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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_020 |
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To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | Experimental | Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus Vaccine, Live, Oral, Pentavalent | Biological | Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA | Baseline and Approximately 6 Months | |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA) | Baseline and Approximately 6 Months | |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months | |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months | |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months | |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months | |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months | |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA |
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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 |
|---|---|---|---|
| 23442588 | Derived | Lokeshwar MR, Bhave S, Gupta A, Goyal VK, Walia A. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Hum Vaccin Immunother. 2013 Jan;9(1):172-6. doi: 10.4161/hv.22341. |
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Open-label, single-arm study. Healthy infants between the ages of 6 weeks through exactly 12 weeks (≥42 to ≤84 days) at entry who did not have clinical evidence of active gastrointestinal illness; who did not have fever, with a rectal temperature of greater than and equal to 38 degrees Celsius at first vaccination were enrolled in the study.
Phase III
First Patient In (FPI): 09-May-2008
Last Patient Out (LPO): 20-Nov-2008
Multi-center study
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| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq™ Vaccine (V260) | Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq™ Vaccine (V260) | Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart. |
| 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 | The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™
Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose
6 subjects did not report after dose 1 and were considered lost to follow-up
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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™ Vaccine (V260) | Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
|
| Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | Baseline and Approximately 6 Months |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Temperature | Mean | Standard Deviation | Fahrenheit |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
|
| Primary | The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results. | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA) | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Number | Percentage of Participants | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| Primary | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and Approximately 6 Months |
|
|
|
| 1 |
| 104 |
| 47 |
| 104 |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Irritability | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal 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.