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Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine · 1 trial · 1 indication
Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.
Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to \<36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.
| Arm | Type | Description |
|---|---|---|
| TIV-adj | EXPERIMENTAL | Adjuvanted trivalent inactivated subunit influenza vaccine |
| Flu-control | ACTIVE_COMPARATOR | Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine |
| Non-flu Control | SHAM_COMPARATOR | Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine |
| Name | Type | Description |
|---|---|---|
| Adjuvanted trivalent inactivated subunit influenza vaccine | BIOLOGICAL | Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm. |
| Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine | BIOLOGICAL | For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm. |
| Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine | BIOLOGICAL | 1. Meningococcal vaccine: two IM injections 2. Tick-borne encephalitis vaccine: two IM injections |
Inclusion Criteria: * Children whose parents/legal guardians have given written informed consent prior to study entry: a) aged 6 to \<72 months (Part I and II of the study; influenza seasons 2007/2008 and 2008/2009) b) aged 6 to \<36 months (Part III of the study; influenza season 2009/2010) * In g...