A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

Study Overview
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Brief Summary
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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: To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines. Secondary Objectives: To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.

Detailed Description
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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.

Official Title
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Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

Conditions
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Dengue Fever, Dengue Hemorrhagic Fever

Intervention / Treatment
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* Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus
* Biological: OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines
* Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines
* Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Toddler in good health based on medical history and medical examination Toddler aged 12 to 15 months on the day of inclusion Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) Participant and parent/delegate able to attend all scheduled visits and comply with all trial procedures Completion of previous vaccination program according to the national immunization schedule, except for measles Exclusion Criteria : Family members from the Investigator or from the staff involved in the trial Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of central nervous system disorder or disease, including seizures History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion Previous vaccination against measles-mumps-rubella, hepatitis A or varicella Previous vaccination against flavivirus diseases Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances Planned participation in another clinical trial during the present trial period Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response Planned receipt of any vaccine in the 4 weeks following the first trial vaccination Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening Temporary exclusions: vaccination postponed until the condition is resolved: Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination visit Any vaccination received in the 4 weeks preceding vaccination

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Dengue Vaccine Group<br>Participants will receive CYD Dengue vaccine as Visits 1 and 2. | Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus<br>* 0.5 mL, Subcutaneous<br>* Other names: CYD Dengue Vaccine;|
| Active Comparator: Group 2: Control Group<br>Participants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2) | Biological: OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines<br>* 0.5 mL, Subcutaneous and 0.5 mL, Intravascular<br>* Other names: AVAXIM® 80U;|
| Experimental: Group 3: Co-administration Group<br>Participants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2. | Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines<br>* 0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous<br>* Other names: TRIMOVAX®;|
| Experimental: Group 4: Sequential Administration Group<br>Participants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2. | Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)<br>* 0.5 mL Subcutaneous and 0.5 mL Subcutaneous<br>* Other names: NaCl 0.9% (Placebo);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | Day 28 after post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Toddlers