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Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dengue; Dengue Hemorrhagic Fever

Intervention: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus (Biological); NaCl 0.9% (Biological); Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed (Biological); Meningococcal A+C vaccine (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

Summary

The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives:

- To describe the immune response to dengue viruses before and after each vaccination

with CYD dengue vaccine.

- To evaluate the safety of each vaccination with CYD dengue vaccine.

Clinical Details

Official title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Information concerning the immunogenicity of CYD dengue vaccine after primary vaccination.

Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events and serious adverse events post-vaccination with CYD dengue vaccine.

Detailed description: Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.

Eligibility

Minimum age: 9 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria :

- Aged 9 to 16 years on the day of inclusion

- Participant in good health, based on medical history and physical examination

- Provision of assent form/informed consent form signed by the participant and by the

parent(s) or another legally acceptable representative

- Participant and parent(s)/legally acceptable representative(s) able to attend all

scheduled visits and to comply with all trial procedures

- For a female participant of child-bearing potential, avoid becoming pregnant (use of

an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination until at least 4 weeks after the last vaccination Exclusion Criteria :

- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia

- For a female participant of child-bearing potential, known pregnancy or positive

urine pregnancy test at Visit 1

- Participation in another clinical trial investigating a vaccine, drug, medical

device, or a medical procedure in the 4 weeks preceding the first trial vaccination

- Breast-feeding woman

- Planned participation in another clinical trial during the present trial period

- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy

such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy

- Known systemic hypersensitivity to any of the components of any of the trial vaccines

or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances

- Chronic illness at a stage that could interfere with trial conduct or completion, in

the opinion of the Investigator

- Current alcohol abuse or drug addiction that may interfere with the participant's

ability to comply with trial procedures

- Receipt of blood or blood-derived products in the preceding 3 months that might

interfere with the assessment of immune response

- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination

- Planned receipt of any vaccine in the 4 weeks following the first trial vaccination

- Participant deprived of freedom by administrative or court order, or in an emergency

setting, or hospitalized without his/her consent

- Febrile illness (temperature ≥ 38. 0 ºC) or moderate or severe acute illness/infection

on the day of vaccination, according to Investigator judgment

- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding

inclusion contraindicating intramuscular vaccination

- Severe diseases with or without fever, convulsions or neurological abnormalities

without treatment or in progression.

Locations and Contacts

Vitória ES, 29040-091, Brazil
Additional Information

Starting date: August 2010
Last updated: September 18, 2014

Page last updated: August 20, 2015

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