Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00988143 · ClinicalTrials.gov registry record · Phase 2
A Study of Influenza Virus Vaccines in Children and Adults
A Phase 2 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
- 4
- Study locations
NCT00988143: Completed Phase 2 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00988143 is a Phase 2 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 600 participants, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00988143, a Phase 2 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults. Observational Objectives: * To describe the safety of the 2009-2010 TIV among subjects ≥6 months to \<5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age. * To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to \<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.
Primary Outcome
Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and
Conditions Studied
Interventions
- BIOLOGICAL 2009-2010 Trivalent Influenza Virus Vaccine
- BIOLOGICAL 2008-2009 Trivalent Influenza Virus Vaccine
- BIOLOGICAL Quadrivalent Influenza Virus Vaccine
Study Locations (4)
North Carolina
- - Durham
Ohio
- - Cincinnati
Pennsylvania
- - Jefferson Hills
Virginia
- - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00988143 record still lists
NCT00988143 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 3 interventions - of which 2009-2010 Trivalent Influenza Virus Vaccine is the first listed.
NCT00988143 reports a single indexed study location in North Carolina, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00988143 about?
NCT00988143 is a clinical study titled "A Study of Influenza Virus Vaccines in Children and Adults". The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadri...
What is the current status of trial NCT00988143?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2009-10. Estimated completion is 2010-03.
What conditions does trial NCT00988143 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00988143?
The interventions under investigation include: 2009-2010 Trivalent Influenza Virus Vaccine (BIOLOGICAL), 2008-2009 Trivalent Influenza Virus Vaccine (BIOLOGICAL), Quadrivalent Influenza Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00988143?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00988143 being conducted?
This trial has 4 study locations across North Carolina, Ohio, Pennsylvania, Virginia. 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 NCT00988143's enrollment target sits among peer trials
600 44th of 156 higher than 112 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
-
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
RECRUITING · Phase 2
-
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
RECRUITING · Phase 2
-
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
RECRUITING · Phase 2
-
Systems Investigation of Vaccine Responses in Aging and Frailty
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004317 · 600 participants · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
- NCT00209235 · 600 participants · NA
Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
- NCT01473784 · 600 participants · NA
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
- NCT01866371 · 600 participants
High Resolution Retinal Imaging
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia