E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1 (e.g., G9). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 10 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017913 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective : (1) To evaluate the immunogenicity of intramuscular INFANRIX™ hexa (in relation to serum anti-polyribosylribitol phosphate [PRP] and anti-hepatitis B surface antigen [HBsAg]) when administered concomitantly with RotaTeq™†; (2) To assess the safety of RotaTeq™ when administered concomitantly with intramuscular INFANRIX™ hexa. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives : (1) To evaluate the immunogenicity of RotaTeq™ (as measured by serum anti-rotavirus IgA and serum neutralizing antibody [SNA] responses to rotavirus serotypes G1, G2, G3, G4, and P1A) when administered concomitantly with intramuscular INFANRIX™ hexa; (2) To evaluate the immunogenicity of intramuscular INFANRIX™ hexa (in relation to serum antibody levels to Diphtheria toxoid, Tetanus toxoid, Pertussis toxoid [PTxd], Pertussis filamentous hemagglutinin [FHA], Pertussis pertactin [PRN], and poliovirus types 1, 2, and 3) when administered concomitantly with RotaTeq™. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Infants in good health, 6 to 12 weeks of age. |
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E.4 | Principal exclusion criteria |
History of congenital abdominal disorders, intussusception, or abdominal surgery. Known or suspected impairment of immunological function. Known hypersensitivity to any component of the rotavirus vaccine. Prior administration of any rotavirus vaccine. Known hypersensitivity or contraindication to any component of the INFANRIX™ hexa vaccine. Any infant born from a known HBsAg-positive mother. Prior administration of any oral polio vaccine. Receipt of one or more doses of inactivated poliovirus vaccine, diphtheria, tetanus and acellular pertussis vaccine, diphtheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination. Fever, with a rectal temperature greater than/equal to 38.1 degrees C (great than/equal to 100.5 degrees F) at the time of immunization. History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive. Clinical evidence of active gastrointestinal illness. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. Infants residing in a household with an immunocompromised person. Prior receipt of a blood transfusion or blood products. History of seizure disorders or prior history of seizure disorders with or without fever. |
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E.5 End points |
E.5.1 | Primary end point(s) |
(1) The seroprotection rate for polyribosylribitol phosphate (PRP), the proportion of subjects who achieve serum antibody levels of ≥0.15 µg/mL, as measured post dose 3, in subjects receiving RotaTeq™ concomitantly with INFANRIX™ hexa is non-inferior to those in subjects receiving placebo concomitantly with INFANRIX™ hexa [Non-inferiority criterion corresponds to the lower bound of the two-sided 95% confidence interval on the difference in proportion, excluding a decrease of ≥10 percentage points].
(2) The seroprotection rate for hepatitis B surface antigen (HBsAg), the proportion of subjects who achieve serum antibody levels ≥10 mIU/mL, as measured post dose 3, in subjects receiving RotaTeq™ concomitantly with INFANRIX™ hexa is non-inferior to those in subjects receiving placebo concomitantly with INFANRIX™ hexa [Non-inferiority criterion corresponds to the lower bound of the two-sided 95% confidence interval on the difference in proportion+, excluding a decrease of ≥10 percentage points].
(3) RotaTeq™ is generally well tolerated when administered concomitantly with INFANRIX™ hexa.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The duration of the study will be from the time the first subject is enrolled until after the last subject is enrolled, and has had his/her 42-day blood draw after the third dose of RotaTeq™/placebo and INFANRIX™ hexa. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |