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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_071 |
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Immunogenicity and Safety of V260 in Healthy Infants in Korea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | RotaTeq |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus Vaccine, Live, Oral, Pentavalent | Biological | 3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Anti-Rotavirus IgA Response | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3 | Baseline and 14 days Postdose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3 | Baseline and 14 days Postdose 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18174862 | Result | Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J. 2008 Feb;27(2):177-8. doi: 10.1097/INF.0b013e31815aba79. |
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Subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of
known prior rotavirus disease; ongoing chronic diarrhea or failure to thrive and those with clinical evidence
of active gastrointestinal illness were excluded.
The study was conducted at 8 sites.in Korea from 02-Aug-2005 (first patient in) to 25-May-2006 (last dose
given). Last subject completed follow-up: 05-Jul-2006. All data corrections applied (Frozen File) on 18-
Aug-2006
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| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq™ | Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination. |
| FG001 | Placebo | Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq™ | Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination. |
| BG001 | Placebo |
| 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 | Serum Anti-Rotavirus IgA Response | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3 | Per Protocol Population | Posted | Number | Participants | Baseline and 14 days Postdose 3 |
|
Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment.
Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
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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 | RotaTeq™ | Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute tonsillopharyngitis | Blood and lymphatic system disorders | WHOART92 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Comparator: Placebo | Biological | 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2 |
|
| Withdrawal by Subject |
|
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3 | Per Protocol Population | Posted | Number | Participants | Baseline and 14 days Postdose 3 |
|
|
|
| 6 |
| 114 |
| 110 |
| 114 |
| EG001 | Placebo | Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination. | 7 | 63 | 63 | 63 |
| Acute bronchiolitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | WHOART92 | Non-systematic Assessment |
|
| Acute tonsillopharyngitis mild | Blood and lymphatic system disorders | WHOART92 | Non-systematic Assessment |
|
| Laryngomalacia | Congenital, familial and genetic disorders | WHOART92 | Non-systematic Assessment |
|
| Conjunctival injection | Eye disorders | WHOART92 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | WHOART92 | Non-systematic Assessment |
|
| Eye discharge | Eye disorders | WHOART92 | Non-systematic Assessment |
|
| Eye disorders | Eye disorders | WHOART92 | Non-systematic Assessment |
|
| Strabismus | Eye disorders | WHOART92 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | WHOART92 | Non-systematic Assessment |
|
| Fever | General disorders | WHOART92 | Non-systematic Assessment |
|
| Irritability | General disorders | WHOART92 | Non-systematic Assessment |
|
| Atopy | Immune system disorders | WHOART92 | Non-systematic Assessment |
|
| Acute bronchiolitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Acute pharyngitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Chickenpox | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Cold | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Croup | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Enteritis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Enterovirus infection | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Perianal abscess | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | WHOART92 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | WHOART92 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | WHOART92 | Non-systematic Assessment |
|
| Oral intake reduced | Metabolism and nutrition disorders | WHOART92 | Non-systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Fear | Psychiatric disorders | WHOART92 | Non-systematic Assessment |
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| Food aversion | Psychiatric disorders | WHOART92 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | WHOART92 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | WHOART92 | Non-systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | WHOART92 | Non-systematic Assessment |
|
| Nasal stuffiness | Respiratory, thoracic and mediastinal disorders | WHOART92 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | WHOART92 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Diaper rash | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Facial rash | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | WHOART92 | Non-systematic Assessment |
|
| Vesicle | Skin and subcutaneous tissue disorders | WHOART92 | 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.
| Number of subjects with ≥ 3-fold rise in SNA to G3 |
|
| Number of subjects with ≥ 3-fold rise in SNA to G4 |
|
| Number of subjects with ≥3-fold rise in SNA to P1A |
|