Phase 3
N=405
ProQuad® Intramuscular vs Subcutaneous
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00402831 ↗Enrolled (actual)
405
Serious AEs
0.7%
Results posted
Aug 2018
Primary outcome: Primary: Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment — 100; 100; 99.3; 99.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ProQuad® (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment |
100; 100; 99.3; 99.3; 100; 99.2 | — |
| SECONDARY Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose |
100; 97.3; 97.4; 91.3; 98.4; 100 | — |
| SECONDARY Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose |
4058.7; 3327.0 | — |
| SECONDARY Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose |
120.0; 101.9 | — |
| SECONDARY Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose |
46.9; 50.9 | — |
| SECONDARY Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose |
25.0; 23.6 | — |
| SECONDARY Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment |
3953.7; 3748.6 | — |
| SECONDARY Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment |
157.9; 168.8 | — |
| SECONDARY Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment |
92.8; 94.2 | — |
| SECONDARY Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment |
358.1; 261.8 | — |
| SECONDARY Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose |
17.8; 28.6; 8.9; 8.4 | — |
| SECONDARY Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose |
20.4; 29.5; 6.0; 5.0 | — |
| SECONDARY Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose |
0; 0 | — |
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.
Eligibility Criteria
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,
Data sourced from ClinicalTrials.gov (NCT00402831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.