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

NCT ID: NCT00566527

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-29
• Study Completion Date: 2008-12-29

Brief Summary

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.

Conditions

Measles; Mumps; Rubella; Varicella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1: ProQuad® at 9 and 12 months

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

Group Type: EXPERIMENTAL

ProQuad® manufactured with recombinant Human Albumin (rHA)

Intervention Type: BIOLOGICAL

A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).

Arm 2: ProQuad® at 11 and 14 months

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

Group Type: EXPERIMENTAL

ProQuad® manufactured with recombinant Human Albumin (rHA)

Intervention Type: BIOLOGICAL

A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).

Arm 3: ProQuad at 12 and 15 months

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

Group Type: ACTIVE_COMPARATOR

ProQuad® manufactured with recombinant Human Albumin (rHA)

Intervention Type: BIOLOGICAL

A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).

Interventions

ProQuad® manufactured with recombinant Human Albumin (rHA)

A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

SPMSD

References

Vesikari T, Becker T, Gajdos V, Fiquet A, Thomas S, Richard P, Baudin M. Immunogenicity and safety of a two-dose regimen of a combined measles, mumps, rubella and varicella live vaccine (ProQuad((R))) in infants from 9 months of age. Vaccine. 2012 Apr 26;30(20):3082-9. doi: 10.1016/j.vaccine.2012.02.062. Epub 2012 Mar 7.

Reference Type: DERIVED

PMID: 22406278 (View on PubMed)

Other Identifiers

MRV02C

Identifier Type: OTHER

Identifier Source: secondary_id

V221-038

Identifier Type: -

Identifier Source: org_study_id