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NCT03550313 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 565
- Enrollment target
NCT03550313: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT03550313 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 565 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (325% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03550313, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 565 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).
Primary Outcome
Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gen
Interventions
- BIOLOGICAL Prevnar 13
- BIOLOGICAL Multivalent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 565 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2020-11-05 |
| Phase | Phase 2 |
Why NCT03550313 stopped before completion
NCT03550313 is an interventional study that assigns participants to a tested intervention. The registered 565 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 (325% higher).
The record links to 0 conditions, and to 2 interventions - of which Prevnar 13 is the first listed.
NCT03550313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03550313 about?
NCT03550313 is a clinical study titled "Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants". This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccin...
What is the current status of trial NCT03550313?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 565 participants. The study started on 2018-06-01. Estimated completion is 2020-11-05.
What interventions are being tested in trial NCT03550313?
The interventions under investigation include: Prevnar 13 (BIOLOGICAL), Multivalent (BIOLOGICAL).
Who is sponsoring clinical trial NCT03550313?
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 NCT03550313's enrollment target sits among peer trials
565 60th of 2000 higher than 1,941 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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