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NCT02593071 · ClinicalTrials.gov registry record · Phase 2

Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.

A Phase 2 study, sponsored by Novavax.

Completed
Registry status
Phase 2
Development phase
1,330
Enrollment target

NCT02593071: Completed Phase 2 study, sponsored by Novavax.

NCT02593071 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 1,330 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (900% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02593071, a Phase 2 study, has completed, sponsored by Novavax.

COMPLETED
Registry status
Phase 2
Development phase
1,330 participants
Enrollment target

Study Summary

This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.

Primary Outcome

Derived/calculated endpoints based on these data will include: * Geometric mean concentration as EU (GMEU) * Geometric mean ratio (GMR) * Seroresponse rate (SRR) * Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)

Interventions

  • BIOLOGICAL RSV-F Vaccine
  • BIOLOGICAL Phosphate Buffer Placebo

Trial Details

FieldValue
Enrollment Target 1,330 participants
Start Date 2015-10
Est. Completion 2016-11
Phase Phase 2
Novavax

31 total trials

What the finished NCT02593071 record still lists

NCT02593071 is an interventional study that assigns participants to a tested intervention. Its 1,330 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (900% higher).

The record links to 0 conditions, and to 2 interventions - of which RSV-F Vaccine is the first listed.

NCT02593071 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02593071 about?

NCT02593071 is a clinical study titled "Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.". This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV seaso...

What is the current status of trial NCT02593071?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,330 participants. The study started on 2015-10. Estimated completion is 2016-11.

What interventions are being tested in trial NCT02593071?

The interventions under investigation include: RSV-F Vaccine (BIOLOGICAL), Phosphate Buffer Placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT02593071?

This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02593071's enrollment target sits among peer trials

1,330 13th of 2000 higher than 1,988 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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Source: ClinicalTrials.gov NCT02593071, the US trial registry maintained by the National Library of Medicine. NCT02593071 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.