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NCT01654263 · ClinicalTrials.gov registry record · Phase 2
A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 884
- Enrollment target
NCT01654263 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 884 participants.
The verdict
NCT01654263, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 884 participants
- Enrollment target
Study Summary
The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two groups of participants (55 through 74 years of age). First group vaccine naïve participants will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or Group IIB). Blood samples will be obtained at baseline, at one month and six months post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study
Interventions
- BIOLOGICAL Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 884 participants |
| Start Date | 2012-10-10 |
| Est. Completion | 2015-08-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01654263
The ClinicalTrials.gov registry entry for NCT01654263 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 884 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] is the first listed.
NCT01654263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01654263 about?
NCT01654263 is a clinical study titled "A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine". The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two groups of participants (55 through 74 years of age). First group vaccine naïve participants will be open-label to ...
What is the current status of trial NCT01654263?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 884 participants. The study started on 2012-10-10. Estimated completion is 2015-08-21.
What interventions are being tested in trial NCT01654263?
The interventions under investigation include: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (BIOLOGICAL).
Who is sponsoring clinical trial NCT01654263?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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