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NCT03621670 · ClinicalTrials.gov registry record · Phase 3

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
1,196
Enrollment target

NCT03621670 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,196 participants.

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The verdict

NCT03621670, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
1,196 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

Interventions

  • BIOLOGICAL Rotarix
  • BIOLOGICAL Pediarix
  • BIOLOGICAL Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
  • BIOLOGICAL Prevnar13
  • BIOLOGICAL Hiberix

Trial Details

FieldValue
Enrollment Target 1,196 participants
Start Date 2018-07-27
Est. Completion 2024-12-27
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT03621670

The ClinicalTrials.gov registry entry for NCT03621670 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Rotarix is the first listed.

NCT03621670 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03621670 about?

NCT03621670 is a clinical study titled "Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants". The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant ...

What is the current status of trial NCT03621670?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,196 participants. The study started on 2018-07-27. Estimated completion is 2024-12-27.

What interventions are being tested in trial NCT03621670?

The interventions under investigation include: Rotarix (BIOLOGICAL), Pediarix (BIOLOGICAL), Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) (BIOLOGICAL), Prevnar13 (BIOLOGICAL), Hiberix (BIOLOGICAL).

Who is sponsoring clinical trial NCT03621670?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.