Comparative Study of Immunogenicity and Safety of a 2-Dose Regimen of ProQuad® Manufactured With rHA
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00566527
First received: November 29, 2007
Last updated: April 3, 2009
Last verified: April 2009
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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:
- Healthy subject of either gender of 9 months of age
- Negative clinical history of measles, mumps, rubella, varicella or zoster
- Informed consent form signed by both parents or legal representative
- 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:
- Febrile illness in the previous 3 days
- Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone or in any combination
- Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days
- Tuberculin test done in the previous 2 days
- Severe chronic disease
- Known active tuberculosis
- Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
- Hereditary problems of fructose intolerance
- Prior known sensitivity or allergy to any component of the vaccine
- Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
- Humoral or cellular immunodeficiency,
- Immunosuppressive therapy at high doses during at least 14 days in the previous 30 days
- Family history of congenital or hereditary immunodeficiency
- Receipt of immunoglobulins or blood-derived products in the previous 150 days
- Receipt of an inactivated vaccine in the previous 14 days
- Receipt of a live non-study vaccine in the previous 28 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566527
Show 47 Study Locations
Show 47 Study LocationsSponsors 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 |
ClinicalTrials.gov processed this record on May 21, 2013