Primary Outcome Measures:
- Occurrence, intensity and relationship to re-vaccination of solicited local and general signs and symptoms. [ Time Frame: During a 7-day follow-up period after re-vaccination in each group. ] [ Designated as safety issue: Yes ]
- Occurrence, intensity and relationship to re-vaccination of unsolicited adverse events (AEs) [ Time Frame: During a 30-day follow-up period after re-vaccination in each group ] [ Designated as safety issue: Yes ]
- Occurrence and relationship to re-vaccination of serious adverse events [ Time Frame: During the entire study period in each group. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine influenza virus strains, in each group [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
- For each vaccine strain, geometric mean titre (GMT) of serum HI antibody [ Time Frame: At Days 0 and 21. ] [ Designated as safety issue: No ]
- For each vaccine strain, seroconversion rate [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
- For each vaccine strain, seroprotection rate [ Time Frame: At Day 0 and 21 ] [ Designated as safety issue: No ]
- For each vaccine strain, seroconversion factor [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.