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| ID | Type | Description | Link |
|---|---|---|---|
| 9427-L1802/1-21C | Other Identifier | Health Canada |
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Two human papillomavirus vaccines are now commercially available.
No clinical data exist regarding:
The main objective of the first phase of this clinical trial was:
• To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls.
The main objective of the seconde phase of this clinical trial is:
• To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.
Study Design & Duration:
Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups.
Duration of the study:
Participants will be followed for the duration of 10 years post-primary vaccination.
Number of Centres:
One Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil, Immunogenicity, Booster dose. | Active Comparator |
| |
| Cervarix, Immunogenicity, Booster dose. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil vaccine, Immunogenicity, Booster dose. | Biological | Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody to HPV | The effect of a booster dose of Gardasil or Cervarix administered randomly (1:1) to subjects vaccinated 42 months before with two doses of Gardasil. | 1 month post booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil. | Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Gilca, MD, PhD | INSPQ, CHUQ-CHUL, Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University Research Hospital Center | Québec | G1E7G9 | Canada |
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|
| Cervarix Vaccine, Immunogenicity, Booster Dose. | Biological | Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later. |
|
|
| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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