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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_027 |
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The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Group 1: ProQuadâ„¢ (V221) + PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) followed by ProQuadâ„¢ (Day 91) |
|
| 2 | Experimental | Group 2: PREVNARâ„¢ followed by ProQuadâ„¢ (Day 43) followed by ProQuadâ„¢ (Day 133) |
|
| 3 | Experimental | Group 3: ProQuadâ„¢ followed by PREVNARâ„¢ (Day 43), followed by ProQuadâ„¢ (Day 91) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: ProQuadâ„¢ (V221) | Biological | 0.5-mL subcutaneous injection of measles, mumps, rubella, varicella virus vaccine live (MMRV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline. | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline. | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
| Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline. | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
| Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
| Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4 | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone | |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22123890 | Result | Leonardi M, Bromberg K, Baxter R, Gardner JL, Klopfer S, Nicholson O, Brockley M, Trammel J, Leamy V, Williams W, Kuter B, Schodel F. Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. 2011 Dec;128(6):e1387-94. doi: 10.1542/peds.2010-2132. Epub 2011 Nov 28. |
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24 clinical sites in the United States
Date first participant visit: 06-Mar-2006
Date last participant visit: 14-Sep-2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - ProQuadâ„¢ + PREVNARâ„¢ | Group 1 - ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuadâ„¢ administered at least 90 days (Day 91) after the first dose. |
| FG001 | Group 2 - PREVNARâ„¢ Followed by ProQuadâ„¢ | Group 2 - Fourth dose of PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuadâ„¢ administered at least 90 days (Day 133) after the first dose. |
| FG002 | Group 3 - ProQuadâ„¢ Followed by PREVNARâ„¢ | Group 3 - ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuadâ„¢ administered at least 90 days (Day 91) after the first dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - ProQuadâ„¢ + PREVNARâ„¢ | Group 1 - ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuadâ„¢ administered at least 90 days (Day 91) after the first dose. |
| BG001 |
| 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 | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to Measles at Baseline. | 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 | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
|
28 days post-dose
The number of participants listed as "at risk" is the number of participants with follow-up.
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 | ProQuadâ„¢ + Prevnarâ„¢ (After Dose 1) | ProQuadâ„¢ + Prevnarâ„¢ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuadâ„¢ (safety follow-up period 1 for Group 1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA Version 10.1 | Non-systematic Assessment |
One subject (Group 3-ProQuadâ„¢ followed by PREVNARâ„¢) was diagnosed (Day 8) with Stage IV neuroblastoma (considered not related to study vaccine by investigator) and discontinued from the study. Subject died (Day 218) due to neuroblastoma.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C050102 | measles, mumps, rubella, varicella vaccine |
| D022242 | Pneumococcal Vaccines |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
Not provided
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|
| Comparator: PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) | Biological | 0.5-mL intramuscular injection of pneumococcal 7-valent conjugate vaccine |
|
|
| 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
| Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone. |
| Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
| Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14 | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
| Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
| Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
| Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
| 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14 | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Subject Moved |
|
| Other |
|
| Group 2 - PREVNARâ„¢ Followed by ProQuadâ„¢ |
Group 2 - Fourth dose of PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuadâ„¢ administered at least 90 days (Day 133) after the first dose. |
| BG002 | Group 3 - ProQuadâ„¢ Followed by PREVNARâ„¢ | Group 3 - ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuadâ„¢ administered at least 90 days (Day 91) after the first dose. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Group 3 - ProQuadâ„¢ Followed by PREVNARâ„¢ | Group 3 - ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNARâ„¢ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuadâ„¢ administered at least 90 days (Day 91) after the first dose. |
|
|
| Primary | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline. | 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 | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
|
|
|
| Primary | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline. | 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 | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
|
|
|
| Primary | Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone |
|
|
|
| Other Pre-specified | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4 | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
|
|
|
| Other Pre-specified | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
|
|
|
| Other Pre-specified | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
|
|
|
| Other Pre-specified | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14 | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
|
|
|
| Other Pre-specified | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
|
|
|
| Other Pre-specified | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
|
|
|
| Other Pre-specified | Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone |
|
|
|
| Primary | Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4 | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
|
|
|
| Primary | Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone. |
|
|
|
| Primary | Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
|
|
|
| Primary | Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14 | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
|
|
|
| Primary | Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
|
|
|
| Primary | Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
|
|
|
| Primary | Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer | Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 6 weeks Postvaccination in subjects receiving ProQuadâ„¢ concomitantly with a fourth dose of Prevnarâ„¢ and in subjects receiving a fourth dose of Prevnarâ„¢ alone |
|
|
|
| 4 |
| 498 |
| 367 |
| 498 |
| EG001 | ProQuadâ„¢ Alone (After Dose 1) | ProQuadâ„¢ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuadâ„¢ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2). | 3 | 495 | 311 | 495 |
| EG002 | ProQuadâ„¢ (After Dose 2) | ProQuadâ„¢ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuadâ„¢ (safety follow-up period 3 for Group 1, Group 2, and Group 3). | 0 | 910 | 499 | 910 |
| Pneumonia Viral | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Croup Infectious | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Febrile Convulsion | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Neuroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Otitis Media Acute | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Immune system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Viral Rash | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Arthropod Bite | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Rash Morbilliform | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Rash Vesicular | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Injection Site Bruising (Prevnar Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Injection Site Erythema (Prevnar Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
|
| Injection Site Pain (Prevnar Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
|
| Injection Site Rash (Prevnar Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Injection Site Swelling (Prevnar Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
|
| Injection Site Bruising (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Injection Site Erythema (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
|
| Injection Site Pain (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
|
| Injection Site Rash (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Injection Site Swelling (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | 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 |
| D045424 |
| Complex Mixtures |
| D017778 | Vaccines, Combined |