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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_666 |
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This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ProQuad + Tripedia + Comvax at Day 0 (Concomitant) |
|
| 2 | Experimental | ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant) |
|
| 3 | Active Comparator | Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live | Biological | A single 0.5 mL subcutaneous injection at Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline | 6 Weeks Postvaccination |
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL | Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL | Antibody response to Diphtheria at 6 weeks postvaccination | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL | Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 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 |
|---|---|---|---|
| 16567978 | Result | Shinefield H, Black S, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, Schodel F, Brown ML, Kuter B; 013 Study Group for ProQuad. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined Haemophilus influenzae type b conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Pediatr Infect Dis J. 2006 Apr;25(4):287-92. doi: 10.1097/01.inf.0000207857.10947.1f. |
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48 clinical sites in the United States
Date first participant visit: 27-Jun-2000
Date last participant visit: 23-Oct-2001
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| ID | Title | Description |
|---|---|---|
| FG000 | Concomitant Group | Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Comparator: Tripedia | Biological | A single 0.5 mL intramuscular injection (at Day 0 or Day 42) |
|
| Comparator: Comvax | Biological | A single 0.5 mL intramuscular injection (at Day 0 or Day 42) |
|
| Comparator: Varivax | Biological | A single 0.5 mL subcutaneous injection at Day 0 |
|
| Comparator: M-M-R II | Biological | A single 0.5 mL subcutaneous injection at Day 0 |
|
| 6 weeks Postvaccination |
| Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer | Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA). | 6 weeks Postvaccination |
| Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer | Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA). | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL | Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)). | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL | Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.) | 6 weeks Postvaccination |
| Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.) | 6 weeks Postvaccination |
| Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT | Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.) | 6 weeks Postvaccination |
| Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.) | 6 weeks Postvaccination |
| Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.) | 6 weeks Postvaccination |
| Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.) | 6 weeks Postvaccination |
| Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA). | 6 weeks Postvaccination |
| Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).) | 6 weeks Postvaccination |
| Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).) | 6 weeks Postvaccination |
| Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT | Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.) | 6 weeks Postvaccination |
| Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).) | 6 weeks Postvaccination |
| Nonconcomitant Group |
Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. |
| FG002 | Control Group | Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. |
| Visit 1 |
|
| Visit 2 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Concomitant Group | Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0. |
| BG001 | Nonconcomitant Group | Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. |
| BG002 | Control Group | Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 Weeks Postvaccination |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL | Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL | Antibody response to Diphtheria at 6 weeks postvaccination | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL | Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination. | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer | Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA). | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer | Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA). | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL | Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)). | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL | Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.) | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.) | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT | Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.) | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | ELISA Ab units/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.) | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.) | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.) | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA). | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | units/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).) | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | units/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).) | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT | Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.) | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 6 weeks Postvaccination |
| |||||||||||||||||||||||||||||||||
| Primary | Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT | Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).) | The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 6 weeks Postvaccination |
|
Participants were followed for safety for 42 days after Visit 1 and 14 days after Visit 2 (56 days total).
Number of participants reported as "At Risk" is the number of participants with follow-up.
Although a subject may have had 2 or more adverse experiences, the subject is counted only once within a category. The same subject may appear in different categories.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Concomitant Group | Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0. | 11 | 929 | 831 | 929 | ||
| EG001 | Nonconcomitant Group | Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. | 3 | 479 | 435 | 479 | ||
| EG002 | Control Group | Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. | 1 | 467 | 411 | 467 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Merck CRISP | Systematic Assessment |
| |
| Hernia, inguinal | Musculoskeletal and connective tissue disorders | Merck CRISP | Non-systematic Assessment |
| |
| Infection, viral | Infections and infestations | Merck CRISP | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | Merck CRISP | Non-systematic Assessment |
| |
| Allergy, food | Immune system disorders | Merck CRISP | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | Merck CRISP | Non-systematic Assessment |
| |
| Afebrile seizure | Nervous system disorders | Merck CRISP | Non-systematic Assessment |
| |
| Seizure, febrile | Nervous system disorders | Merck CRISP | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Laryngotracheobronchitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | Merck CRISP | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Cellulitis, orbital | Infections and infestations | Merck CRISP | Non-systematic Assessment |
| |
| Necrosis, testicle | Reproductive system and breast disorders | Merck CRISP | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Merck CRISP | Systematic Assessment |
| |
| Infection, Viral | Infections and infestations | Merck CRISP | Non-systematic Assessment |
| |
| Malaise | General disorders | Merck CRISP | Non-systematic Assessment |
| |
| Pain | General disorders | Merck CRISP | Non-systematic Assessment |
| |
| Trauma | Injury, poisoning and procedural complications | Merck CRISP | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | Merck CRISP | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Gastroenteritis, Infectious | Infections and infestations | Merck CRISP | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Allergy | Immune system disorders | Merck CRISP | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | Merck CRISP | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Congestion, Nasal | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Congestion, Respiratory | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Infection, Respiratory, Upper | Infections and infestations | Merck CRISP | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | Merck CRISP | Non-systematic Assessment |
| |
| Laryngotracheobronchitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Rhinitis | Reproductive system and breast disorders | Merck CRISP | Non-systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
| |
| Bite/Sting, Non-Venomous | Injury, poisoning and procedural complications | Merck CRISP | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | Merck CRISP | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
| |
| Dermatitis, Contact | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
| |
| Excoriation | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
| |
| Miliaria Rubra | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
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| Rash, Diaper | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
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| Rash, Measles/Rubella-Like | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Rash, Varicella-Like | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
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| Viral Exanthema | Infections and infestations | Merck CRISP | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | Merck CRISP | Non-systematic Assessment |
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| Otitis | Ear and labyrinth disorders | Merck CRISP | Non-systematic Assessment |
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| Otitis Media | Ear and labyrinth disorders | Merck CRISP | Non-systematic Assessment |
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| Pain, Ear | Ear and labyrinth disorders | Merck CRISP | Non-systematic Assessment |
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| Ecchymosis (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
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| Erythema (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Pain/Tenderness/Soreness (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Rash (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
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| Swelling (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Erythema (Varivax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Pain/Tenderness/Soreness (Varivax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Swelling (Varivax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Erythema (M-M-R II Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Pain/Tenderness/Soreness (M-M-R II Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Swelling (M-M-R II Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Ecchymosis (Tripedia Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
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| Erythema (Tripedia Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Pain/Tenderness/Soreness (Tripedia Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Swelling (Tripedia Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
| |
| Ecchymosis (Comvax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
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| Erythema (Comvax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
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| Induration (Comvax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
| |
| Pain/Tenderness/Soreness (Comvax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
| |
| Swelling (Comvax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
Two participants were incorrectly vaccinated and are not included in the efficacy/safety analyses. One received M-M-R™II+TRIPEDIA™+COMVAX™ and 1 received VARIVAX™+TRIPEDIA™+COMVAX™ instead of ProQuad™+TRIPEDIA™+COMVAX™
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C050102 | measles, mumps, rubella, varicella vaccine |
Not provided
Not provided
Not provided
| Male |
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| Asian/Pacific |
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| Caucasian |
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| Hispanic |
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| Native American |
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| Other |
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Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. |
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Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42. |
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Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
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Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
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Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
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Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
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