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This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.
Primary Objectives:
Observational Objectives:
Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups.
Immunogenicity:
- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.
No meningococcal vaccine is presently licensed for the population aged < 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged < 2 years would address this important, currently unmet public health need.
At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.
Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menactra® at 9 and 12 Months | Experimental | Participants will received Menactra® vaccination at 9 and 12 months of age. |
|
| Menactra® at 9 Months and Menactra® + MMRV at 12 Months | Experimental | Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age |
|
| Menactra® at 9 Months and Menactra® + PCV at 12 Months | Experimental | Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
|
| MMRV + PCV at 12 Months | Active Comparator | Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide Diphtheria Conjugate Vaccine | Biological | 0.5 mL dose, intramuscular (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella. | Day 30 after the 12-month vaccination |
| Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Day 30 after the 12-month vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Day 30 after 12-month vaccination | |
| Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age |
Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa | Alabama | 35401 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented.
625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report.
Participants were enrolled from 15 January 2007 to 16 March 2008 in 92 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Menactra® at 9 and 12 Months | Participants who received only Menactra® vaccination at 9 and 12 months of age |
| FG001 | Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Meningococcal Polysaccharide Diphtheria Conjugate Vaccine | Biological | 0.5 mL dose, IM |
|
|
| Meningococcal Polysaccharide Diphtheria Conjugate Vaccine | Biological | 0.5 Ml dose, IM |
|
|
| Measles, Mumps, Rubella and Varicella | Biological | 0.5 mL dose, SC |
|
|
Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.
Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
| Days 0 to 7 after vaccination |
| Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Days 0 to 7 after vaccination |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Jonesboro | Arkansas | 72401 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Atascadero | California | 93422 | United States |
| Fresno | California | 93726 | United States |
| Paramount | California | 90723 | United States |
| Roseville | California | 95661 | United States |
| Sacramento | California | 95823 | United States |
| San Jose | California | 95119 | United States |
| Torrance | California | 90502 | United States |
| Aurora | Colorado | 80012 | United States |
| Norwich | Connecticut | 06360 | United States |
| Viera | Florida | 32940 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Dalton | Georgia | 30721 | United States |
| Marietta | Georgia | 30062 | United States |
| Tifton | Georgia | 31794 | United States |
| Woodstock | Georgia | 30189 | United States |
| Chicago | Illinois | 60614 | United States |
| Chicago | Illinois | 60647 | United States |
| Fishers | Indiana | 46038 | United States |
| Dubuque | Iowa | 52001 | United States |
| Dubuque | Iowa | 52002 | United States |
| Owensboro | Kentucky | 42303 | United States |
| Bossier City | Louisiana | 71111 | United States |
| Perry Hall | Maryland | 21128 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Niles | Michigan | 49120 | United States |
| Stevensville | Michigan | 49127 | United States |
| Bridgeton | Missouri | 63044 | United States |
| Kansas City | Missouri | 64108 | United States |
| Saint Charles | Missouri | 63303 | United States |
| St Louis | Missouri | 63104 | United States |
| Bellevue | Nebraska | 68123 | United States |
| La Vista | Nebraska | 68128 | United States |
| Omaha | Nebraska | 68117 | United States |
| Omaha | Nebraska | 68124 | United States |
| Omaha | Nebraska | 68131 | United States |
| Omaha | Nebraska | 68132 | United States |
| Henderson | Nevada | 89105 | United States |
| Whitehouse Station | New Jersey | 08889 | United States |
| Brooklyn | New York | 11201 | United States |
| Fishkill | New York | 12524 | United States |
| Hopewell Junction | New York | 12533 | United States |
| Ithaca | New York | 14850 | United States |
| Lake Success | New York | 11021 | United States |
| Mineola | New York | 11501 | United States |
| New York | New York | 10016 | United States |
| Poughkeepsie | New York | 12603 | United States |
| Syracuse | New York | 13210 | United States |
| Boone | North Carolina | 28607 | United States |
| Clyde | North Carolina | 28721 | United States |
| Durham | North Carolina | 27704 | United States |
| Durham | North Carolina | 27705 | United States |
| Beachwood | Ohio | 44122 | United States |
| Cleveland | Ohio | 44121 | United States |
| Cleveland | Ohio | 44195 | United States |
| Independence | Ohio | 44131 | United States |
| Strongsville | Ohio | 44136 | United States |
| Harleysville | Pennsylvania | 19438 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Pittsburgh | Pennsylvania | 15220 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Wexford | Pennsylvania | 15090 | United States |
| Clarksville | Tennessee | 37043 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Houston | Texas | 77004 | United States |
| Longview | Texas | 75605 | United States |
| San Antonio | Texas | 78205 | United States |
| San Antonio | Texas | 78229 | United States |
| Lehi | Utah | 84043 | United States |
| Ogden | Utah | 84405 | United States |
| Pleasant Grove | Utah | 84062 | United States |
| Provo | Utah | 84604 | United States |
| South Jordan | Utah | 84095 | United States |
| Springville | Utah | 84663 | United States |
| St. George | Utah | 84790 | United States |
| Urem | Utah | 84057 | United States |
| Charlottesville | Virginia | 22902 | United States |
| Charlottesville | Virginia | 22903 | United States |
| Charlottesville | Virginia | 22911 | United States |
| Midlothian | Virginia | 23113 | United States |
| Richmond | Virginia | 23219 | United States |
| Huntington | West Virginia | 25701 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Marshfield | Wisconsin | 54449 | United States |
| San Juan | PR | 00918 | Puerto Rico |
Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
| FG002 | Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| FG003 | Group 4: MMRV + PCV at 12 Months | Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Menactra® at 9 and 12 Months | Participants who received only Menactra® vaccination at 9 and 12 months of age |
| BG001 | Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months | Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age |
| BG002 | Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months | Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| BG003 | Group 4: MMRV + PCV at 12 Months | Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Days |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) | Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella. | Antibody responses were evaluated in the per-protocol population. | Posted | Number | Percentage of Participants | Day 30 after the 12-month vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 | Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 after the 12-month vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 | Posted | Number | Percentage of Participants | Day 30 after 12-month vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age | Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling. Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability. | Posted | Number | Percentage of Participants | Days 0 to 7 after vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age | Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population. | Posted | Number | Percentage of Participants | Days 0 to 7 after vaccination |
|
Adverse events data were collected for 6 months after the last vaccination.
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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 | Group 1: Menactra® at 9 and 12 Months | Participants who received only Menactra® vaccination at 9 and 12 months of age | 14 | 257 | 91 | 257 | ||
| EG001 | Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month | Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age | 24 | 616 | 185 | 664 | ||
| EG002 | Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months | Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age | 10 | 246 | 77 | 246 | ||
| EG003 | Group 4: MMRV + PCV at 12 Months | Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age | 17 | 476 | 148 | 476 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital spinal cord anomaly | Congenital, familial and genetic disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Infected Cyst | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Kawasaki's diseas | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Periumbilical abscess | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Closed head injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Craniosynostosis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Autism | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Myoclonic epilepsy | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchial hyperactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| D002644 | Chickenpox |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| 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 |
| D016871 | Pasteurellaceae Infections |
Not provided
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| C050102 | measles, mumps, rubella, varicella vaccine |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Rubella |
|
| Varicella |
|
|
|
|
|
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
|
|
|
|