Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00521586 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,116
- Enrollment target
NCT00521586: Completed Phase 3 study, sponsored by Pfizer.
NCT00521586 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,116 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00521586, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,116 participants
- Enrollment target
Study Summary
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Primary Outcome
Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen
Interventions
- BIOLOGICAL 13 valent pneumococcal conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,116 participants |
| Start Date | 2007-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT00521586 record still lists
NCT00521586 is an interventional study that assigns participants to a tested intervention. Its 1,116 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 1 intervention - of which 13 valent pneumococcal conjugate vaccine is the first listed.
NCT00521586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00521586 about?
NCT00521586 is a clinical study titled "Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine". This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), ...
What is the current status of trial NCT00521586?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,116 participants. The study started on 2007-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00521586?
The interventions under investigation include: 13 valent pneumococcal conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00521586?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00521586's enrollment target sits among peer trials
1,116 251st of 2000 higher than 1,750 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02140255 · 1,120 participants · Phase 1
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
- NCT06618534 · 1,120 participants · Phase 2
Azithromycin for Meningococcal Carriage
- NCT07164131 · 1,120 participants · Phase 4
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
- NCT05691478 · 1,122 participants · Phase 2
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia