NCT00313950

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 13 Months
• Healthy volunteers: Accepted

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.

Conditions

• Measles
• Mumps
• Rubella
• Hepatitis A

Interventions

Type	Name	Description
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)
BIOLOGICAL	Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine	0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)
BIOLOGICAL	Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella	0.5 mL, IM (HAV Day 0 and 168); 0.5 mL, IM (MMR, Day 0)

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-12-01
• Completion: 2010-04-01
• First posted: 2006-04-12
• Last updated: 2014-01-22

Locations

1 site across 1 country: Turkey (Türkiye)