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 2From 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
|