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The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls/women aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls/women in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Girls/women and boys vaccinated with single dose CERVAVAC-4 vaccine | Experimental | CERVAVAC-4 single dose vaccine will be administered - off label in one arm |
|
| Girls/women and boys vaccinated with single dose Gardasil-4 vaccine | Active Comparator | Gardasil-4 single dose vaccine will be administered in one arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quadrivalent HPV vaccine | Biological | CERVAVAC-4 single dose vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean Titre (GMT) of IgG antibodies against HPV 16 and 18 assessed from blood samples collected at 24 months and measured by M9ELISA on Meso-scale Discovery (MSD®) platform | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ravivarman LAKSHMANASAMY, Dr | Contact | +33 621507700 | lakshmanasamyr@iarc.who.int |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chipata and Matero First Level Hospitals | Lusaka | Zambia |
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| quadrivalent HPV vaccine | Biological | Gardasil-4 single dose |
|
|
| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
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