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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_046 |
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The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | RotaTeq/Infanrix Hexa |
|
| 2 | Placebo Comparator | Placebo/Infanrix Hexa |
|
| 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 42 days post dose 1 and 28 to 42 days post dose 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1 | Geometric Mean Titer (GMT)/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen | Day 1 of a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen | GMT/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen | 42 days after 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1 | GMT/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen | Day 1 of 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen | GMT/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
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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 |
|---|---|---|---|
| 19209092 | Result | Ciarlet M, He S, Lai S, Petrecz M, Yuan G, Liu GF, Mikviman E, Heaton PM, Panzer F, Rose T, Koller DY, Van Damme P, Schodel F. Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. Pediatr Infect Dis J. 2009 Mar;28(3):177-81. doi: 10.1097/INF.0b013e31818c0161. |
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Excluded from randomization were patients 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 26 sites in Austria, Belgium, and Germany from 22Feb2006 (first subject in) to 13Nov2006 (last subject out). Cutoff date for all clinical and laboratory data from the Case Report Forms in-house was 08Jun2007. Access to the clinical database was granted on 15Jun2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq™ + INFANRIX Hexa | Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart. |
| FG001 | Placebo + INFANRIX Hexa | For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIXâ„¢ hexa at intervals of 4 to 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq™ + INFANRIX Hexa | Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart. |
| BG001 | Placebo + INFANRIX Hexa | For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIXâ„¢ hexa at intervals of 4 to 6 weeks. |
| 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 | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1 | Geometric Mean Titer (GMT)/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen | All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Day 1 of a 3-dose regimen |
|
Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables 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™ + INFANRIX Hexa | Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal symptom | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| 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 |
|---|---|
| D022243 | Rotavirus Vaccines |
| D000118 | Acetylglucosaminidase |
| 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 42 days post dose 1 and 28 to 42 days post dose 2 |
|
| Comparator: Infanrix(tm) Hexa | Biological | 3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2 |
|
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa , 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Pre-dose (Day 1 of a 3-dose regimen) |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after in a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of pertussis FHA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of pertussis FHA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of pertussis Pertactin in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of pertussis Pertactin in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of pertussis toxoid in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of pertussis toxoid in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa, Predose 1 | GMT of serotype G1 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa, 42 Days After a 3-dose Regimen | GMT of serotype G1 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa, Predose 1 | GMT of serotype G2 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Predose (Day 1 of a 3-dose regimen) |
| Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype G2 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serotype G3 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) |
| Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype G3 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serotype G4 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) |
| Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype G4 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serotype P1A in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) |
| Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype P1A in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serum anti-rotavirus IgA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) |
| Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serum anti-rotavirus IgA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | 42 days after a 3-dose regimen |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Moved |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG001 |
| Placebo + INFANRIX Hexa |
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIXâ„¢ hexa at intervals of 4 to 6 weeks. |
|
|
| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis on Subset A (subjects with even allocation numbers) | Posted | Geometric Mean | 95% Confidence Interval | Dilution Unit | Predose (Day 1 of a 3-dose regimen) |
|
|
|
| Primary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen | GMT/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen | All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 42 days after 3-dose regimen |
|
|
|
|
| Primary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1 | GMT/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen | All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Day 1 of 3-dose regimen |
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| Primary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen | GMT/antibody responses to RotaTeqâ„¢ and INFANRIXâ„¢ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen | All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 42 days after a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa , 42 days after a 3-dose regimen | Per Protocol Analysis on Subset A (subjects with even allocation numbers) | Posted | Geometric Mean | 95% Confidence Interval | Dilution Unit | 42 days after a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis on Subset A (subjects with even allocation numbers) | Posted | Geometric Mean | 95% Confidence Interval | Dilution Unit | Pre-dose (Day 1 of a 3-dose regimen) |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis on Subset A (subjects with even allocation numbers) | Posted | Geometric Mean | 95% Confidence Interval | Dilution Unit | 42 days after in a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis on Subset A (subjects with even allocation numbers) | Posted | Geometric Mean | 95% Confidence Interval | Dilution Unit | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis on Subset A (subjects with even allocation numbers) | Posted | Geometric Mean | 95% Confidence Interval | Dilution Unit | 42 days after a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis on Subset B (subjects with odd allocation number) | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis on Subset B (subjects with odd allocation number) | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 42 days after a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis on Subset B (subjects with odd allocation numbers) | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis on Subset B (subjects with odd allocation numbers | Posted | Geometric Mean | 95% Confidence Interval | Dilution Unit | 42 days after a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of pertussis FHA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of pertussis FHA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Least Squares Mean | 95% Confidence Interval | EU/mL | 42 days after a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of pertussis Pertactin in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of pertussis Pertactin in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 42 days after a 3-dose regimen |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeqâ„¢, Predose 1 | GMT of pertussis toxoid in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Immunogenicity of INFANRIXâ„¢ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeqâ„¢, 42 Days After a 3-dose Regimen | GMT of pertussis toxoid in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 42 days after a 3-dose regimen |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa, Predose 1 | GMT of serotype G1 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa, 42 Days After a 3-dose Regimen | GMT of serotype G1 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | 42 days after a 3-dose regimen |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa, Predose 1 | GMT of serotype G2 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa at the start of a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype G2 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | 42 days after a 3-dose regimen |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serotype G3 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype G3 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | 42 days after a 3-dose regimen |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serotype G4 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype G4 in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | 42 days after a 3-dose regimen |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serotype P1A in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serotype P1A in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | 42 days after a 3-dose regimen |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa Predose 1 | GMT of serum anti-rotavirus IgA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa Predose 1 | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | Predose (Day 1 of a 3-dose regimen) |
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| Secondary | Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeqâ„¢ Concomitantly With INFANRIXâ„¢ Hexa 42 Days After a 3-dose Regimen | GMT of serum anti-rotavirus IgA in subjects receiving RotaTeqâ„¢ + INFANRIXâ„¢ hexa compared to those receiving placebo + INFANRIXâ„¢ hexa 42 days after a 3-dose regimen | Per Protocol Analysis | Posted | Geometric Mean | 95% Confidence Interval | GMT | 42 days after a 3-dose regimen |
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|
| 3 |
| 201 |
| 166 |
| 201 |
| EG001 | Placebo + INFANRIX Hexa | For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIXâ„¢ hexa at intervals of 4 to 6 weeks. | 6 | 202 | 167 | 202 |
| Enteritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | 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.
| D001619 |
| beta-N-Acetylhexosaminidases |
| D006596 | Hexosaminidases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |