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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00566527

MRV02C (Other Identifier)

V221-038

Details and patient eligibility

About

The primary study objectives are:

• To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
• To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
• To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well-tolerated compared to children of 12 months of age at the time of Dose 1.

The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 11 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.

If the first primary hypothesis was demonstrated, the second primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.

The secondary study objectives are:

• To describe the antibody titres to measles, mumps, rubella and varicella at Day 42 following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
• To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.

Enrollment: 1,620 patients

Sex: All

Ages: 9+ months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,620 participants in 3 patient groups

Arm 1: ProQuad® at 9 and 12 months

Experimental group

Description:

Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 at 12 months of age.

Treatment:

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

Arm 2: ProQuad® at 11 and 14 months

Experimental group

Description:

Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 at 14 months of age.

Treatment:

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

Arm 3: ProQuad at 12 and 15 months

Active Comparator group

Description:

Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 at 15 months of age.

Treatment:

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