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NCT02148211 · ClinicalTrials.gov registry record
Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry
A clinical trial of Influenza, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 507
- Enrollment target
- 1
- Study location
NCT02148211: Completed study of Influenza, sponsored by GlaxoSmithKline.
NCT02148211 is a study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 507 participants, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02148211, a study of Influenza, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 507 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent.
Primary Outcome
Exposures and outcomes were stratified by trimester of exposure: first (1st), second (2nd), third (3rd) and unknown trimester (Tr?) multiple exposures during a pregnancy were classified by the earliest trimester of exposure. The estimated gestational age at the time of vaccination was calculated based on the date of the last menstrual period. The 2nd trimester was considered to begin at week 14 and the 3rd trimester begun at week 28. The presence or absence of birth defects or other abnormalitie
Conditions Studied
Interventions
- OTHER Data collection
Study Locations (1)
North Carolina
- GSK Investigational Site - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2014-06-01 |
| Est. Completion | 2019-05-31 |
What the finished NCT02148211 record still lists
NCT02148211 is an observational study that tracks outcomes without assigning an intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Data collection is the first listed.
NCT02148211 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02148211 about?
NCT02148211 is a clinical study titled "Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry". The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval...
What is the current status of trial NCT02148211?
This trial is currently completed. The enrollment target is 507 participants. The study started on 2014-06-01. Estimated completion is 2019-05-31.
What conditions does trial NCT02148211 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT02148211?
The interventions under investigation include: Data collection (OTHER).
Who is sponsoring clinical trial NCT02148211?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02148211 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02148211's enrollment target sits among peer trials
507 51st of 156 higher than 106 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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