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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_668 |
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The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ProQuad + Placebo |
|
| 2 | Active Comparator | M-M-R II + Placebo |
|
| 3 | Active Comparator | M-M-R II + Varivax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) | Biological | A Single 0.5 mL subcutaneous injection at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Varicella | 6 weeks Postvaccination |
| Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Measles | 6 weeks Postvaccination |
| Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Mumps | 6 weeks Postvaccination |
| Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Rubella | 6 weeks Postvaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16452343 | Result | Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092. |
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Prior to entering study, all subjects received primary dose of M-M-R IIâ„¢ and Varivaxâ„¢ at less than or equal to 12 months of age.
17 clinical sites in the United States
Date of first participant visit: 24-Aug-2000
Date of last participant visit: 06-May-2002
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| ID | Title | Description |
|---|---|---|
| FG000 | ProQuadâ„¢ + Placebo | ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. |
| FG001 | M-M-Râ„¢ II + Placebo | M-M-Râ„¢ II + placebo administered concomitantly at separate injection sites on Day 1. |
| FG002 | M-M-Râ„¢ II + VARIVAXâ„¢ | VARIVAXâ„¢ + M-M-Râ„¢ II administered concomitantly at separate injection sites on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ProQuadâ„¢ + Placebo | ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. |
| BG001 | M-M-Râ„¢ II + Placebo |
| 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 | Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Varicella | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-Râ„¢ II + VARIVAXâ„¢ prior to entering the study, and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 6 weeks Postvaccination |
|
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The number of participants listed as "at risk" is the number of participants with follow-up.
0/0 indicates that subjects in this treatment group did not receive the indicated vaccine.
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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 | ProQuadâ„¢ + Placebo | ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis - Not other wise Specified (NOS) | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 6.0 | Non-systematic Assessment |
GMTs (adjusted for prevaccination titer, study center, and primary vaccination history status) have been reported in the literature. One subject received diluent only at visit 1 and was excluded from all immunogenicity/safety summaries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C050102 | measles, mumps, rubella, varicella vaccine |
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| Comparator: M-M-R II | Biological | A Single 0.5 mL subcutaneous injection at Day 1 |
|
| Comparator: Varivax | Biological | A Single 0.5 mL subcutaneous injection at Day 1 |
|
| Comparator: Placebo | Biological | A Single 0.5 mL subcutaneous placebo injection at Day 1 |
|
| Test not done |
|
| Other |
|
M-M-Râ„¢ II + placebo administered concomitantly at separate injection sites on Day 1.
| BG002 | M-M-Râ„¢ II + VARIVAXâ„¢ | VARIVAXâ„¢ + M-M-Râ„¢ II administered concomitantly at separate injection sites on Day 1. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
VARIVAXâ„¢ + M-M-Râ„¢ II administered concomitantly at separate injection sites on Day 1. |
|
|
| Primary | Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Measles | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-Râ„¢ II + VARIVAXâ„¢ prior to entering the study, and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 6 weeks Postvaccination |
|
|
|
| Primary | Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Mumps | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-Râ„¢ II + VARIVAXâ„¢ prior to entering the study, and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | ELISA AB units/mL | 6 weeks Postvaccination |
|
|
|
| Primary | Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to Rubella | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-Râ„¢ II + VARIVAXâ„¢ prior to entering the study, and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 6 weeks Postvaccination |
|
|
|
| 1 |
| 397 |
| 292 |
| 397 |
| EG001 | M-M-Râ„¢ II + Placebo | M-M-Râ„¢ II + placebo administered concomitantly at separate injection sites on Day 1. | 0 | 205 | 150 | 205 |
| EG002 | M-M-Râ„¢ II + VARIVAXâ„¢ | VARIVAXâ„¢ + M-M-Râ„¢ II administered concomitantly at separate injection sites on Day 1. | 0 | 193 | 140 | 193 |
| Conjunctivitis | Eye disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Pain NOS | General disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Venipuncture site pain | General disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Ear infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Gastroenteritis viral NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Otitis media NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Pneumonia NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Sinusitis NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Viral infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
|
| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Asthma NOS | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Bronchospasm NOS | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Injection site bruising (M-M-R II Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site erythema (M-M-R II Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site pain (M-M-R II Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site swelling (M-M-R II Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site bruising (ProQuad Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site erythema (ProQuad Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site pain (ProQuad Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site pruritus (ProQuad Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site rash (ProQuad Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site swelling (ProQuad Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site bruising (Varivax Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site erythema (Varivax Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site nodule (Varivax Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site pain (Varivax Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site pruritus (Varivax Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection site swelling (Varivax Injection-site) | General disorders | MedDRA 6.0 | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D007239 | Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |