Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

Measles Clinical Trial

Official title:

Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children

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

• 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 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

External Links

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