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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00985153
Other study ID # V221-012
Secondary ID 2009_669
Status Completed
Phase Phase 3
First received September 25, 2009
Last updated November 20, 2015
Start date March 2000
Est. completion date May 2001

Study information

Verified date November 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

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.


Recruitment information / eligibility

Status Completed
Enrollment 3927
Est. completion date May 2001
Est. primary completion date May 2001
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

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A Single 0.5 mL subcutaneous injection at Day 0
Comparator: Varivax
A Single 0.5 mL subcutaneous injection at Day 0
Comparator: M-M-R II
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)

Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schödel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, m — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Postvaccination Varicella Antibody Titer = 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline 6 weeks Postvaccination No
Primary Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer = 120 mIU/mL Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline 6 weeks Postvaccination No
Primary Number of Participants With Postvaccination Mumps ELISA Antibody Titer = 10 Ab Units/mL Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline 6 weeks Postvaccination No
Primary Number of Participants With Postvaccination Rubella ELISA Antibody Titer = 10 IU/mL Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline 6 weeks Postvaccination No
Primary Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to Varicella 6 weeks Postvaccination No
Primary Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to Measles. 6 weeks Postvaccination No
Primary Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to Mumps. 6 weeks Postvaccination No
Primary Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer Postvaccination observed Geometric Mean Titer of antibody to Rubella 6 weeks Postvaccination No
Primary Number of Participants With Serious Vaccine-related CAEs Subjects 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 No
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