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Also known as 1. Menjugate, 2. Encepur Children
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...
It is an investigational influenza vaccine developed by Novartis AG (ticker NVS). The Phase 3 study evaluated its efficacy, safety, and immunogenicity in healthy subjects aged 6 to under 72 months, compared with control vaccines. The trial enrolled 4,902 participants across Finland, Germany, and Italy and has been completed.
It is being studied for the prevention of influenza in humans, specifically in young children. The Phase 3 trial NCT00644059 assessed the vaccine in healthy subjects aged 6 months to under 72 months. The indication listed for the program is Influenza, Human, within the infectious disease therapeutic area.
Novartis AG, which trades under the ticker NVS, is the developer of this influenza vaccine candidate. The company sponsored the Phase 3 study NCT00644059, titled a study to evaluate the efficacy, safety and immunogenicity of influenza vaccine in healthy subjects aged 6 to under 72 months versus control vaccines.
It is in Phase 3 development. One Phase 3 trial, NCT00644059, has been completed, and no trials for this program are currently listed as active. The study was randomized and actively controlled, with 4,902 participants enrolled. It is an investigational vaccine and is not described as approved.
The program includes the completed Phase 3 trial NCT00644059, a study to evaluate the efficacy, safety and immunogenicity of influenza vaccine in healthy subjects aged 6 to under 72 months versus control vaccines. It enrolled 4,902 healthy volunteers of all sexes in Finland, Germany, and Italy, and used an active-controlled, randomized design.
No. The candidate studied in NCT00644059 is an influenza vaccine for the indication Influenza, Human. Meningococcal C conjugate and tick-borne encephalitis vaccines are separate products directed at different diseases. The Novartis program described here is specific to influenza prevention in young children.