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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_075 |
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Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.
Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTAâ„¢) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuadâ„¢) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnarâ„¢) will have a Duration of Treatment: 2 Doses, 6 months apart.
Vaccine: Hepatitis A Vaccine, Inactivated (VAQTAâ„¢), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Arm 1: VAQTAâ„¢ 0.5 mL injection (2 doses 6 months apart), ProQuadâ„¢ 0.5 mL injection (2 doses 6 months apart), Prevnarâ„¢ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration. |
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| 2 | Active Comparator | Arm 2: ProQuadâ„¢ 0.5 mL injection (2 doses ~8 months apart), Prevnarâ„¢ 0.5 mL injection (one dose), both administered concomitantly, VAQTAâ„¢ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: VAQTAâ„¢ (Hepatitis A vaccine) | Biological | VAQTAâ„¢ 0.5 mL injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response to Hepatitis A - Participants With a Serological Response | Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus | 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) |
| Antibody Response to Varicella - Participants With a Serological Response | Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection) | 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) |
| Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers | Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay | 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Participants With 1 or More Systemic Adverse Experience | Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 14) within the 6 week study period. | 6 weeks post dose 1 |
| Participants With 1 or More Systemic Adverse Experience | Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 14) within the 4 week study period. | 4 weeks post dose 2 |
| Participants With 1 or More Systemic Adverse Experience. |
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| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response to Hepatitis A - Geometric Mean Titer | Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus | 4 weeks Postdose 2 of hepatitis A vaccine (VAQTAâ„¢) |
| Antibody Response to Varicella - Geometric Mean Titer |
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 |
|---|---|---|---|
| 23744509 | Derived | Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schodel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6. |
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39 clinical sites in the United States
Date first participant visit: 14-Apr-2006
Date last participant visit: 25-Mar-2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: VAQTAâ„¢ + ProQuadâ„¢ + Prevnarâ„¢ | VAQTAâ„¢ (hepatitis A vaccine) + ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTAâ„¢ and ProQuadâ„¢ administered together 24 weeks later at third study visit. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: ProQuadâ„¢ (Measles, Mumps, Rubella and Varicella vaccine) |
| Biological |
ProQuadâ„¢ 0.5 mL injection |
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| Comparator: Prevnarâ„¢ (Pneumococcal 7-Valent Conjugate vaccine) | Biological | Prevnarâ„¢ 0.5 mL injection |
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Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 14), given 6 months apart |
| 6 months |
| Participants With 1 or More Injection-site Adverse Experience | Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 5) within the 6 week study period. | 6 weeks post dose 1 |
| Participants With 1 or More Injection-site Adverse Experience | Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 5) within the 4 week study period. | 4 weeks post dose 2 |
| Participants With 1 or More Injection-site Adverse Experience | Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered. | 6 months |
| Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period. | 6 weeks post dose 1 |
| Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period. | 4 weeks post dose 2 |
| Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered. | 6 months |
| Participants With 1 or More Serious Vaccine-related Adverse Experience | Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine | 6 weeks post dose 1 |
| Participants With 1 or More Serious Vaccine-related Adverse Experience | Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine | 4 weeks post dose 2 |
| Participants With 1 or More Serious Vaccine-related Adverse Experience | Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine | 6 months |
Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL
| 6 weeks Postdose 1 of varicella-containing vaccine (ProQuadâ„¢) |
| Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4 | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14 | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
| Arm 2: VAQTAâ„¢ Separate From ProQuadâ„¢ and Prevnarâ„¢ |
VAQTAâ„¢ (hepatitis A vaccine) dose 1 administered separately from ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) and Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTAâ„¢ administered 24 weeks after the first dose at third study visit. |
| Visit 1 |
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| Visit 2 |
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| Visit 3 |
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| Visit 4 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: VAQTAâ„¢ + ProQuadâ„¢ + Prevnarâ„¢ | VAQTAâ„¢ (hepatitis A vaccine) + ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTAâ„¢ and ProQuadâ„¢ administered together 24 weeks later at third study visit. |
| BG001 | Arm 2: VAQTAâ„¢ Separate From ProQuadâ„¢ and Prevnarâ„¢ | VAQTAâ„¢ (hepatitis A vaccine) dose 1 administered separately from ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) and Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTAâ„¢ administered 24 weeks after the first dose at third study visit. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Antibody Response to Hepatitis A - Participants With a Serological Response | Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus | Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures. | Posted | Number | Participants | 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) |
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| Primary | Antibody Response to Varicella - Participants With a Serological Response | Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection) | Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures. | Posted | Number | Participants | 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) |
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| Primary | Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers | Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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| Primary | Participants With 1 or More Systemic Adverse Experience | Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 14) within the 6 week study period. | Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 6 weeks post dose 1 |
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| Primary | Participants With 1 or More Systemic Adverse Experience | Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 14) within the 4 week study period. | Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 4 weeks post dose 2 |
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| Primary | Participants With 1 or More Systemic Adverse Experience. | Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 14), given 6 months apart | Includes all participants who provided safety follow-up after receipt of any dose of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 6 months |
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| Primary | Participants With 1 or More Injection-site Adverse Experience | Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 5) within the 6 week study period. | Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 6 weeks post dose 1 |
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| Primary | Participants With 1 or More Injection-site Adverse Experience | Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 5) within the 4 week study period. | Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 4 weeks post dose 2 |
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| Primary | Participants With 1 or More Injection-site Adverse Experience | Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTAâ„¢) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered. | Includes all participants who provided safety follow-up after receipt of any dose of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 6 months |
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| Primary | Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period. | Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine) | Posted | Number | Participants | 6 weeks post dose 1 |
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| Primary | Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period. | Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine) | Posted | Number | Participants | 4 weeks post dose 2 |
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| Primary | Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered. | Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine) | Posted | Number | Participants | 6 months |
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| Primary | Participants With 1 or More Serious Vaccine-related Adverse Experience | Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine | Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 6 weeks post dose 1 |
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| Primary | Participants With 1 or More Serious Vaccine-related Adverse Experience | Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine | Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 4 weeks post dose 2 |
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| Primary | Participants With 1 or More Serious Vaccine-related Adverse Experience | Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine | Includes all participants who provided safety follow-up after receipt of any dose of VAQTAâ„¢ (hepatitis A vaccine) | Posted | Number | Participants | 6 months |
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| Other Pre-specified | Antibody Response to Hepatitis A - Geometric Mean Titer | Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus | Per-protocol analysis set includes participants who received 2 doses of VAQTAâ„¢ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 4 weeks Postdose 2 of hepatitis A vaccine (VAQTAâ„¢) |
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| Other Pre-specified | Antibody Response to Varicella - Geometric Mean Titer | Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL | Per-protocol analysis set includes participants who received the initial dose of ProQuadâ„¢ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 6 weeks Postdose 1 of varicella-containing vaccine (ProQuadâ„¢) |
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| Other Pre-specified | Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4 | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes contained in Prevnarâ„¢. | Posted | Number | Participants | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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| Other Pre-specified | Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes contained in Prevnarâ„¢. | Posted | Number | Participants | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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| Other Pre-specified | Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes contained in Prevnarâ„¢. | Posted | Number | Participants | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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| Other Pre-specified | Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14 | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes contained in Prevnarâ„¢. | Posted | Number | Participants | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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| Other Pre-specified | Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes contained in Prevnarâ„¢. | Posted | Number | Participants | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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| Other Pre-specified | Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes contained in Prevnarâ„¢. | Posted | Number | Participants | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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| Other Pre-specified | Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response | Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F | Per-protocol analysis set includes participants who received Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes contained in Prevnarâ„¢. | Posted | Number | Participants | 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnarâ„¢) |
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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 | Arm 1: VAQTAâ„¢ + ProQuadâ„¢ + Prevnarâ„¢ | VAQTAâ„¢ (hepatitis A vaccine) + ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTAâ„¢ and ProQuadâ„¢ administered together 24 weeks later at third study visit. | 2 | 231 | ||||
| EG001 | Arm 2: VAQTAâ„¢ Separate From ProQuadâ„¢ and Prevnarâ„¢ | VAQTAâ„¢ (hepatitis A vaccine) dose 1 administered separately from ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) and Prevnarâ„¢ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTAâ„¢ administered 24 weeks after the first dose at third study visit. | 6 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Perineal Abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Genital Abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Otorrhea | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Eye Discharge | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Eye Swelling | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Body Temperature | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Multiple Allergies | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Adenovirus Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Body Tinea | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Candida Nappy Rash | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Conjunctivitis Bacterial | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Conjunctivitis Infective | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Conjunctivitis Viral | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Croup Infectious | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Enterobiasis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Eye Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Mycoplasma Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Otitis Media Acute | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tinea Pedis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral Pharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral Skin Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Hypervitaminosis A | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Penile Discharge | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bronchial Hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Paranasal Sinus Hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash Morbilliform | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash Rubelliform | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Rash Vesicular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Bruising, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Erythema, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nodule, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pain, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Reaction, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Swelling, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Warmth, Injection site for VAQTAâ„¢ | General disorders | MedDRA 11.0 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| D019433 | Chickenpox Vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D022283 | Herpesvirus Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
Not provided
Not provided
| Male |
|
Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound >-10.0). |
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