Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00566527
• Date of registration: 29/11/2007
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)
• Scientific title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA Administered to Healthy Children From 9 Months of Age
• Date of first enrolment: November 29, 2007
• Target sample size: 1620
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00566527
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Finland, France, Germany

Contacts

• Name: Medical Director
• Affiliation: SPMSD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy subject of either gender of 9 months of age

2. Negative clinical history of measles, mumps, rubella, varicella or zoster

3. Informed consent form signed by both parents or legal representative

4. Parent(s) or legal representative able to attend all the scheduled visits with the
subject and to understand and comply with the study procedures

5. Both parent or legal representative are over 18 years of age

6. Subject is affiliated to a health social security system

Exclusion Criteria:

1. Febrile illness in the previous 3 days

2. Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone
or in any combination

3. Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days

4. Tuberculin test done in the previous 2 days

5. Severe chronic disease

6. Known active tuberculosis

7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or
unstable neurological condition

8. Hereditary problems of fructose intolerance

9. Prior known sensitivity or allergy to any component of the vaccine

10. Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
affecting the bone marrow or lymphatic systems

11. Humoral or cellular immunodeficiency,

12. Immunosuppressive therapy [including systemic corticosteroids (a), given daily or on
alternate days at high doses (>=2 mg/kg/day prednisone equivalent or >=20 mg/day if
the subject's weight was >10 kg) during at least 14 days in the previous 30 days]

13. Family history of congenital or hereditary immunodeficiency

14. Receipt of immunoglobulins or blood-derived products in the previous 150 days or
scheduled to be administered through Visit 5

15. Receipt of an inactivated vaccine in the previous 14 days

16. Receipt of a live non-study vaccine in the previous 28 days

17. Any medical condition which, in the opinion of the investigator, might have interfered
with the evaluation of the study objectives

18. Current participation or scheduled participation in any other clinical study through
Visit 5



Age minimum: 9 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Varicella

Measles

Rubella

Mumps

Intervention(s)

Biological: ProQuad® manufactured with recombinant Human Albumin (rHA)

Primary Outcome(s)

Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 [Time Frame: Day 132 (6 weeks after ProQuad® Dose 2)]

Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions [Time Frame: Up to Day 28 (up to 28 days after ProQuad® Dose 1)]

Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 [Time Frame: Day 132 (6 weeks after ProQuad® Dose 2)]

Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1 [Time Frame: Up to Day 28 (up to 28 days after ProQuad® Dose 1)]

Percentage of Participants With Rectal (or Rectal Equivalent) Temperature = 39.4°C [Time Frame: Up to Day 28 (up to 28 days after ProQuad® Dose 1)]

Percentage of Participants With Solicited Injection-site Adverse Reactions [Time Frame: Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1)]

Secondary Outcome(s)

Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1 [Time Frame: Day 42 (6 weeks after ProQuad® Dose 1)]

Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1 [Time Frame: Up to Day 28 (up to 4 weeks after ProQuad® Dose 1)]

Percentage of Participants With Varicella Antibody Titre = 1.25 gpELISA Units/mL [Time Frame: Day 132 (6 weeks after ProQuad® Dose 2)]

Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1 [Time Frame: Day 42 (6 weeks after ProQuad® Dose 1)]

GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2 [Time Frame: Day 132 (6 weeks after ProQuad® Dose 2)]

Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2 [Time Frame: Day 132 (6 weeks after ProQuad® Dose 2)]

Secondary ID(s)

V221-038

MRV02C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/01/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00566527