DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Comparative Study of Immunogenicity and Safety of a 2-Dose Regimen of ProQuad® Manufactured With rHA

Information source: Sanofi Pasteur MSD
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Measles; Mumps; Rubella; Varicella

Intervention: ProQuad® manufactured with recombinant Human Albumine (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi Pasteur MSD

Official(s) and/or principal investigator(s):
Anne FIQUET, MD, Study Director, Affiliation: SPMSD

Summary

- Primary objectives:

- To demonstrate that a 2-dose regimen of ProQuad rHA administered at a 3-month

interval to healthy children of 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.

- To demonstrate that a 2-dose regimen of ProQuad rHA administered at a 3-month

interval to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.

- To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month

interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well-tolerated compared to children of 12 months of age at the time of Dose 1.

- Secondary objectives

- To describe the antibody titres to measles, mumps, rubella and varicella at Day 42

following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.

- To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered

to healthy children from 9 months of age.

Clinical Details

Official title: An Open-Label, Randomised, Comparative, Multi-Centre Study of the Immunogenicity and Safety of a 2-Dose Regimen of ProQuad Manufactured With rHA Administered to Healthy Children From 9 Months of Age

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

antibody response rates to measles, mumps, rubella and varicella measured at Day 42 following Dose 2

From Day 0 to Day 4 following each dose, the rates of subjects with solicited injection-site adverse reactions (injection site erythema; injection site swelling; injection site pain)

Unsolicited injection-site adverse reactions starting from Day 5 to Day 28; Systemic adverse events and rectal (or rectal equivalent) temperature ≥ 39.4°C starting from Day 0 to Day 28

Secondary outcome:

The GMTs to measles, mumps, rubella and varicella; the rate of subjects with varicella antibody titres <1.25 gpELISA units/mL in subjects with baseline varicella antibody titre <1.25 gpELISA units/mL.

antibody response rates for measles, mumps, rubella (MMR) and varicella; GMTs to MMR and varicella; rate of subjects with varicella antibody titres >1.25 gpELISA U/mL in subjects with varicella antibody titre <1.25 gpELISA U/mL.

Intensity, onset, duration and relationship (for systemic adverse events only) of events; Specific description for rashes; Rectal temperature ≥38.0°C

Eligibility

Minimum age: 9 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Healthy subject of either gender of 9 months of age 2. Negative clinical history of measles, mumps, rubella, varicella or zoster 3. Informed consent form signed by both parents or legal representative 4. Parent(s) or legal representative able to attend all the scheduled visits with the subject and to understand and comply with the study procedures Exclusion Criteria: 1. Febrile illness in the previous 3 days 2. Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone or in any combination 3. Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days 4. Tuberculin test done in the previous 2 days 5. Severe chronic disease 6. Known active tuberculosis 7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition 8. Hereditary problems of fructose intolerance 9. Prior known sensitivity or allergy to any component of the vaccine 10. Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems 11. Humoral or cellular immunodeficiency, 12. Immunosuppressive therapy at high doses during at least 14 days in the previous 30 days 13. Family history of congenital or hereditary immunodeficiency 14. Receipt of immunoglobulins or blood-derived products in the previous 150 days 15. Receipt of an inactivated vaccine in the previous 14 days 16. Receipt of a live non-study vaccine in the previous 28 days

Locations and Contacts

Espoo, Finland

Helsinki, Finland

Järvenpää, Finland

Kokkola, Finland

Kotka, Finland

Kuopio, Finland

Lahti, Finland

Oulu, Finland

Pori, Finland

Seinäjoki, Finland

Tampere, Finland

Turku, Finland

Vantaa, Finland

Ancenis, France

Besançon, France

Boulogne Billancourt, France

Chateauroux, France

Clamart, France

Ecully, France

Essey-les-Nancy, France

Lambersart, France

Le Havre, France

Les Sables d'Olonne, France

Rouen, France

Alsfeld, Germany

Berlin, Germany

Bramsche, Germany

Datteln, Germany

Detmold, Germany

Erfurt, Germany

Espelkamp, Germany

Goch, Germany

Karlsruhe, Germany

Kehl, Germany

Köln, Germany

Marbach, Germany

Mönchengladbach, Germany

München, Germany

Neustadt a.d. Aisch, Germany

Nidderau, Germany

Niedernhausen, Germany

Oppenheim, Germany

Pegnitz, Germany

Schwieberdingen, Germany

Schwäbisch Hall, Germany

Wanzleben, Germany

Welzheim, Germany

Additional Information

Starting date: November 2007
Last updated: April 3, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017