NCT00313950

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

April 11, 2006

Last Update Submit

January 17, 2014

Conditions

MeaslesMumpsRubellaHepatitis A

Keywords

measlesrubellamumpshepatitis A

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines.

    Day 7 - Day 196

Study Arms (3)

Group 1

EXPERIMENTAL
Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella

Group 2

EXPERIMENTAL
Biological: Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine

Group 3

EXPERIMENTAL
Biological: Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella

Interventions

Inactivated Hep A vaccine; Attenuated Measles Mumps RubellaBIOLOGICAL

0.5 mL, intramuscular (IM) (HAV Day 0 and 168); 0.5 mL, IM (MMR Day 28)

Also known as: AVAXIM™, TRIMOVAX™
Group 1
Attenuated Measles Mumps Rubella; Inactivated Hep A vaccineBIOLOGICAL

0.5 mL, IM (MMR, Day 0); 0.5 mL, IM (HAV Day 28 and 168)

Also known as: TRIMOVAX™, AVAXIM™
Group 2

Eligibility Criteria

Age12 Months - 13 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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\*

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Izmir, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

MeaslesMumpsRubellaHepatitis A

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsHepatitis, Viral, HumanEnterovirus InfectionsPicornaviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesMeasles VaccineViral VaccinesMumps VaccineRubella Vaccine

Study Officials

  • Medical Director

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Study Completion

April 1, 2010

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

TU(1)