ProQuad Dose Selection Study (V221-011)(COMPLETED)

Measles Clinical Trial

Official title:

A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986232
• Other study ID #: V221-011
• Secondary ID: 2009_667
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2009
• Last updated: March 23, 2015
• Start date: April 1999
• Est. completion date: September 2000

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1551
• Est. completion date: September 2000
• Est. primary completion date: April 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• In good health

• Negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

• Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination

• Any immune impairment or deficiency

• Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination

• Vaccination with an inactive vaccine with in the past 14 days

• Vaccination with a live vaccine within the past 30 days

• Immune globulin or any blood product administered in the past 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Biological:
• Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
• Comparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
• Comparator: PUVV
A single 0.5 mL subcutaneous injection at Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schödel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer = 5 gpELISA Units	Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units	6 weeks postvaccination	No
Secondary	Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer = 207.5 mIU/mL	Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline	6 weeks postvaccination	No
Secondary	Number of Participants With Postvaccination Mumps ELISA Antibody Titer = 2.0 Ab Units/mL	Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline	6 weeks Postvaccination	No
Secondary	Number of Participants With Postvaccination Rubella ELISA Antibody Titer = 10 IU/mL	Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline	6 weeks Postvaccination	No
Secondary	Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)	Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).	6 weeks Postvaccination Visit 1 or Visit 2	Yes
Secondary	Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)	Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)	6 weeks Postvaccination	No
Secondary	Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)	Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)	6 weeks Postvaccination	No
Secondary	Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)	Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)	6 weeks Postvaccination	No
Secondary	Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)	Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)	6 weeks postvaccination	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site