A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children
Public ClinicalTrials.gov record NCT02207413. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process \[LP\]).
Study identification
- NCT ID
- NCT02207413
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,886 participants
Conditions and interventions
Conditions
Interventions
- Influsplit Tetra™ vaccine produced by investigational process (IP) Biological
- Influsplit Tetra™ vaccine produced by licensed process (LP) Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 17, 2014
- Primary completion
- Apr 17, 2015
- Completion
- Apr 17, 2015
- Last update posted
- Jun 5, 2018
2014 – 2015
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Wichita | Kansas | 67207 | — |
| GSK Investigational Site | Rochester | New York | 14609 | — |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02207413, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 5, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02207413 live on ClinicalTrials.gov.