Study of a Booster Injection of Pentaxim™ Vaccine Administered With Sanofi Pasteur's Dengue Vaccine in Healthy Toddlers Aged 15 to 18 Months in Mexico

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

• Registration Number: EUCTR2014-001736-11-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: 732

Inclusion Criteria

1) Aged 9 to 12 months on the day of inclusion.
2) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg.
3) Subject in good health, based on medical history and physical examination.
4) Documentation of completion of the primary vaccination series with Pentaxim vaccine with 3 doses received between 2 and 8 months of age.
5) Informed consent form has been signed and dated by both parents or other legally acceptable representative (and by 2 mandatory witnesses as required by local regulations).
6) Subject and parent/guardian are 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: 732
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 any trial vaccination.
4) Previous vaccination against flavivirus diseases, measles, mumps, rubella, previous booster vaccination against pneumococcal diseases, diphtheria, tetanus, pertussis, Hib and/or polio.
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 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
7) Personal seropositivity for human immunodeficiency virus (HIV) or hepatitis C as reported by the parent(s)/legally acceptable representative.
8) History of pertussis and/or Hib infection as reported by the parent(s)/legally acceptable representative.
9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
10) History of contraindication to the receipt of vaccines containing components of Pentaxim vaccine (diphtheria toxoid, tetanus toxoid, PT, FHA, PRP and polio) or of MMR (measles, mumps and rubella) vaccine or of pneumococcal conjugate vaccine.
11) Thrombocytopenia, as reported by the parent(s)/legally acceptable
representative.
12) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
13) History of central nervous system disorder or disease, including seizures.
14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
15) Identified as a child (adopted or natural) of the Investigator or of site 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 Exclusion Criteria:
A prospective subject must not be included in the study until the following conditions and/or symptoms are resolved:
16) Febrile illness (temperature = 38.0°C) or moderate or severe acute
illness/infection (according to Investigator judgment) on the day of vaccination.
17) 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