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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00402831
Other study ID # V221-036
Secondary ID F05-MMRV-3042006
Status Completed
Phase Phase 3
First received
Last updated
Start date October 6, 2006
Est. completion date May 11, 2007

Study information

Verified date August 2018
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary objective:

To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®

Secondary objectives:

- To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,

- To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,

- To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.


Recruitment information / eligibility

Status Completed
Enrollment 405
Est. completion date May 11, 2007
Est. primary completion date May 11, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 18 Months
Eligibility Inclusion Criteria:

- Healthy participant of either gender,

- Age 12 to 18 months,

- Negative clinical history of measles, mumps, rubella, varicella and zoster,

- Consent form signed by both holders of the parental authority or by the legal representative

- Holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

- Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,

- Any recent (=30 days) exposure to measles, mumps, rubella, varicella and/or zoster

- Any recent (=3 days) history of febrile illness

- Any severe chronic disease,

- Active untreated tuberculosis,

- Known personal history of seizure disorder,

- Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,

- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,

- Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (=14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (=2 mg/kg/day prednisone equivalent or =20 mg/day if weight more than 10 kg) within the previous 30 days] or other immunosuppressive therapy,

- Any previous (= 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through Visit 3,

- Any recent (=7 days) tuberculin test or scheduled tuberculin test through Visit 3,

- Any recent (=30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through Visit 3,

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
ProQuad®
Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response rates were determined as follows: measles antibody titre =255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre =10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre =10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre =5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. Week 10 (6 weeks after Dose 2 on Week 4)
Secondary Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined as follows: measles antibody titre =255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre =10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre =10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre =5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. Week 4
Secondary Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL. Week 4
Secondary Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres <10 ELISA Ab units mL. Week 4
Secondary Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL. Week 4
Secondary Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL. Week 4
Secondary Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL. Week 10 (6 weeks after Dose 2 on Week 4)
Secondary Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre <10 ELISA Ab units mL. Week 10 (6 weeks after Dose 2 on Week 4)
Secondary Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL. Week 10 (6 weeks after Dose 2 on Week 4)
Secondary Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL. Week 10 (6 weeks after Dose 2 on Week 4)
Secondary Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest. From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
Secondary Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest. From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)
Secondary Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
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