ProQuad® rHA Safety
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00560755
First received: November 19, 2007
Last updated: April 3, 2009
Last verified: April 2009
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Purpose
Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with rHA when administered to children in their second year of life.
Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life
| Condition | Intervention | Phase |
|---|---|---|
|
Measles Mumps Rubella Varicella |
Biological: ProQuad® manufactured with rHA |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open-Label, Multi-Centre Study of the Safety of a 2-Dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured With Recombinant Human Albumin (rHA) When Administered to Children in Their Second Year of Life |
Resource links provided by NLM:
Further study details as provided by Sanofi Pasteur MSD:
Primary Outcome Measures:
- Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: from day 0 to day 4 following second dose ] [ Designated as safety issue: Yes ]
- Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: Day 0 to Day 28 following second dose ] [ Designated as safety issue: Yes ]
- Serious Adverse Events [ Time Frame: from Day 0 to next visit (or last visit in case of premature discontinuation) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Solicited injection-site adverse reactions (erythema, swelling, pain) [ Time Frame: From Day 0 to Day 4 following first dose ] [ Designated as safety issue: Yes ]
- Unsolicited injection-site adverse reactions, Numeric values of temperature, Systemic Adverse Event [ Time Frame: From Day 0 to Day 28 following first dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 3340 |
| Study Start Date: | October 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: ProQuad® manufactured with rHA
Measles-Mumps-Rubella-Varicella live vaccine
|
Eligibility| Ages Eligible for Study: | 12 Months to 22 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy subject of either gender,
- Age from 12 to 22 months,
- Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
- Informed consent form signed by the parent(s) or by legal representative
- Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures
Exclusion Criteria:
- Recent (≤ 3 days) history of febrile illness
- Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
- Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
- Prior known sensitivity/allergy to any component of the vaccine
- Severe chronic disease,
- Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
- Humoral or cellular immunodeficiency,
- Current immunosuppressive therapy
- Family history of congenital or hereditary immunodeficiency
- Hereditary problems of fructose intolerance
- Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
- Known active tuberculosis
- Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
- Receipt of immunoglobulins or blood-derived products in the past 150 days
- Receipt of an inactivated vaccine in the past 14 days
- Receipt of a live vaccine in the past 28 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560755
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Hide Study LocationsLocations
| Denmark | |
| Hvidovre, Denmark | |
| Germany | |
| Aalen, Germany | |
| Bad Kreuznach, Germany | |
| Bad Oeynhausen, Germany | |
| Bad Säckingen, Germany | |
| Bad Wimpfen, Germany | |
| Bindlach, Germany | |
| Bönnigheim, Germany | |
| Darmstadt, Germany | |
| Eisenberg, Germany | |
| Ellhofen, Germany | |
| Eschborn, Germany | |
| Ettenheim, Germany | |
| Falkensee, Germany | |
| Gütersloh, Germany | |
| Heilbronn, Germany | |
| Herbolzheim, Germany | |
| Jena, Germany | |
| Langenselbold, Germany | |
| Lauffen, Germany | |
| Lörrach, Germany | |
| Mannheim, Germany | |
| Minden, Germany | |
| Neuhaus, Germany | |
| Nürnberg, Germany | |
| Oberhausen, Germany | |
| Schramberg, Germany | |
| Solingen, Germany | |
| Stuttgart, Germany | |
| Traunreut, Germany | |
| Velpke, Germany | |
| Vilsbiburg, Germany | |
| Wildeshausen, Germany | |
| Zwiesel, Germany | |
| Greece | |
| Athens, Greece | |
| Crete, Greece | |
| Komotini, Greece | |
| Larissa, Greece | |
| Patras, Greece | |
| Thessaloniki, Greece | |
| Italy | |
| Ferrara, Italy | |
| Ragusa, Italy | |
| Sassari, Italy | |
| Netherlands | |
| Rotterdam, Netherlands | |
| Spain | |
| Bueu (pontevedra), Spain | |
| Burela (lugo), Spain | |
| Catarroja, Spain | |
| La Eliana, Spain | |
| Ourense, Spain | |
| Paiporta, Spain | |
| Pamplona, Spain | |
| Pontevedra, Spain | |
| Puzol, Spain | |
| Quart de Poblet, Spain | |
| Redondela (pontevedra), Spain | |
| Sagunto, Spain | |
| San Cibrán. Aldán (pontevedra), Spain | |
| Santiago de Compostela, Spain | |
| Valencia, Spain | |
| Vigo, Spain | |
| Vilagarcía de Arosa (pontevedra), Spain | |
| Sweden | |
| Bromma, Sweden | |
| Eskilstuna, Sweden | |
| Malmö, Sweden | |
| Östersund, Sweden | |
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
| Study Director: | Anne FIQUET, MD | Sanofi Pasteur MSD |
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: | NCT00560755 History of Changes |
| Other Study ID Numbers: | MRV01C |
| Study First Received: | November 19, 2007 |
| Last Updated: | April 3, 2009 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Denmark: Danish Medicines Agency Sweden: Medical Products Agency The Netherlands: Ministry VWS (Ministerie van Volksgezondheid, Welzijn en Sport) Greece: National Organization of Medicines Spain: Spanish Agency of Medicines Italy: The Italian Medicines Agency |
Keywords provided by Sanofi Pasteur MSD:
|
Prevention of: measles, mumps, rubella and varicella |
Additional relevant MeSH terms:
|
Chickenpox Herpes Zoster Measles Mumps Parotitis Rubella Herpesviridae Infections DNA Virus Infections Virus Diseases Morbillivirus Infections Paramyxoviridae Infections |
Mononegavirales Infections RNA Virus Infections Rubulavirus Infections Parotid Diseases Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Sialadenitis Rubivirus Infections Togaviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013