Phase 3
Completed N=1,522
Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup
Source: ClinicalTrials.gov NCT00579345 ↗Enrolled (actual)
1,522
Serious AEs
4.3%
Results posted
Oct 2011
Primary outcomePrimary: Number of Randomized Participants Reporting Local and Systemic Reactions. — 52; 37; 24; 19 Subjects
Summary
The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV\_a in adults and elderly subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Randomized Participants Reporting Local and Systemic Reactions. |
52; 37; 24; 19; 15; 8 | — |
| PRIMARY Immunogenicity Assessment by Geometric Mean Titers (GMT). |
138; 198; 184; 228; 36; 52 | — |
| SECONDARY Number of Unrandomized Participants Reporting Local and Systemic Reactions. |
185; 60; 98; 26; 50; 20 | — |
| SECONDARY Number of Randomized Participants Reporting Local and Systemic Reactions. |
52; 37; 24; 19; 15; 8 | — |
| SECONDARY Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. |
94; 23; 85; 55; 57; 13 | — |
| SECONDARY Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. |
5.6; 4.38; 7.75; 5.92; 3.63; 2.33 | — |
Eligibility Criteria
Inclusion Criteria
- participation in the V58P4 study
- mentally competent to understand the nature, the scope and the consequences of the study
- able and willing to give written informed consent prior to study entry
- available for all the visits scheduled in the study
Exclusion Criteria
- receipt of another investigational agent within 90 days prior to, or before completion of the safety follow-up period in another study, whichever is longer, prior to Visit 7 and unwilling to refuse participation in another clinical study through the end of the present study
- history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine components
- any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever (i.e., axillary temperature ≥ 38°C) within the 5 days prior to Visit 7
- pregnant/breast feeding women, or women of childbearing potential who refuse to use a reliable contraceptive method during the three weeks after vaccination
Data sourced from ClinicalTrials.gov (NCT00579345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.