine pregnancy test for all female subjects who are of child bearing potential.
Exclusion criteria
. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes
Timeframe: 1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC
2
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)
Timeframe: 1 month after Vaccination 1
3
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1
Timeframe: Within 28 to 42 days after Vaccination 1
4
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2
Timeframe: Within 28 to 42 days after Vaccination 2
5
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination
Timeframe: Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2
6
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up