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

Measles Clinical Trial

Official title:

Immunogenicity and Safety of AVAXIM™ 80U-Pediatric Administered Alone or Concomitantly With TRIMOVAX™ in 12-13 Months Old Healthy Hepatitis A Seronegative Turkish Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313950
• Other study ID #: HAF65
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2006
• Last updated: January 17, 2014
• Start date: September 2006
• Est. completion date: April 2010

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences Hepatitis A, Measles, Mumps, and Rubella.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 13 Months

Eligibility

Inclusion Criteria:

• Aged 12-13 months on the day of inclusion

• Born at full term of pregnancy (>37 weeks) with a birth weight = 2.5 kg

• Informed consent form signed by the parent(s) or other legal representative

• Able to attend all scheduled visits and to comply with all trial procedures

• Subjects having received only one or no injection of vaccine against Measles

• Subjects anti-HAV seronegative according to the results obtained at the screening visit*

Exclusion Criteria:

• Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination

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

• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy

• 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

• Chronic illness at a stage that could interfere with trial conduct or completion

• Blood or blood-derived products received in the past 3 months

• Any vaccination in the 4 weeks preceding the first trial vaccination

• Vaccination planned in the 4 weeks following any trial vaccination

• History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)

• Previous vaccination against hepatitis A with the trial vaccine or another vaccine

• Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine

• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

• History of seizures

• Febrile illness (axillary temperature =37.4°C]) on the day of inclusion

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Measles
• Mumps
• Rubella

Intervention

Biological:
• Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)
• Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
• Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella
0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.		Day 7 - Day 196	No

External Links

•   Link
•   Link