Phase 3
Completed N=600
Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)
Source: ClinicalTrials.gov NCT01304498 ↗Enrolled (actual)
600
Serious AEs
0.5%
Results posted
Aug 2017
Primary outcomePrimary: Geometric Mean Titers (GMTs) to HPV Types 16 and 18 — 6739.5; 6887.4; 1956.6; 1795.6 milli Merck Units/mL — p=<0.001
Summary
Primary objective:
• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.
Secondary objectives:
* To evaluate the tolerability of V503 in 9-15 year-old girls.
* To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) to HPV Types 16 and 18 |
6739.5; 6887.4; 1956.6; 1795.6 | <0.001 sig |
| SECONDARY GMTs to HPV Types 6 and 11 |
1679.4; 1565.9; 1315.6; 1417.3 | — |
| SECONDARY Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18 |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Participants With One or More Adverse Events |
96.0; 93.7 | — |
| SECONDARY Percentage of Participants With One or More Injection-site Adverse Reactions |
91.6; 88.3 | — |
| SECONDARY Percentage of Participants With One or More Systemic Adverse Events |
47.5; 52.0 | — |
| SECONDARY Percentage of Participants With Maximum Oral Temperature ≥37.8°C |
6.7; 3.3 | — |
| SECONDARY Percentage of Participants With One or More Serious Adverse Events |
0.3; 0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Female from 9 to 15 years old.
- Good physical health.
Exclusion Criteria
- Known allergy to any vaccine component.
- History of severe allergic reaction.
- Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Pregnant subject.
- Immunocompromised or immunodeficient subject.
- Splenectomy.
- Receipt of medication / vaccine that may interfere with study assessment.
- Fever
- History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
- Any condition that might interfere with study assessment.
Data sourced from ClinicalTrials.gov (NCT01304498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.