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NCT04382326 · ClinicalTrials.gov registry record · Phase 3

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
1,997
Enrollment target

NCT04382326: Completed Phase 3 study, sponsored by Pfizer.

NCT04382326 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,997 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (159% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04382326, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
1,997 participants
Enrollment target

Study Summary

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

Primary Outcome

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Interventions

  • BIOLOGICAL 20-valent pneumococcal conjugate vaccine
  • BIOLOGICAL 13-valent pneumococcal conjugate vaccine

Trial Details

FieldValue
Enrollment Target 1,997 participants
Start Date 2020-05-20
Est. Completion 2022-09-02
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT04382326 record still lists

NCT04382326 is an interventional study that assigns participants to a tested intervention. Its 1,997 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 (159% higher).

The record links to 0 conditions, and to 2 interventions - of which 20-valent pneumococcal conjugate vaccine is the first listed.

NCT04382326 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04382326 about?

NCT04382326 is a clinical study titled "20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants". 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

What is the current status of trial NCT04382326?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,997 participants. The study started on 2020-05-20. Estimated completion is 2022-09-02.

What interventions are being tested in trial NCT04382326?

The interventions under investigation include: 20-valent pneumococcal conjugate vaccine (BIOLOGICAL), 13-valent pneumococcal conjugate vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT04382326?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04382326's enrollment target sits among peer trials

1,997 106th of 2000 higher than 1,895 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

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Source: ClinicalTrials.gov NCT04382326, the US trial registry maintained by the National Library of Medicine. NCT04382326 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.