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GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)
Phase 3 trial testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) in Papillomavirus Infections in 250 participants. Completed in 15 April 2013.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 250 |
| Start date | 21 March 2011 |
| Primary completion | 15 April 2013 |
| Estimated completion | 15 April 2013 |
Merck Sharp & Dohme LLC — full company profile →
Adults 9 to 26, female only, with Papillomavirus Infections. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 147 | |
| Placebo 9 to 12 Years Old | 1 |
Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of \>=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 147 | |
| Placebo 9 to 12 Years Old | 1 |
Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 160 | |
| Placebo 9 to 12 Years Old | 0 |
Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of \>=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 156 | |
| Placebo 9 to 12 Years Old | 0 |
Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 12 Years Old | 54 | |
| Placebo 13 to 15 Years Old | 21 | |
| GARDASIL 16 to 26 Years Old | 88 | |
| Placebo 9 to 12 Years Old | 9 |
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 12 Years Old | 9 | |
| Placebo 13 to 15 Years Old | 6 | |
| GARDASIL 16 to 26 Years Old | 7 | |
| Placebo 9 to 12 Years Old | 5 |
A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 12 Years Old | 0 | |
| Placebo 13 to 15 Years Old | 0 | |
| GARDASIL 16 to 26 Years Old | 1 | |
| Placebo 9 to 12 Years Old | 0 |
Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 602 | 526 – 689 |
| Placebo 9 to 12 Years Old | NA | NA – NA |
Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 626 | 545 – 718 |
| Placebo 9 to 12 Years Old | NA | NA – NA |
Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 3786 | 3360 – 4265 |
| Placebo 9 to 12 Years Old | NA | NA – NA |
Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL.
| Group | Value | 95% CI |
|---|---|---|
| GARDASIL 9 to 26 Years Old | 811 | 708 – 928 |
| Placebo 9 to 12 Years Old | NA | NA – NA |
Time frame: Serious adverse events were assessed up to 19 months from study start. Other adverse events were assessed up to 15 days after each vaccination in study Phase A.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | GARDASIL 9 to 12 Years Old | GARDASIL 13 to 15 Years Old | GARDASIL 16 to 26 Years Old | Placebo 9 to 12 Years Old |
|---|---|---|---|---|---|
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | — | — | — | — |
| Reaction | System | GARDASIL 9 to 12 Years Old | GARDASIL 13 to 15 Years Old | GARDASIL 16 to 26 Years Old | Placebo 9 to 12 Years Old |
|---|---|---|---|---|---|
| Injection site pain | General disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Injection site swelling | General disorders | — | — | — | — |
| Injection site erythema | General disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Dysmenorrhoea | Reproductive system and breast disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Malaria | Infections and infestations | — | — | — | — |
| Eye pain | Eye disorders | — | — | — | — |
| Myopia | Eye disorders | — | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — | — |
| Somnolence | Nervous system disorders | — | — | — | — |
Most-reported serious reactions: Foetal distress syndrome.
Data from ClinicalTrials.gov NCT01245764 adverse events section.
The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa. Data from the current study are needed in order to complement existing extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™ may be administered safely and will induce immune responses in populations from and living in Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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