Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers

Condition(s) targeted: Dengue; Dengue Hemorrhagic Fever; Yellow Fever

Intervention: Live, attenuated dengue serotype 1, 2, 3, and 4 virus (Biological); Yellow fever vaccine (Biological); Measles, mumps, and rubella vaccine (Biological); Pneumococcal Conjugated Vaccine (Biological); Hepatitis A Pediatric Vaccine (Biological); Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine (Biological); Live, attenuated dengue serotype 1, 2, 3, and 4 virus (Biological); Yellow Fever Vaccine (Biological); Placebo (NaCl) (Biological); Measles, mumps, and rubella vaccine (Biological); Pneumococcal Conjugated Vaccine (Biological); Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

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

Overall contact:
Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com

The study is designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration.

Primary Objective:

- To demonstrate the non-inferiority of the immune response against Yellow Fever in

flavivirus (FV)-naïve subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to subjects receiving one dose of Stamaril vaccine concomitantly with placebo.

Secondary Objectives:

- To assess the non-inferiority of yellow fever immune response 28 days post-Stamaril

vaccination based on seroconversion rates regardless of the FV status of subjects at baseline.

- To describe the safety of Stamaril vaccine administered concomitantly with the first

dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.

- To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine

administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.

Official title: Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru

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

Primary outcome: Information on the antibody to yellow fever virus post Stamaril vaccination

Secondary outcome:

Information concerning the immunogenicity of CYD dengue vaccine post vaccination

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

Detailed description: All participants will receive a total of 8 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies will be performed in a randomized subset of participants. All participants will be followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.

Minimum age: 12 Months. Maximum age: 13 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Aged 12 to 13 months on the day of inclusion.

- Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2. 5 kg as

reported by the parent/legally acceptable representative.

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

- Subject has completed his/her vaccination schedule according to the official

immunization calendar of Colombia and/or Peru, respectively.

- Informed consent form has been signed and dated by the parent(s) or other legally

acceptable representative (and by 2 independent witnesses if required by local regulations).

- Subject and parent/legally acceptable representative/tutor able to attend all

scheduled visits and to comply with all trial procedures. Exclusion Criteria:

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

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

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

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

- Previous vaccination against yellow fever (YF), hepatitis A, or measles, mumps and

rubella.

- Receipt of blood or blood-derived products in the past 3 months which might interfere

with assessment of the immune response.

- Known or suspected congenital or acquired immunodeficiency; or receipt of

immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 weeks or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

- Personal known seropositivity for human immunodeficiency virus (HIV) as reported by

the parent/legally acceptable representative.

- History of previous maternal vaccination against YF as reported by the parent/legally

acceptable representative.

- Personal history of YF or dengue infection/disease as reported by the parent/legally

acceptable representative.

- Known systemic hypersensitivity to any of the vaccine components of the vaccines that

will be used in the trial, or history of a life-threatening reaction to the vaccines used in the trial or to vaccines containing any of the same substances.

- History of contraindication to receipt of vaccines containing components of Stamaril

(yellow fever vaccine), measles, mumps and rubella vaccine, hepatitis A vaccine, pneumococcal conjugated vaccine or of diphtheria (D) toxoid, tetanus (T) toxoid, pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate (PRP) and polio or other DTP vaccine (e. g., DTwP).

- Thrombocytopenia, as reported by the parent/legally acceptable representative.

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,

contraindicating intramuscular (IM) vaccination.

- History of central nervous system disorder or disease, including seizures.

- Personal history of thymic pathology (e. g., thymoma), and/or thymectomy.

- Chronic illness that, in the opinion of the Investigator, is at a stage where it

might interfere with trial conduct or completion.

- Identified as a child (adopted or natural) of the Investigator or of employees of the

Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.

Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com

Cali, Colombia; Recruiting

Lima, Peru; Recruiting

Starting date: September 2011
Last updated: September 16, 2011