Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine

• Conditions: MeaslesMumpsRubellaHepatitis A; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005192-24-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

1) Aged 12-13 months on the day of inclusion
2) Born at full term of pregnancy (>37 weeks) with a birth weight = 2.5 kg
3) Informed consent form signed by the parent(s) or other legal representative
4) Able to attend all scheduled visits and to comply with all trial procedures
5) Subjects having received only one or no injection of vaccine against Measles
6) Subjects anti-HAV seronegative according to the results obtained at the screening visit*
Are the trial subjects under 18? yes
Number of subjects for this age range: 470
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 in the 4 weeks preceding the (first) trial vaccination
2) Planned participation in another clinical trial during the present trial period
3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
4) Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
5) Chronic illness at a stage that could interfere with trial conduct or completion
6) Blood or blood-derived products received in the past 3 months
7) Any vaccination in the 4 weeks preceding the first trial vaccination
8) Vaccination planned in the 4 weeks following any trial vaccination
9) History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)
10) Previous vaccination against hepatitis A with the trial vaccine or another vaccine
11) Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine
12) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
13) History of seizures
14) Febrile illness (axillary temperature =37.4°C]) on the day of inclusion

Study & Design

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