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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-5855 | Other Identifier | WHO |
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The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination.
Primary Objectives:
Secondary Objectives:
Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dengue Vaccine Group | Experimental | Participants will receive CYD Dengue vaccine as Visits 1 and 2. |
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| Group 2: Control Group | Active Comparator | Participants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2) |
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| Group 3: Co-administration Group | Experimental | Participants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2. |
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| Group 4: Sequential Administration Group | Experimental | Participants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus | Biological | 0.5 mL, Subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine. | 28 days after each Dengue vaccination and entire study duration |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination. | Day 28 after each Dengue vaccination | |
| To provide information concerning the immunogenicity of childhood vaccines after primary vaccination. |
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Inclusion Criteria :
Exclusion Criteria :
Temporary exclusions: vaccination postponed until the condition is resolved:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Pablo | Philippines |
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| Label | URL |
|---|---|
| Related Info | View source |
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| OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines | Biological | 0.5 mL, Subcutaneous and 0.5 mL, Intravascular |
|
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| Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines | Biological | 0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous |
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| Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo) | Biological | 0.5 mL Subcutaneous and 0.5 mL Subcutaneous |
|
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| Day 28 after post-vaccination |
| ID | Term |
|---|---|
| D003715 | Dengue |
| D019595 | Severe Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
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