Study of Yellow Fever Vaccine Administered With Sanofi Pasteur's Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru

• Conditions: Prevention of symptomatic dengue disease; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001714-26-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-26
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 792

Inclusion Criteria

1) Aged 12 to 13 months on the day of inclusion.
2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg as reported by the parent/legally acceptable representative.
3) Subject in good health, based on medical history and physical examination.
4) Subject has completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively.
5) 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).
6) Subject and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 792
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
2) Planned participation in another clinical trial during the present trial period.
3) Planned receipt of any vaccine in the 4 weeks following first trial vaccination.
4) Previous vaccination against YF, hepatitis A or measles, mumps and rubella.
5) Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response.
6) 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).
7) Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative.
8) History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative.
9) Personal history of YF or dengue infection/disease as reported by the
parent/legally acceptable representative.
10) 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.
11) 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).
12) Thrombocytopenia, as reported by the parent/legally acceptable representative.
13) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
14) History of central nervous system disorder or disease, including seizures.
15) Personal history of thymic pathology (e.g., thymoma), and/or thymectomy.
16) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
17) 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.
Temporary Contraindications:
A prospective subject must not be included in the study until the following conditions and/or symptoms are resolved:
18) Febrile illness (temperature =38.0°C) or moderate or severe acute
illness/infection (according to Investigator judgment) on the day of vaccination.
19) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified