Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006_040 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 µg Modified Process Hepatitis B Vaccine Booster (Group 1) | Active Comparator | Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose). |
|
| 10 µg ENGERIX-B™ Booster (Group 2) | Active Comparator | Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose) |
|
| 5 µg Modified Process Hepatitis B Vaccine Booster (Group 3) | Active Comparator | Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose). |
|
| 10 µg ENGERIX-B™ Booster (Group 4) | Active Comparator | Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Modified Process Hepatitis B Vaccine | Biological | Single dose 5 µg/0.5ml modified process hepatitis B vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy | Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy | Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy | Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HBâ„¢ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-Bâ„¢ | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20724955 | Result | Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To be eligible for enrollment in the study, participants were to have received a primary series of 3 doses of the same type of hepatitis B vaccine (either RECOMBIVAX HB or ENGERIX-B) during the first year of life.
This study was conducted at 77 primary study sites in Spain and 1 study site in Canada.
Date of first subject visit: 26-Sep-2006; Date of last subject visit: 23-June-2008
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Modified Process Hepatitis B Vaccine Booster (Group 1) | Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) |
| FG001 | ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) | Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) |
| FG002 | Modified Process Hepatitis B Vaccine Booster (Group 3) | Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) |
| FG003 | ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) | Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) |
| FG004 | Modified Process Hepatitis B Vaccine (Group 5) | Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Modified Process Hepatitis B Vaccine Booster (Group 1) | Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy | Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. | Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol. | Posted | Number | Participants | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
|
Not provided
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
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 | Modified Process Hepatitis B Vaccine Booster (Group 1) | Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 5 µg Modified Process Hepatitis B Vaccine (Group 5) | Experimental | Participants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine. |
|
| Comparator: Comparator: ENGERIX-B | Biological | Single dose 10 µg/0.5ml ENGERIX-B |
|
| Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy | Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-Bâ„¢ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-Bâ„¢ | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Difficulties in specimen collection |
|
| Vaccine supply issue |
|
| BG001 |
| ENGERIX-Bâ„¢ Booster (RECOMBIVAX-HBâ„¢ in Infancy) (Group 2) |
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) |
| BG002 | Modified Process Hepatitis B Vaccine Booster (Group 3) | Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) |
| BG003 | ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) | Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) |
| BG004 | Modified Process Hepatitis B Vaccine (Group 5) | Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
| OG001 | ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) | Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) |
|
|
|
| Secondary | Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy | Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™. | Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol. | Posted | Number | Participants | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
|
|
|
|
| Other Pre-specified | Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy | Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HBâ„¢ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-Bâ„¢ | Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
|
|
|
| Other Pre-specified | Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy | Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-Bâ„¢ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-Bâ„¢ | Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B |
|
|
|
| 0 |
| 369 |
| 214 |
| 369 |
| EG001 | ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2) | Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) | 0 | 368 | 192 | 368 |
| EG002 | Modified Process Hepatitis B Vaccine Booster (Group 3) | Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose) | 0 | 344 | 198 | 344 |
| EG003 | ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4) | Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose) | 2 | 342 | 194 | 342 |
| EG004 | Modified Process Hepatitis B Vaccine (Group 5) | Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) | 0 | 19 | 9 | 19 |
| Tonsillitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Motion Sickness | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Eye Discharge | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Eye Swelling | Endocrine disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Discomfort | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypothermia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Malaise | 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 |
|
| Vessel puncture site pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Cystitis | 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 |
|
| Fungal infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Laryngitis | 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 |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Scarlet fever | 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 |
|
| Tonsillitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Tonsillitis streptococcal | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Vulvovaginitis | 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 |
|
| Bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Arthralgia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Bone pain | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Epiphysiolysis | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Myalgia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Neck pain | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pain in extremity | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Aphonia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | 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 |
|
| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dermatitis | 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 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Bruising, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Erythema, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hematoma, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypersensitivity, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Induration, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Edema, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pain, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paraesthesia, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Scar, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Swelling, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vesicles, Injection site for hepatitis B vaccine | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Warmth, Injection site for hepatitis B vaccine | 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.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |