Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents
Public ClinicalTrials.gov record NCT00645411. 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
A Combined Phase II/III, Observer-Blind, Randomized, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children and Adolescents
Study identification
- NCT ID
- NCT00645411
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Novartis
- Industry
- Enrollment
- 3,604 participants
Conditions and interventions
Conditions
Interventions
- Cell culture-derived influenza subunit vaccine (cTIV) Biological
- Egg derived influenza subunit vaccine (eTIV) Biological
Biological
Eligibility (public fields only)
- Age range
- 3 Years to 17 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
- Sep 30, 2007
- Primary completion
- Jan 31, 2008
- Completion
- Jun 30, 2008
- Last update posted
- Nov 22, 2015
2007 – 2008
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 09 | Fayetteville | Arkansas | 72703 | — |
| Site 10 | Downey | California | 90241 | — |
| Site 02 | Bardstown | Kentucky | 40004 | — |
| Site 14 | Metairie | Louisiana | 70006 | — |
| Site 01 | St Louis | Missouri | 63104 | — |
| Site 11 | Omaha | Nebraska | 68134 | — |
| Site 04 | Edison | New Jersey | 08817 | — |
| Site 05 | Endwell | New York | 13760 | — |
| Site 16 | Fort Worth | Texas | 76135 | — |
| Site 13 | San Angelo | Texas | 76904 | — |
| Site 12 | San Antonio | Texas | 78205 | — |
| Site 08 | Bountiful | Utah | 84010 | — |
| Site 07 | Salt Lake City | Utah | 84109 | — |
| Site 03 | Salt Lake City | Utah | 84121 | — |
| Site 06 | Burke | Virginia | 22105 | — |
| Site 15 | Spokane | Washington | 99202 | — |
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 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00645411, 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 Nov 22, 2015 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00645411 live on ClinicalTrials.gov.