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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01064141
First received: February 5, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.

Condition Intervention Phase
Dengue Fever
Dengue Hemorrhagic Fever
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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the safety in terms of solicited and unsolicited adverse events after primary administration of CYD Dengue vaccine. [ Time Frame: 28 days after each Dengue vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide information concerning the immunogenicity of CYD Dengue vaccine after each dose of primary vaccination. [ Time Frame: Day 28 after each Dengue vaccination ] [ Designated as safety issue: No ]
  • To provide information concerning the immunogenicity of childhood vaccines after primary vaccination. [ Time Frame: Day 28 after post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Dengue Vaccine Group
Participants will receive CYD Dengue vaccine as Visits 1 and 2.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue Vaccine
Active Comparator: Group 2: Control Group
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
0.5 mL, Subcutaneous and 0.5 mL, Intravascular
Other Names:
  • OKAVAX®
  • AVAXIM® 80U
Experimental: Group 3: Co-administration Group
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
0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous
Other Names:
  • CYD Dengue Vaccine
  • TRIMOVAX®
Experimental: Group 4: Sequential Administration Group
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)
0.5 mL Subcutaneous and 0.5 mL Subcutaneous
Other Names:
  • CYD Dengue Vaccine
  • NaCl 0.9% (Placebo)

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064141

Locations
Philippines
San Pablo City, Philippines
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01064141     History of Changes
Other Study ID Numbers: CYD08, UTN: U1111-1111-5855
Study First Received: February 5, 2010
Last Updated: February 5, 2013
Health Authority: Philippines: Department of Health

Keywords provided by Sanofi:
Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Toddlers

Additional relevant MeSH terms:
Dengue
Fever
Severe Dengue
Hemorrhagic Fevers, Viral
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014