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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (565% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is \>0mm.
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 |
What the finished NCT01654263 record still lists
NCT01654263 is an interventional study that assigns participants to a tested intervention. The registered 884 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (565% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01654263's enrollment target sits among peer trials
884 33rd of 2000 higher than 1,968 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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