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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Dengue Hemorrhagic Fever; Dengue Fever

Treatments: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines; 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 NaCl (Placebo); Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064141

UTN: U1111-1111-5855 (Other Identifier)

CYD08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 210 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 4 patient groups

Group 1: Dengue Vaccine Group

Experimental group

Description:

Participants will receive CYD Dengue vaccine as Visits 1 and 2.

Treatment:

Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus

Group 2: Control Group

Active Comparator group

Description:

Participants will receive Control Vaccines. (Varicella at Visit 1 and Hepatitis A at Visit 2)

Treatment:

Biological: OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines

Group 3: Co-administration Group

Experimental group

Description:

Participants will receive CYD Dengue vaccine and childhood vaccines at Visit 1 and CYD Dengue vaccine at Visit 2.

Treatment:

Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines

Group 4: Sequential Administration Group

Experimental group

Description:

Participants will receive CYD Dengue vaccine and a Placebo vaccine at Visit 1 and CYD Dengue vaccine at Visit 2.

Treatment:

Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)