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This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VARIVAX™ NSP + M-M-R II™ | Experimental | VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 |
|
| VARIVAX™ 2007 Process + M-M-R II™ | Active Comparator | VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VARIVAX™ New Seed Process | Biological | Varicella virus vaccine live manufactured with a new seed process |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL | 6 weeks (43 days) after vaccination 1 | |
| Geometric Mean Titer of VZV Antibodies | Antibody titers were measured with gpELISA. | 6 weeks (43 days) after vaccination 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Fever (>=102.2 °F Oral Equivalent) | Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days) | |
| Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29087781 | Result | Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VARIVAX™ New Seed Process + M-M-R II™ | VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91. |
| FG001 | VARIVAX™ 2007 Process + M-M-R II™ | VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | VARIVAX™ New Seed Process + M-M-R II™ | VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91. |
| BG001 | VARIVAX™ 2007 Process + M-M-R II™ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL | The analysis population is participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis. | Posted | Number | Percentage of participants | 6 weeks (43 days) after vaccination 1 |
|
SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VARIVAX™ New Seed Process + M-M-R II™ | VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowning | General disorders | MedDRA version 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme, Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| VARIVAX™ 2007 process | Biological | Varicella virus vaccine live manufactured with the 2007 process |
|
| M-M-R II™ | Biological | Measles, Mumps, and Rubella virus vaccine live |
|
| Up to 42 days after Vaccination 1 |
| Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2 | Up to 42 days after Vaccination 2 |
| Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1 | Up to 5 days after Vaccination 1 |
| Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2 | Up to 5 days after Vaccination 2 |
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Geometric Mean Titer of VZV Antibodies | Antibody titers were measured with gpELISA. | The analysis population is participants with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 6 weeks (43 days) after vaccination 1 |
|
|
|
|
| Secondary | Percentage of Participants With Fever (>=102.2 °F Oral Equivalent) | The analysis population is All Subjects as Treated with temperature data at the time of assessment. | Posted | Number | Percentage of participants | Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days) |
|
|
|
| Secondary | Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1 | The analysis population is All Subjects as Treated with results after Vaccination 1. | Posted | Number | Percentage of participants | Up to 42 days after Vaccination 1 |
|
|
|
| Secondary | Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2 | The analysis population is All Subjects as Treated with results after vaccination 2 | Posted | Number | Percentage of participants | Up to 42 days after Vaccination 2 |
|
|
|
| Secondary | Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1 | The analysis population is All Subjects as Treated with results after Vaccination 1. | Posted | Number | Percentage of participants | Up to 5 days after Vaccination 1 |
|
|
|
| Secondary | Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2 | The analysis population is All Subjects as Treated with results after vaccination 2. | Posted | Number | Percentage of participants | Up to 5 days after Vaccination 2 |
|
|
|
| 6 |
| 291 |
| 225 |
| 291 |
| EG001 | VARIVAX™ 2007 Process + M-M-R II™ | VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91. | 9 | 293 | 224 | 293 |
| Bronchiolitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA version 18.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 18.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| D007239 | Infections |
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being >76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).
| Exact CI method/binomial proportion |
| <0.001 |
| Antibody Response Rate |
| 97.2 |
| 2-Sided |
| 95 |
| 94.4 |
| 98.9 |
| Superiority or Other |
| Varicella-like Rash |
|
| Mumps-like Symptoms |
|
| Injection-site Rash |
|
| Varicella-like Rash |
|
| Mumps-like Symptoms |
|
| Injection-site Rash |
|
| Injection-site Pain/Tenderness |
|
| Injection-site Pain/Tenderness |
|