TABLE 1.
Symptom | No. of subjects with symptom or % of groupa
|
||||||||
---|---|---|---|---|---|---|---|---|---|
1st immunization
|
2nd immunization
|
||||||||
i.m. | Nasal
|
Nasal
|
|||||||
Naive
|
Ipsilateral preimmunized | % of whole group | Naive
|
Ipsilateral preimmunized | % of whole group | ||||
Contralateral | Ipsilateral | Contralateral | Ipsilateral | ||||||
Injection site pain | 4 | 66 | |||||||
Mild | 4 | 66 | |||||||
Nasal discharge | 3 | 4 | 6 | 48 | 0 | 1 | 4 | 19 | |
Mild | 2 | 2 | 6 | 19 | 0 | 1 | 4 | 19 | |
Moderate | 1 | 2 | 0 | 11 | 0 | 0 | 0 | 0 | |
Nasal discomfort | 0 | 3 | 3 | 22 | 1 | 2 | 4 | 26 | |
Mild | 0 | 1 | 2 | 11 | 0 | 1 | 3 | 15 | |
Moderate | 0 | 2 | 1 | 11 | 1 | 1 | 1 | 11 | |
Nasal congestion | 2 | 0 | 5 | 26 | 1 | 1 | 3 | 19 | |
Mild | 2 | 0 | 5 | 26 | 1 | 1 | 2 | 15 | |
Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | |
Headache | 2 | 4 | 2 | 30 | 1 | 1 | 4 | 22 | |
Mild | 0 | 3 | 1 | 15 | 0 | 1 | 1 | 7 | |
Moderate | 1 | 1 | 1 | 11 | 1 | 0 | 3 | 15 | |
Severe | 1 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | |
Sneezing | 2 | 1 | 1 | 15 | 0 | 1 | 1 | 7 | |
Mild | 1 | 0 | 1 | 7 | 0 | 1 | 1 | 7 | |
Moderate | 1 | 1 | 0 | 7 | 0 | 0 | 0 | 0 | |
Sore throat | 0 | 1 | 0 | 4 | 1 | 1 | 0 | 7 | |
Mild | 0 | 1 | 0 | 4 | 0 | 1 | 0 | 4 | |
Moderate | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | |
Itchy nose | 1 | 1 | 0 | 7 | 0 | 1 | 0 | 4 | |
Mild | 0 | 1 | 0 | 4 | 0 | 1 | 0 | 4 | |
Moderate | 1 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | |
Watery eyes | 1 | 0 | 0 | 4 | 2 | 0 | 0 | 7 | |
Mild | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | |
Moderate | 1 | 0 | 0 | 4 | 1 | 0 | 0 | 4 | |
Eye pain | 0 | 1 | 1 | 7 | 0 | 0 | 0 | 0 | |
Mild | 0 | 1 | 1 | 7 | 0 | 0 | 0 | 0 | |
Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of subjects recording symptoms on the diary card during 28 days after each immunization other than those designated as “unrelated” or “remote” relationship to immunization. Subjects may have had more than one occurrence of any symptom during this time but are counted only once. Row percentages are calculated for the 27 subjects in the nasal group and 6 subjects in the intramuscular (i.m.) groups. Severity grades were omitted if no subjects reported symptoms of that grade.