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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_030 |
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The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | RotaTeq and OPV concomitantly |
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| 2 | Experimental | RotaTeq and OPV on staggered schedule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus Vaccine, Live, Oral, Pentavalent | Biological | Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 | GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered. | Approximately 42 days Postdose 3 |
| GMT of Serum Anti-rotavirus Immunoglobulin A (IgA) | GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered | Approximately 42 days Postdose 3 |
| Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered | Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered. | Approximately 42 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 |
|---|---|---|---|
| 18756184 | Result | Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schodel F. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008 Oct;27(10):874-80. doi: 10.1097/INF.0b013e3181782780. |
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Excluded from randomization were subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive, clinical evidence of active gastrointestinal illness and those with fever, a rectal temperature ≥38.1°C (≥100.5°F) at time of immunization.
Enrollment occurred at 9 study sites in Mexico, Costa Rica, Guatemala, and Brazil from 19-Oct-2005 (first subject in) to 06-Jan-2006 (last subject randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq and Oral Poliovirus (OPV) Concomitantly | Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart |
| FG001 | RotaTeq and Oral Poliovirus (OPV) Staggered |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Oral Poliovirus Vaccine (OPV) | Biological | Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2. |
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| Comparator: Oral Poliovirus Vaccine (OPV) (staggered) | Biological | Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq. |
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Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq and Oral Poliovirus (OPV) Concomitantly | Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart |
| BG001 | RotaTeq and Oral Poliovirus (OPV) Staggered | Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 | GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered. | The primary immunogenicity analyses were based on evaluable per-protocol subjects who received all scheduled doses, were not protocol violators, and had valid assay values. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titer (GMT) | Approximately 42 days Postdose 3 |
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| Primary | GMT of Serum Anti-rotavirus Immunoglobulin A (IgA) | GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered | Per Protocol Population | Posted | Geometric Mean | 95% Confidence Interval | GMT | Approximately 42 days Postdose 3 |
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| Primary | Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered | Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered. | Per Protocol Population For serotype G4 the RotaTeq and Oral Poliovirus (OPV) concomitantly group N = 350 | Posted | Geometric Mean | 95% Confidence Interval | GMT | Approximately 42 days Postdose 3 |
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Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment.
Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject 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 and Oral Poliovirus (OPV) Concomitantly | Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart | 4 | 366 | 342 | 366 | ||
| EG001 | RotaTeq and Oral Poliovirus (OPV) Staggered | Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later | 9 | 359 | 325 | 359 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intussusception | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Meningitis pneumococcal | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Pertussis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Infantile colic | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Crying | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D023321 | Poliovirus Vaccines |
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| Over 12 Weeks of Age |
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| Male |
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| Black |
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| Hispanic American |
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| Multi-Racial |
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| White |
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| Antibody Responses to Poliovirus Type 3 |
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| Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers [NA] ≥1:8) for poliovirus type 2 | Miettinen and Nurminen's | Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method. | <0.001 | Seroprotection Rate Difference | 0.0 | 95 | -1.4 | 1.6 | Yes | Non-Inferiority or Equivalence | non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers [NA] ≥1:8 greater than -10%. |
| Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers [NA] ≥1:8) for poliovirus type 3 | Miettinen and Nurminen's | Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method. | <0.001 | Seroprotection Rate Difference | -0.1 | 95 | -2.3 | 2.3 | Yes | Non-Inferiority or Equivalence | non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers [NA] ≥1:8 greater than -10%. |
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