Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006_027 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | RotaTeq™ |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent | Biological | 2.0 mL oral dose of RotaTeq™. 14 week treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose | At least 14 days following the third vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer) | 14 days following the 3rd vaccination |
| Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] |
Not provided
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 |
|---|---|---|---|
| 29564996 | Derived | Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk M. Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries. Epidemiol Infect. 2018 Apr;146(6):698-704. doi: 10.1017/S0950268818000626. Epub 2018 Mar 22. | |
| 27755463 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Excluded from the trial before assignment to groups were subjects: with history of active gastrointestinal illness (vomiting, diarrhea, elevated temperature); who were participating in (or expected to participate in) other investigational-product studies; who could not be followed adequately for safety.
The study was conducted at 5 international sites - Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given).
Last subject completed follow-up: 31 March 2009
All data corrections applied (Frozen File): 20 July 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq™ - Africa | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| FG001 | Placebo - Africa | Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| FG002 | RotaTeq™ - Asia | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| FG003 | Placebo - Asia | Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq™ - Africa | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| BG001 | Placebo - Africa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose | Per Protocol Population | Posted | Number | Subjects | At least 14 days following the third vaccination |
|
Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination.
For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
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 | RotaTeq™ | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia). Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D003967 | Diarrhea |
| D005334 | Fever |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
Not provided
Not provided
| ID | Term |
|---|---|
| C492535 | RotaTeq |
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: Placebo | Biological | Arm 2: Placebo. 14 week treatment period |
|
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer) |
| 14 days following the 3rd vaccination |
| Gruber JF, Hille DA, Liu GF, Kaplan SS, Nelson M, Goveia MG, Mast TC. Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries. Pediatr Infect Dis J. 2017 Jan;36(1):72-78. doi: 10.1097/INF.0000000000001362. |
| 20692031 | Derived | Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schodel F, Steele AD, Neuzil KM, Ciarlet M. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):615-23. doi: 10.1016/S0140-6736(10)60755-6. Epub 2010 Aug 6. |
| 20692030 | Derived | Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schodel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):606-14. doi: 10.1016/S0140-6736(10)60889-6. Epub 2010 Aug 6. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| BG002 | RotaTeq™ - Asia | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| BG003 | Placebo - Asia | Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 | RotaTeq™ - Asia | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
| OG003 | Placebo - Asia | Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. |
|
|
|
| Secondary | Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer) | Per Protocol Population *N analyzed for Serotype P1A[8] is 188 | Posted | Number | Subjects | 14 days following the 3rd vaccination |
|
|
|
|
| Secondary | Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer) | Per Protocol Population | Posted | Number | Subjects | 14 days following the 3rd vaccination |
|
|
|
|
| 144 |
| 3,744 |
| 0 |
| 0 |
| EG001 | Placebo | Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia). Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination. | 156 | 3,745 | 0 | 0 |
| EG002 | RotaTeq™, Placebo, RotaTeq™ | Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination. | 1 | 3 | 0 | 0 |
| EG003 | Placebo, Placebo, RotaTeq™ | Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination. | 0 | 1 | 0 | 0 |
| EG004 | RotaTeq™ - Kenya Safety Cohort | A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination. | 0 | 0 | 137 | 149 |
| EG005 | Placebo - Kenya Safety Cohort | A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination. | 0 | 0 | 147 | 152 |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA | Systematic Assessment | Vietnam had 1 confirmed case of intussusception (placebo recipient) subject was treated & fully recovered. The reporting investigator determined the serious event of clinical interest, was of moderate intensity, & not related to the study vaccine. |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Death | General disorders | MedDRA | Systematic Assessment |
|
| Drowning | General disorders | MedDRA | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Sudden infant death syndrome | General disorders | MedDRA | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cerebral malaria | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| HIV infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Meningitis pneumococcal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Omphalitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Snake bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Feeding disorder of infancy or early childhood | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hepatoblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abscess of eyelid | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic rash | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tinea capitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Umbilical sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Feeding disorder of infancy or early childhood | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Crying | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Fontanelle bulging | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pemphigus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pityriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | 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.
| ≥ 3 fold rise in antibody titer: Serotype G2 |
|
| ≥ 3 fold rise in antibody titer: Serotype G3 |
|
| ≥ 3 fold rise in antibody titer: Serotype G4 |
|
| ≥ 3 fold rise in antibody titer: Serotype P1A[8] |
|
| Percentage |
| 18.5 |
| 95 |
| 13.3 |
| 24.8 |
| Superiority or Other |
| Serotype G2 | Percentage | 9.0 | 95 | 5.3 | 14.0 | Superiority or Other |
| Serotype G3 | Percentage | 6.3 | 95 | 3.3 | 10.8 | Superiority or Other |
| Serotype G4 | Percentage | 26.5 | 95 | 20.3 | 33.3 | Superiority or Other |
| Serotype P1A[8] | Percentage | 14.4 | 95 | 9.7 | 20.2 | Superiority or Other |
| Anti-rotavirus IgA | Percentage | 20.1 | 95 | 14.4 | 27.0 | Superiority or Other |
| Serotype G1 | Percentage | 0.0 | 95 | 0.0 | 2.2 | Superiority or Other |
| Serotype G2 | Percentage | 3.0 | 95 | 1.0 | 6.8 | Superiority or Other |
| Serotype G3 | Percentage | 2.4 | 95 | 0.6 | 5.9 | Superiority or Other |
| Serotype G4 | Percentage | 2.4 | 95 | 0.6 | 5.9 | Superiority or Other |
| Serotype P1A[8] | Percentage | 4.7 | 95 | 2.1 | 9.1 | Superiority or Other |
| ≥ 3 fold rise in antibody titer: Serotype G2 |
|
| ≥ 3 fold rise in antibody titer: Serotype G3 |
|
| ≥ 3 fold rise in antibody titer: Serotype G4 |
|
| ≥ 3 fold rise in antibody titer: Serotype P1A[8] |
|
| Percentage |
| 32.1 |
| 95 |
| 24.2 |
| 40.8 |
| Superiority or Other |
| Serotype G2 | Percentage | 9.9 | 95 | 5.4 | 16.4 | Superiority or Other |
| Serotype G3 | Percentage | 28.2 | 95 | 20.7 | 36.8 | Superiority or Other |
| Serotype G4 | Percentage | 18.3 | 95 | 12.1 | 26.0 | Superiority or Other |
| Serotype P1A[8] | Percentage | 27.5 | 95 | 20.0 | 36.0 | Superiority or Other |
| Anti-rotavirus IgA | Percentage | 18.2 | 95 | 12.0 | 25.8 | Superiority or Other |
| Serotype G1 | Percentage | 2.3 | 95 | 0.5 | 6.5 | Superiority or Other |
| Serotype G2 | Percentage | 0.8 | 95 | 0.0 | 4.1 | Superiority or Other |
| Serotype G3 | Percentage | 3.0 | 95 | 0.8 | 7.6 | Superiority or Other |
| Serotype G4 | Percentage | 0.0 | 95 | 0.0 | 2.8 | Superiority or Other |
| Serotype P1A[8] | Percentage | 5.3 | 95 | 2.2 | 10.6 | Superiority or Other |