A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ipol Side Effects, and Drug Interactions - Poliovirus Vaccine
Ipol Side Effects, and Drug Interactions - Poliovirus Vaccine
SIDE EFFECTS
BODY SYSTEM AS A WHOLE
In earlier studies with the vaccine
grown in primary monkey
kidney cells, transient
local reactions at the
site of injection
were observed.9 Erythema, induration
and pain occurred in 3.2%,
1% and 13%, respectively, of vaccinees within 48 hours post-vaccination.
Temperatures of ³390C
(³1020F) were reported
in 38% of vaccinees. Other symptoms included irritability, sleepiness,
fussiness, and crying. Because IPV was given in a different site
but concurrently with Diphtheria and Tetanus Toxoids and Pertussis
Vaccine Adsorbed (DTP), these systemic
reactions could not be attributed to a specific
vaccine. However, these systemic reactions were comparable in frequency
and severity to that reported for DTP given alone without IPV.10
Although no causal relationship
has been established, deaths have occurred in temporal
association after
vaccination of infants with IPV.
Four additional US studies using IPOL0 in more than
1,300 infants,10 between two to eighteen months of age
administered with DTP at the same time
at separate sites or combined have demonstrated that local
and systemic reactions
were similar when DTP was given alone.
TABLE 210 PERCENTAGE OF INFANTS PRESENTING
WITH LOCAL OR SYSTEMIC
REACTIONS AT 6, 24, AND 48 HOURS OF IMMUNIZATION WITH IPOLÒ
ADMINISTERED INTRAMUSCULARLY CONCOMITANTLY AT SEPARATE SITES WITH
CLI WHOLE-CELL DTP VACCINE AT 2 AND 4 MONTHS OF AGE AND WITH CLI
ACELLULAR PERTUSSIS VACCINE (TRIPEDIAÒ)AT
18 MONTHS OF AGE
| |
AGE AT IMMUNIZATION
|
| REACTION |
2 Months
|
4 Months
|
18 Months †
|
| |
(n=211)
|
(n=206)
|
(n=74)
|
| |
6 Hrs.
|
24 Hrs.
|
48 Hrs.
|
6 Hrs.
|
24 Hrs.
|
48 Hrs.
|
6 Hrs.
|
24 Hrs.
|
48 Hrs.
|
| Local, IPOL®
alone§ |
|
|
|
|
|
|
|
|
|
| Erythema > 1"
|
0.5%
|
0.5%
|
0.5%
|
1.0%
|
0.0%
|
0.0%
|
1.4%
|
0.0%
|
0.0%
|
| Swelling |
11.4%
|
5.7%
|
0.9%
|
11.2%
|
4.9%
|
1.9%
|
2.7%
|
0.0%
|
0.0%
|
| Tenderness |
29.4%
|
8.5%
|
2.8%
|
22.8%
|
4.4%
|
1.0%
|
13.5%
|
4.1%
|
0.0%
|
| Systemic* |
|
|
|
|
|
|
|
|
|
| Fever > 102.2°F
|
1.0%
|
0.5%
|
0.5%
|
2.0%
|
0.5%
|
0.0%
|
0.0%
|
0.0%
|
4.2%
|
| Irritability |
64.5%
|
24.6%
|
17.5%
|
49.5%
|
25.7%
|
11.7%
|
14.7%
|
6.7%
|
8.0%
|
| Tiredness |
60.7%
|
31.8%
|
7.1%
|
38.8%
|
18.4%
|
6.3%
|
9.3%
|
5.3%
|
4.0%
|
| Anorexia |
16.6%
|
8.1%
|
4.3%
|
6.3%
|
4.4%
|
2.4%
|
2.7%
|
1.3%
|
2.7%
|
| Vomiting |
1.9%
|
2.8%
|
2.8%
|
1.9%
|
1.5%
|
1.0%
|
1.3%
|
1.3%
|
0.0%
|
| Persistent Crying
|
Percentage
of infants within 72 hours after immunization
was 0.0% after dose
one,
1.4% after dose
two, and 0.0% after dose
three.
|
| |
§ Data are from the IPOLÒ
administration site, given intramuscularly.
* The adverse reaction
profile includes the
concomitant use
of CLI whole-cell DTP vaccine
or TripediaÒ with IPOLÒ.
Rates are comparable in frequency
and severity to that reported for whole-cell DTP given alone.
† Children vaccinated with TripediaÒ
vaccine.
DIGESTIVE SYSTEM
Anorexia and vomiting
occurred with frequencies not significantly different as reported
when DTP was given alone without IPV or OPV.10
NERVOUS SYSTEM
Although no causal relationship
between IPOLÒ and GBS
has been established,32 GBS
has been temporally related to administration
of another inactivated poliovirus
vaccine.
Reporting of Adverse Events
The National Vaccine Injury Compensation Program, established by
the National Childhood Vaccine Injury Act of 1986, requires physicians
and other health-care providers who administer vaccines to maintain
permanent vaccination records and to report
occurrences of certain adverse events to the US Department of Health
and Human Services. Reportable events include those listed in the
Act for each vaccine
and events specified in the package insert as contraindications
to further doses of that vaccine.41,42,43
Reporting by parents or guardians of all adverse events after vaccine
administration should be encouraged. Adverse events following immunization
with vaccine should
be reported by health- care providers to the US Department of Health
and Human Services (DHHS) Vaccine Adverse Event Reporting System
(VAERS). Reporting forms and information about reporting requirements
or completion of the form
can be obtained from VAERS through a toll-free number 1-800-822-7967.41,42,43
Health care providers also should report
these events to the Director of Medical Affairs, Connaught Laboratories,
Inc., Route 611, PO Box 187, Swiftwater, PA
18370 or call 1-800-822-2463.
DRUG INTERACTIONS
There are no known interactions
of IPOLÒ with drugs
or foods. Simultaneous administration, with separate syringes at
separate sites, of other parenteral
vaccines is not contraindicated. The first two doses of IPOLÒ
may be administered at separate sites using separate syringes concomitantly
with D.P. acellular
pertussis, Haemophilus
influenzae type b (Hib),
and hepatitis B vaccines.
From historical data on the antibody
responses to diphtheria, tetanus, whole-cell or acellular
pertussis, Hib, or
hepatitis B vaccines used concomitantly or in combination with IPOLÒ,
no interferences have been observed on the immunological end
points accepted for clinical
protection.8,12,40 (See DOSAGE
AND ADMINISTRATION section).
If IPOLÒ has been
administered to persons receiving immunosuppressive therapy,
an adequate immunologic response may not be obtained. (See
PRECAUTIONS - General)
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