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

Measles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560755
• Other study ID #: V221-037
• Secondary ID: MRV01C2007-00243
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2007
• Last updated: September 18, 2017
• Start date: October 24, 2007
• Est. completion date: November 24, 2008

Study information

• Verified date: September 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3388
• Est. completion date: November 24, 2008
• Est. primary completion date: November 24, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 22 Months

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2	The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Vaccine-related AE 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.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2	The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.	Up to Day 46 (for 4 days following ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Unsolicited Injection-site AE 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.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Injection-site Rash of Interest AE 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.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2	Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2	Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE 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.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Mumps-like Illness 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.	Up to Day 70 (up to 28 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Serious AE (SAE) 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.	Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Primary	Percentage of Participants Experiencing a Vaccine-related SAE 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.	Up to Day 84 (up to 42 days after ProQuad® Dose 2)
Secondary	Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1	The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.	From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)
Secondary	Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1	Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.	Up to Day 28 (28 days after ProQuad® Dose 1)
Secondary	Percentage of Participants With = 1 Rectal Temperature Reading = 38.0° C After ProQuad® Dose 1	The percentage of participants with at least 1 rectal temperature reading = 38.0° C was determined.	Up to Day 28 (28 days after ProQuad® Dose 1)
Secondary	Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1	Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.	Up to Day 28 (28 days after ProQuad® Dose 1)