ProQuad® Intramuscular vs Subcutaneous

NCT00402831 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V221-036F05-MMRV-3042006-001986-40
• Study Type: interventional
• Target: 405
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Measles; Mumps; Rubella; Varicella

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose

  Week 4

• Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose

  Week 4

• Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose

  Week 4

• Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose

  Week 4

• Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose

  Week 4

Study Arms (2)

Intramuscular ProQuad®

EXPERIMENTAL

Participants will receive doses of ProQuad® by IM injection on Day 1 and Day 30 into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm.

Biological: ProQuad®

Subcutaneous ProQuad®

ACTIVE COMPARATOR

Participants will receive doses of ProQuad® by SC injection on Day 1 and Day 30 in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm.

Biological: ProQuad®

Interventions

ProQuad® BIOLOGICAL

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.

Intramuscular ProQuad®; Subcutaneous ProQuad®

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Haas H, Richard P, Eymin C, Fiquet A, Kuter B, Soubeyrand B. Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles, mumps, rubella, and varicella vaccine to children 12 to 18 months of age. Hum Vaccin Immunother. 2019;15(4):778-785. doi: 10.1080/21645515.2018.1549452. Epub 2019 Jan 8.

  PMID: 30481110 DERIVED

MeSH Terms

Conditions

Measles; Mumps; Rubella; Chickenpox

Interventions

measles, mumps, rubella, varicella vaccine

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Anne FIQUET, MD

  SPMSD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 22, 2006
• Study Start: October 6, 2006
• Primary Completion: May 11, 2007
• Study Completion: May 11, 2007
• Last Updated: August 13, 2018
• Results First Posted: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share