Table 2.
| Table 2a. Adverse events within 28 days of vaccination: LAIV vs TIV | ||||||||
|---|---|---|---|---|---|---|---|---|
| Group1 | Group2 | Group3 | All Groups | |||||
| Adverse Events1,2 | LAIV | TIV | LAIV | TIV | LAIV | TIV | LAIV | TIV |
| Abdominal Signs & Symptoms | 8 (18%) | 4 (9%) | 7 (14%) | 4 (8%) | 4 (15%) | 2 (7%) | 19 (16%) | 10 (8%) |
| Constitutional Signs & Symptoms | 15 (33%) | 13 (30%) | 13 (26%) | 16 (33%) | 7 (26%) | 4 (14%) | 35 (29%) | 33 (27%) |
| Ear or Eye Signs & Symptoms | 5 (11%) | 2 (5%) | 4 (8%) | 2 (4%) | 0 (0%) | 0 (0%) | 9 (7%) | 4 (3%) |
| Injection Local Reaction | 0 (0%) | 9 (20%) | 0 (0%) | 13 (27%) | 0 (0%) | 6 (21%) | 0 (0%) | 28 (23%) |
| Nasopharyngeal | 28 (62%) | 15 (34%) | 26 (52%) | 15 (31%) | 10 (37%) | 8 (28%) | 64 (52%) | 38 (31%) |
| Other | 3 (7%) | 1 (2%) | 5 (10%) | 1 (2%) | 3 (11%) | 0 (0%) | 11 (9%) | 2 (2%) |
| Pulmonary Signs & Symptoms | 19 (42%) | 13 (30%) | 12 (24%) | 11 (23%) | 8 (30%) | 7 (24%) | 39 (32%) | 31 (26%) |
| Skin Abnormality | 3 (7%) | 0 (0%) | 5 (10%) | 2 (4%) | 2 (7%) | 3 (10%) | 10 (8%) | 5 (4%) |
| Total Subjects | 45 | 44 | 50 | 48 | 27 | 29 | 122 | 121 |
| Table 2b. Toxicity Grades for adverse events within 28 days of vaccination LAIV vs TIV | ||||||||
|---|---|---|---|---|---|---|---|---|
| Group1 | Group2 | Group3 | All Groups | |||||
| Adverse Events1,2 | LAIV | TIV | LAIV | TIV | LAIV | TIV | LAIV | TIV |
| Grade 1 | 22 (49%) | 16 (36%) | 24 (48%) | 14 (29%) | 14 (52%) | 10 (34%) | 60 (49%) | 40 (33%) |
| Grade 2 | 10 (22%) | 8 (18%) | 8 (16%) | 15 (31%) | 5 (19%) | 6 (21%) | 23 (19%) | 29 (24%) |
| Grade 3 3,4 | 2 (4%) | 2 (5%) | 1 (2%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (2%) | 2 (2%) |
| Ungraded Diagnoses5 | 9 [3] | 6 [3] | 8 [2] | 3 [1] | 3 [2] | 3 [1] | 20 [7] | 12 [5] |
| Total Subjects | 45 | 44 | 50 | 48 | 27 | 29 | 122 | 121 |
All adverse events were counted per subject.
Examples of adverse event categories are: abdominal = diarrhea, emesis, pain; constitutional = fever, chills, headache, malaise, fatigue, anorexia; ear or eye = conjunctivitis, ear pain, otitis media; injection site = tenderness, erythema, swelling; nasopharyngeal = discharge, congestion, sore throat; other = lymphadenitis, epistaxis, other viral illnesses; pulmonary = cough, chest pain, pneumonia, asthma; skin = rash, folliculitis, boil, cellulitis.
Worst grade counted per subject. Parentheses indicate per cent of subjects with events of the grade indicated.
Grade from DAIDS Toxicity Manual
Grade 3 Events after LAIV were malaise; finger pain; and leg boil.
Grade 3 Events after TIV were fever and 1 subject with an injection site lump.
Brackets indicate the number of ungraded diagnoses designated possibly or probably vaccine-related. Subject who had graded and ungraded diagnoses were counted separately in this category. These included - LAIV: Possibly = presumed pneumonia; conjunctivitis (2); sinusitis; Probably = pharyngitis (2); asthma. TIV; Possibly = conjunctivitis; Probably = otitis (2); pharyngitis (2); pneumonia.