E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Test subjects are healthy. |
Tutkittavat ovat terveitä. |
|
E.1.1.1 | Medical condition in easily understood language |
Test subjects are healthy. |
Tutkittavat ovat terveitä |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 |
Main goal is to find out the immune response created by RotaTeq vaccine after each dose and its relation to shedding of vaccine derived viruses. |
Tarkoituksena on selvittää RotaTeq® rokotteen aikaansaamaa immuunivastetta elimistössä kunkin rokoteannoksen jälkeen ja sen suhdetta rokotevirusten erittymiseen ulosteisiin.
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E.2.2 | Secondary objectives of the trial |
To study the rotavirus antigen levels after each dose of the vaccine. |
Selvittää rotavirus vasta-ainetaso kunkin rokoteannoksen jälkeen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All healthy six week old children who are born in Turku. |
Terveet 6 viikkoiset Turussa syntyneet lapset. |
|
E.4 | Principal exclusion criteria |
- The subject has or is under suspect of immunological disorder or congenital/acquired state of immune deficiency (e.g. HIV, splenomagaly). - Child is treated with immunosuppressants. - Known or suspected allergy or previous serious allergic reaction caused by some ingridient of RotaTeq vaccine. - Chronic illness, which might interfere taking part to this study. - Child has reveiced blood transfusion or blood products including immunoglobulins. - Child has already had rotavirus infection. - Previous invagination. - Congenital malformation of GI tract. - Child is born before week 32 of pregnancy. - Congenital hearth defect.
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-Tutkittavalla on/epäillään olevan jokin immunologinen häiriö tai synnynnäinen/hankittu immuunipuutostila (esim. HIV, splenomegalia) - Lapselle annetaan immunosuppressiivista hoitoa - Lapsella on tiedetty tai epäilty yliherkkyys tai aiempi vakava allerginen reaktio jollekin rokotteen ainesosista - Krooninen sairaus, joka saattaa häiritä tutkimukseen osallistumista - On saanut verituotteita tai verensiirron, mukaan lukien immunoglobuliinit - Lapsi sairastanut rotavirusinfektion - Aiemmin todettu suolentuppeuma - Synnynnäinen ruoansulatuskanavan epämuodostuma - Syntynyt ennen raskausviikkoa 32 - Synnynnäinen sydänvika |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Shedding of RotaTeq vaccine in stools after each vaccination dose results in lower IgA levels in serum. -Shedding of RotaTeq vaccine strains is more common after the first dose than after second or third immunization.
|
-RotaTeq rokotevirusten erittyminen ulosteisiin rokoteannosten jälkeen havaitaan matalempina serumin IgA tasoina. -Rokote virusten erittyminen on yleisempää ensimmäisen kuin toisen tai kolmannen annoksen jälkeen. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During winter 2015-16. |
Talven 2015-16 aikana |
|
E.5.2 | Secondary end point(s) |
-Prolonged shedding of RotaTeq results to formation of vaccine derived double reassortants -Family members with gastroenteritis symptoms of recently vaccinated children are more often infected by vaccine originated rotaviruses. |
-Pitkittynyt rokotevirusten erittyminen johtaa ns. tupla reassortantti virusten muodostumiseen. -Hiljattain rokotettujen gastroenteriittiin sairastuneilla perheenjäsenillä havaitaan rokotevirusta muita taudinaiheuttajia yleisemmin. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During winter 2015-16. |
Talven 2015-16 aikana |
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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 | Yes |
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 | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |