Clinical trial
Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK)…
NCT00344032 · GlaxoSmithKline, Industry · Completed
Key facts
| NCT number | NCT00344032 |
|---|---|
| Title | Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women |
| Official title | Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV-16/18 VLP/AS04 Vaccine Administered Intramuscularly at 0, 1, 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs |
| Lead sponsor | GlaxoSmithKline, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Infections, Papillomavirus |
| Intervention type | Biological |
| Interventions | Placebo, HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) |
| Enrollment | 354 |
| Start date | Jul 28, 2006 |
| Primary completion | Dec 1, 2007 |
| Completion | Dec 4, 2007 |
| First posted | Jun 26, 2006 |
| Last update posted | Jul 20, 2018 |
| Countries | India |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: