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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_077 |
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This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
The duration of treatment is 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | Experimental | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart. |
|
| Placebo matching RotaTeqâ„¢ | Placebo Comparator | Placebo matching RotaTeqâ„¢ administered 28 to 70 days apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RotaTeqâ„¢, rotavirus vaccine, live, oral, pentavalent | Biological | Three doses of RotaTeqâ„¢ administered 28 to 70 days apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition | At least 14 days following the 3rd vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer) | 14 days following the 3rd vaccination |
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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 |
|---|---|---|---|
| 17200266 | Background | Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM; Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007 Jan;119(1):11-8. doi: 10.1542/peds.2006-2058. |
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Excluded from the trial before assignment to groups were patients with: history of congenital abdominal
disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea,
or failure to thrive.
The study was conducted at 30 sites - 27 in the United States, and 3 in Finland from 24-Sep-2002 (first
patient in) to 11-Feb-2004 (last dose given).
Last subject completed follow-up: 08-Jun-2004.
All data corrections applied (Frozen File): 07-Sep-2004
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| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | Three 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, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination. |
| FG001 | Placebo Matching RotaTeqâ„¢ | Placebo matching RotaTeqâ„¢ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | Three 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, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination. |
| BG001 |
| 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 | Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition | Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen Enzyme immunoassay (EIA) prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. | Posted | Number | Participants | At least 14 days following the 3rd 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 | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | Three 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, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 8.0 | Systematic Assessment |
Safety has been reported in the literature.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C492535 | RotaTeq |
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Comparator: Placebo matching RotaTeqâ„¢ | Biological | Placebo matching RotaTeqâ„¢ administered 28 to 70 days apart. |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Moved |
|
| Other |
|
| Placebo Matching RotaTeqâ„¢ |
Placebo matching RotaTeqâ„¢ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity | Number | participants |
|
| OG001 | Placebo Matching RotaTeqâ„¢ | Placebo matching RotaTeqâ„¢ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination. |
|
|
|
| Secondary | Number of Subjects With ≥3 Fold Rise in Antibody Titer | Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer) | Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen EIA prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. | Posted | Number | Participants | 14 days following the 3rd vaccination |
|
|
|
|
| 21 |
| 649 |
| 558 |
| 649 |
| EG001 | Placebo Matching RotaTeqâ„¢ | Placebo matching RotaTeqâ„¢ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination. | 28 | 658 | 565 | 658 |
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Perirectal abscess | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Sudden infant death syndrome | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Milk allergy | Immune system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Cerebral cyst | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Regurgitation of food | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | 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.
| 2.7 |
| 95 |
| 0.3 |
| 9.5 |
| No |
| Superiority or Other |
| Percent of Participants | 14.5 | 95 | 6.9 | 25.8 | No | Superiority or Other |
| Percent of Participants | 0.0 | 95 | 0.0 | 5.1 | No | Superiority or Other |
| Percent of Participants | 9.0 | 95 | 3.4 | 18.5 | No | Superiority or Other |
| Percent of Participants | 0.0 | 95 | 0.0 | 4.8 | No | Superiority or Other |
| Percent of Participants | 39.7 | 95 | 27.6 | 52.8 | No | Superiority or Other |
| Percent of Participants | 1.4 | 95 | 0.0 | 7.7 | No | Superiority or Other |
| Percent of Participants | 24.6 | 95 | 14.5 | 37.3 | No | Superiority or Other |
| Percent of Participants | 2.9 | 95 | 0.4 | 10.1 | No | Superiority or Other |