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

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00566527
First received: November 29, 2007
Last updated: April 3, 2009
Last verified: April 2009
  Purpose
  • 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.

Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: ProQuad® manufactured with recombinant Human Albumine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • antibody response rates to measles, mumps, rubella and varicella measured at Day 42 following Dose 2 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: from day 0 to day 4 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: from D0 to Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 42 days post dose 2 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 42 days post dose 1 ] [ Designated as safety issue: No ]
  • Intensity, onset, duration and relationship (for systemic adverse events only) of events; Specific description for rashes; Rectal temperature ≥38.0°C [ Time Frame: Post dose 1 and post dose 2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1260
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose 1 at 9 months of age, Dose 2 at 12 months of age.
Biological: ProQuad® manufactured with recombinant Human Albumine
2-dose regimen of ProQuad® (0.5 mL per dose) given at a 3-month interval
Experimental: 2
Dose 1 at 11 months of age, Dose 2 at 14 months of age.
Biological: ProQuad® manufactured with recombinant Human Albumine
2-dose regimen of ProQuad® (0.5 mL per dose) given at a 3-month interval
Active Comparator: 3
Dose 1 at 12 months of age, Dose 2 at 15 months of age.
Biological: ProQuad® manufactured with recombinant Human Albumine
2-dose regimen of ProQuad® (0.5 mL per dose) given at a 3-month interval

  Eligibility

Ages Eligible for Study:   9 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566527

  Show 47 Study Locations
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00566527     History of Changes
Other Study ID Numbers: MRV02C
Study First Received: November 29, 2007
Last Updated: April 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Rubivirus Infections
Togaviridae Infections
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014