E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
RotaTeq® is indicated for the active immunisation of infants from age of 6 weeks for prevention of gastroenteritis due to rotavirus infection.
NeisVac-C® is indicated for active immunisation of children from 2 months of age for the prevention of invasive disease caused by Neisseria meningitidis serogroup C |
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MedDRA Classification |
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 |
To demonstrate that RotaTeq® can be administered concomitantly with MCC vaccine to healthy infants without impairing the antibody seroprotection rate to meningococcal Group C serotype as measured by serum bactericidal antibody with rabbit complement (rSBA) at 28 days following the last dose. |
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E.2.2 | Secondary objectives of the trial |
1. To describe the immunogenicity of RotaTeq® and of the MCC vaccine when administered concomitantly with RotaTeq®.
2. To describe the safety profile of RotaTeq® and of the MCC vaccine when administered concomitantly with RotaTeq®.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy infants, aged from 6 weeks through full 7 weeks (≥ 42 to < 56 days; 6th week birthday to one day prior to the 8th week birthday), 2. Consent form signed by at least one parent or by the legal representative properly informed about the study, 3. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
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E.4 | Principal exclusion criteria |
1. History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery, 2. Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, 3. Known or suspected impairment of immunological function, 4. Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid), 5. Prior administration of any rotavirus vaccine, 6. Prior administration of any vaccine within the 28 days prior to randomisation, 7. Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation, 8. History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive, 9. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, 10. Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease may participate in the study as long as the gastroesophageal reflux disease is well controlled with or without medication, 11. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study, 12. Infants residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalised malignancy, chronic renal failure, meningitis, organ or bone marrow transplantation, or with those receiving anti-cancer drugs or immunosuppressive chemotherapy, including long-term systemic corticosteroids, 13. Prior receipt of a blood transfusion or blood products, including immunoglobulins, 14. Participation in another clinical study before or during the current clinical study, 15. Any infant who cannot be adequately followed for safety by a contact visit, 16. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
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E.5 End points |
E.5.1 | Primary end point(s) |
Men C seroprotection rate (i.e. the proportion of subjects who achieve a Men C-rSBA titre >= 1:8) as measured 28 days following the 2nd MCC vaccine dose, in the concomitant administration group is non-inferior to that in the separate administration group. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 7 |