Measles, Mumps, Rubella, Varicella
Conditions
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.
Interventions
BIOLOGICALProQuad®
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Week 10 (6 weeks after Dose 2 on Week 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Week 4 | 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. |
| Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose | Week 4 | 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. |
| Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose | Week 4 | 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. |
| Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose | Week 4 | 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. |
| Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose | Week 4 | 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. |
| Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose | From Day 30 up to Day 58 (up to 28 days 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. |
| Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment | Week 10 (6 weeks after Dose 2 on Week 4) | 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. |
| Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment | Week 10 (6 weeks after Dose 2 on Week 4) | 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. |
| Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment | Week 10 (6 weeks after Dose 2 on Week 4) | 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. |
| Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose | From Day 0 up to Day 28 (up to 28 days 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. |
| Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose | From Day 0 up to Day 28 (up to 28 days 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. |
| Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment | Week 10 (6 weeks after Dose 2 on Week 4) | 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. |
Participant flow
Recruitment details
A total of 411 male and female participants (12 to 18 months of age) were selected for study entry at 33 sites in France. A total of 405 participants were randomized and received 2 doses of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Intramuscular ProQuad® Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days. | 202 |
| Subcutaneous ProQuad® Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection 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. Doses were separated by 30 to 44 days. | 203 |
| Total | 405 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Non-compliance with protocol | 0 | 1 |
Baseline characteristics
| Characteristic | Intramuscular ProQuad® | Subcutaneous ProQuad® | Total |
|---|---|---|---|
| Age, Continuous | 13.72 Months STANDARD_DEVIATION 1.44 | 13.65 Months STANDARD_DEVIATION 1.53 | 13.68 Months STANDARD_DEVIATION 1.48 |
| Sex: Female, Male Female | 105 Participants | 94 Participants | 199 Participants |
| Sex: Female, Male Male | 97 Participants | 109 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 153 / 202 | 166 / 203 | 141 / 201 | 137 / 200 |
| serious Total, serious adverse events | 2 / 202 | 2 / 203 | 1 / 201 | 1 / 200 |
Outcome results
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.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Population: Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Measles | 100 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Mumps | 99.3 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Rubella | 100 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Varicella | 100 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Varicella | 99.3 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Measles | 100 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Rubella | 99.2 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Mumps | 99.3 Percentage of participants |
Comparison: Measles difference95% CI: [-2.5, 2.6]
Comparison: Mumps difference95% CI: [-3, 3.3]
Comparison: Rubella difference95% CI: [-2.3, 4.1]
Comparison: Varicella95% CI: [-2.1, 4.1]
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.
Time frame: Week 4
Population: Participants who were initially seronegative to measles and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose | 4058.7 Antibody titres (mIU/mL) |
| Subcutaneous ProQuad® | Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose | 3327.0 Antibody titres (mIU/mL) |
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.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Population: Participants who were initially seronegative to measles and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment | 3953.7 Antibody titres (mIU/mL) |
| Subcutaneous ProQuad® | Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment | 3748.6 Antibody titres (mIU/mL) |
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.
Time frame: Week 4
Population: Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose | 120.0 Antibody titres (ELISA Ab units/mL) |
| Subcutaneous ProQuad® | Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose | 101.9 Antibody titres (ELISA Ab units/mL) |
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.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Population: Participants who were initially seronegative to mumps and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment | 157.9 Antibody titres (ELISA Ab units/mL) |
| Subcutaneous ProQuad® | Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment | 168.8 Antibody titres (ELISA Ab units/mL) |
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.
Time frame: Week 4
Population: Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose | 46.9 Antibody titres (IU/mL) |
| Subcutaneous ProQuad® | Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose | 50.9 Antibody titres (IU/mL) |
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.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Population: Participants who were initially seronegative to rubella and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment | 92.8 Antibody titres (IU/mL) |
| Subcutaneous ProQuad® | Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment | 94.2 Antibody titres (IU/mL) |
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.
Time frame: Week 4
Population: Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose | 25.0 Antibody titres (gpELISA units/mL) |
| Subcutaneous ProQuad® | Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose | 23.6 Antibody titres (gpELISA units/mL) |
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.
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Population: Participants who were initially seronegative to varicella and who had post-vaccination serology results were included.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Intramuscular ProQuad® | Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment | 358.1 Antibody titres (gpELISA units/mL) |
| Subcutaneous ProQuad® | Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment | 261.8 Antibody titres (gpELISA units/mL) |
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.
Time frame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intramuscular ProQuad® | Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose | 0 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose | 0 Percentage of participants |
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.
Time frame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
Population: All participants who received at least one dose of study drug and had safety follow-up data are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular ProQuad® | Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose | Injection-site AEs | 17.8 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose | Vaccine-related systemic AEs | 8.9 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose | Injection-site AEs | 28.6 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose | Vaccine-related systemic AEs | 8.4 Percentage of participants |
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.
Time frame: From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)
Population: All participants who received at least one dose of study drug and had safety follow-up data are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular ProQuad® | Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose | Injection-site AEs | 20.4 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose | Vaccine-related systemic AEs | 6.0 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose | Injection-site AEs | 29.5 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose | Vaccine-related systemic AEs | 5.0 Percentage of participants |
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.
Time frame: Week 4
Population: Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Measles | 100 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Mumps | 97.4 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Rubella | 98.4 Percentage of participants |
| Intramuscular ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Varicella | 98.6 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Varicella | 98.5 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Measles | 97.3 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Rubella | 100 Percentage of participants |
| Subcutaneous ProQuad® | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Mumps | 91.3 Percentage of participants |