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Safety Study of ProQuad® rHA in Infants (V221-037)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560755
First Posted: November 20, 2007
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (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® Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.

  • Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.

  • Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2 [ Time Frame: Up to Day 46 (for 4 days following ProQuad® Dose 2) ]
    The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.

  • Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.

  • Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.

  • Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.

  • Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.

  • Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.

  • Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2 [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]
    The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.

  • Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2 [ Time Frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2) ]
    Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.

  • Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2 [ Time Frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2) ]
    Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.


Secondary Outcome Measures:
  • Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1 [ Time Frame: From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1) ]
    The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.

  • Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1 [ Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1) ]
    Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.

  • Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1 [ Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1) ]
    The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.

  • Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1 [ Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1) ]
    Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.


Enrollment: 3388
Actual Study Start Date: October 24, 2007
Study Completion Date: November 24, 2008
Primary Completion Date: November 24, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ProQuad®
Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
Biological: ProQuad®
ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 22 Months   (Child)
Sexes Eligible for Study:   All
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
  • Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of study objectives
  • Participation in another clinical study in the past 30 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560755


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Anne FIQUET, MD MCM Vaccines B.V.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00560755     History of Changes
Other Study ID Numbers: V221-037
MRV01C ( Other Identifier: Sanofi Pasteur MSD Protocol Number )
2007-002438-12 ( EudraCT Number )
First Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: September 18, 2017
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme Corp.:
Prevention of: measles, mumps, rubella and varicella

Additional relevant MeSH terms:
Measles
Chickenpox
Herpes Zoster
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections