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Certiva

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Certiva

Side Effects
Interactions

SIDE EFFECTS

In clinical studies in the United States and Sweden, 11,560 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (10,608 intramuscular, 952 subcutaneous) and 30,951 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU (5,574 with thimerosal; 25,377 without thimerosal; all subcutaneous) have been administered.15 In these studies, 3,698 infants received 10,615 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a 3-dose series at 2, 4, and 6 months of age; 682 of these infants received a 4th consecutive dose of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM at 15-24 months of age; no children have received 5 consecutive doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. Forty-two (42) children received Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a 4th dose at 15-22 months of age, following 3 doses of whole-cell DTP vaccine; 221 children received Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a 5 th dose at 4-6 years of age, following 3 doses of whole-cell DTP and a 4 th dose of whole-cell DTP or acellular DTaP vaccine. In addition, 1,875 infants received 5,574 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU as a 3-dose series at 3, 5 and 12 months of age. 14, 15 In an ongoing study, 11,859 infants are completing a 3-dose series at 3, 5, and 12 months of age and have been evaluated after 25,377 doses to date.15 In a comparative study, local and systemic adverse reactions commonly associated with whole-cell DTP vaccination occurred less frequently after vaccination with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. 15 Studies have shown, however, that the rate of erythema, swelling, and fever increased with successive doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (Tables 2, 3, and 6).

In a double-blind safety and immunogenicity study in the United States, 1,303 infants were randomized to receive Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (n=977) or U.S. licensed whole-cell DTP vaccine manufactured by Lederle Laboratories (n=326) at 2, 4, and 6 months of age. At each time point, 96-99% of subjects also received Huemophihs infuenzae type b conjugate vaccine, 83-97% received polio vaccine live oral, and 18-80% received hepatitis B vaccine. Safety data were actively collected using standardized diary cards and follow-up telephone calls at 1, 3, and 7 days after each vaccination, and are available for 972 and 323 infants, respectively, who received at least one dose of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM or whole-cell D.P. Local injection site reactions and systemic reactions such as fever (³ 38o C), irritability, decreased appetite, and drowsiness were significantly less frequent after Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM than after whole-cell DTP (Table 2). Within 7 days after vaccination, there were no deaths and five hospitalizations (3 Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM recipients: 1 with cold/high fever on day 6, 1 with ear infection on day 6, 1 with febrile seizure and respiratory infection on day 4; 2 whole-cell DTP recipients: 1 with diarrhea on day 4, 1 with hives/allergic reaction on day 4), none judged to be vaccine-related by the investigators. 15 

TABLE 2.

ADVERSE EVENTS (%) OCCURRING WITHIN 72 HOURS AFTER INTRAMUSCULAR VACCINATION OF U. S. INFANTS WITH CERTIVA (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM OR WHOLE-CELL DTP AT 2,4, AND 6 MONTHS OF AGE

 

Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM Reaction %

Whole-Cell Pertussis DTP Reaction %

p-values1

Dose 1

2 Mos.

Dose 2

4 Mos.

Dose 3

6 Mos.

Dose 1

2 Mos.

Dose 2

4 Mos.

Dose 3

6 Mos.

Combined Dose DTaP; DTP

N=972

N=898

N=868

N=323

N=295

N=279

N=2,738: 897

Local  
Redness (any)

5.2

8.5

13.0

22.1

29.9

27.2

<0.0001

Redness ³3cm

0.2

0.6

1.3

5.6

1.4

2.2

<0.0001

Swelling (any)

8.0

8.6

8.6

29.9

23.4

20.4

<0.0001

Swelling ³3cm

1.9

1.2

1.3

14.0

9.2

5.0

<0.0001

Tenderness/pain

8.4

6.8

5.4

28.6

15.9

18.0

<0.0001

Systemic2  
Fever ³38o C3

3.2

7.2

11.4

15.7

19.7

25.5

<0.0001

Fever ³39o C3

0.2

1.7

2.1

0

2.5

7.1

NS (p=0.052)

Irritability

34.2

30.3

27.0

55.4

38.6

34.8

<0.0001

Drowsiness

38.3

21.2

12.4

45.2

25.1

20.4

<0.001

Decreased appetite

14.5

11.7

9.2

22.0

10.5

14.3

<0.01

Vomiting

14.3

8.2

7.3

13.3

7.5

6.5

NS

High-pitched/unusual crying

0.3

0

0.1

0.6

0

0

NS*

Persistent crying ³3 hours

0.1

0.1

0

0.6

0

0

NS*

Hypotonic-hyporesponsive episode

0.1**

0

0

0

0

0.7

NS*

Seizures/convulsions

0

0

0

0

0

0.4

NS*


1 Two-tailed Fishers exact test/CestivaTM: whole-cell DTP across all doses

2 Other age-appropriate vaccines concomitantly administered with CestivaTM

3 Rectal temperatures only, denominators for CestivaTM TV at doses 1,2 and 3 are 524, 363 and 282, respectively, and for whole-cell DTP 172,122 and 98, respectively, for a total of 1,169 CestivaTM doses and whole-cell DTP doses

* NS = not significant (p>0.05); study not powered to detect significant differences for the predicted event rates

** Database record represents one subject after dose 1; no medical attention sought, child received doses two, three and four without incident

In an open-label study in the United States, safety results are available from 2,480 infants who received at least one dose of a three-dose series of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM administered at 2, 4, and 6 months of age. At each time point, 95-98% of subjects also received Haemophilus influenzoe type b conjugate vaccine, 71-94% received polio vaccine live oral, and 7-50% received hepatitis B vaccine. Safety data were actively collected using standardized diary cards and follow-up telephone calls at 1, 2, 3, and 7 days after each vaccination (Table 3). Within 7 days after vaccination, there were no reports of seizures, hypotonic-hyporesponsive episodes (HHE), or deaths; seven hospitalizations occurred (bronchiolitis, RSV pneumonia, pyelonephrosis, urinary tract infection, breath-holding episode, stridor, otitis media/fever), none of which were judged to be vaccine-related by the investigators. 15 Of the 2,283 infants who completed the 3-dose series, 3 16 received a 4th dose at 15-24 months of age. Standardized diary cards and telephone follow-up at 2 and 7 days post-vaccination were used to actively collect safety data. There were no reports of serious adverse events during the first 7 days after vaccination. The most common complaints were irritability, injection site redness (of any size) and pain (Table 3).15

TABLE 3.

ADVERSE EVENTS (%) OCCURRING WITHIN 72 HOURS AFTER INTRUIUSCULAR VACCINATION OF U. S. INFANTS WITH CERTIVA (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM AT 2, 4, 6, AND 15-24 MONTHS OF AGE

 

Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM

Dose 1

2 Mos.

Dose 2

4 Mos.

Dose 3

6 Mos.

Dose 4

15 Mos.

N*=2480

N*=2374

N*=2283

N*=316

Local  
Redness (any)

4.4

7.7

10.9

21.0

Redness ³3 cm

0.2

0.3

0.5

5.7

Swelling (any)

3.6

5.4

7.9

12.7

Swelling ³3cm

0.6

0.4

1.1

4.5

Tenderness/pain (any)**

5.9

4.0

3.9

19.0

Systemic a  
Fever ³38o C b

1.5

3.5

5.0

10.5

Fever ³39o C b, c

0.1

0.4

1.0

2.6

Irritability

33.4

27.9

26.4

22.5

Drowsiness

33.5

17.1

11.1

11.4

Decreased appetite

15.4

10.5

10.0

8.9

Vomiting/spitting up

7.3

4.9

4.5

3.8

High-pitched/unusual crying

0.2

0.1

0

0

Persistent crying ³3 hours c

0.1

0.04

0

0


*Denommators vary less than 1.2% from the column totals

** 85% of events reported were mild in intensity

a Other age-appropriate vaccines concomitantly administered with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM

b Rectal temperatures only, fever rates based on 6,447 total Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM doses at 2.4, and 6 months of age, and 266 at 15 months of age

c Within 48 hours of vaccination, there were no fevers ³40.3o C (rectal) and no persistent, inconsolable crying ³3 hours

In an open-label study, 175 children who had previously received either whole-cell DTP (n=42) or Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (n=133) at 2, 4, and 6 months of age were immunized with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) m at 15-21 months of age. Standardized diary cards and telephone follow-up at 2 and 7 days post-vaccination were used to actively collect safety data (Table 4).

TABLE 4.

ADVERSE EVENTS (%) OCCURRING WITHIN 72 HOURS FOLLOWING AN INTRAMUSCULAR DOSE OF CERTIVA (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM AT 15-21 MONTHS OF AGE IN CHILDREN WHO RECEIVED THREE DOSES OF CERTIVA (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM OR WHOLE-CELL DTP VACCINE AT 2,4, AND 6 MONTHS OF AGE15

Events

Vaccine received at 2, 4, and 6 mo. of age

Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM

Whole-Cell DTP

N=133

N=42

Local (any)  
Redness

15.3

7.1

Swelling

9.9

9.5

Pain

9.0

7.1

Systemic a  
Fever >/=38o C b

2.1

15.4

Decreased appetite

9.8

14.3

Vomiting

3.8

0

Drowsiness

7.5

14.3

Irritability

19.6

21.4

High-pitched/unusual crying

0

0

Persistent crying ³3 hours

0.8 c

0

 

a Other age-appropriate vaccines concomitantly administered with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM

b Denominators for rectal temperatures for Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM primed and whole-cell DTP primed subjects are 48 and 13, respectively, 38oC =100.4o F

c Represents one subject who was bitten by ants

Table 5 lists the fkquency of adverse reactions in 221 U. S. children who received Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM at 4-6 years of age. These children had previously received 3 doses of a whole-cell DTP vaccine at 2, 4, and 6 months of age and either a whole-cell DTP or DTaP vaccine at 12-24 months of age.

TABLE 5.

ADVERSE EVENTS (%) OCURRING WITHIN 7 DAYS FOLLOWING AN INTRAMUSCULAR DOSE OF CERTIVA (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM AT 4-6 YEARS OF AGE (5th DOSE IN THE SERIES) IN 221 CHILDREN HAVING RECEIVED ALL OF THEIR PREVIOUS AGE-APPROPRIATE PERTUSSIS VACCINATIONS15

Local Events (any)

Systemic Events**

Redness

Swelling

Pain*

Fever>38oC

Decreased Appetite

Vomiting

Drowsiness

Irritability

19.5

18.1

36.2

4.5

6.8

5.0

10.0

8.1

 

*83% of subjects reported pain of mild intensity, the remaining 17% were of moderate intensity as judged by the caregiver

**Other age-appropriate concomitantly administered with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM

In the randomized, double-blinded, placebo-controlled efficacy trial in Göteborg, Sweden, a total of 3,450 infants were vaccinated with either DT (1,726 infants) or Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU (1,724 infants) at 3, 5, and 12 months of age; no other vaccines were administered concurrently. Safety data were actively collected using standardized diary cards and telephone follow-up 7 days after each vaccination and monthly for general health and disease surveillance. Within 7 days after vaccination, there were no reports of hypotonic-hyporesponsive episodes or deaths; 28 hospitalizations (12 Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU, 16 DT) occurred, none judged to be vaccine-related by the investigators. Rates of both fever and local injection site reactions increased with the number of vaccinations in both groups. Rates for fever were similar between the two groups within the first seven days following a vaccination. Injection site redness and swelling were more common among Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU- vaccinated than among DT-vaccinated children after the second injection (Table 6). 14, 15

TABLE 6.

ADVERSE EVENTS (%) OCCURRlNG AFTER SUBCUTANEOUS* VACCINATION OF SWEDISH INFANTS WITH CERTIVA (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM-EU AT 3,5, AND 12 MONTHS OF AGE

 

Dose l

3 Mos

Dose 2

5 Mos.

Dose 3

12 Mos.

Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM-EU

DT

Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM-EU

DT

Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM-EU

DT

N=

1724

1726

1708

1717

1692

1687

Within 7 days of vaccination  
Redness (any)

22.2

18.8

50.9

39.5

57.6

49.3

Redness ³4 cm

0.1

0.2

2.0

0.8

10.0

7.9

Swelling (any)

10.8

10. 5

34.7

28.7

45.9

38.9

Swelling ³4 cm

0.2

0.2

1.9

0.9

9.1

6.7

Seizures**

0

0

0

0

0.2

0

Within 48 hours of vaccination  
Fever ³38° C a

6.4

6.5

10.9

11.4

16.8

16.6

Fever ³39° C a

0.5

0

1.4

0.8

2.5

2.3

Persistent crying ³3 hrs

0.1

0.2

0.2

0.1

0

0


 *Subcutaneous-administration may result in an increased frequency of local injection site complaints when compared to intramuscular administration.14 CertivaTM is for intramuscular injection only (see DESCRIPTIONand DOSAGE AND ADMINISTRATION)

**Three febrile events: two with concomitant respiratory tract infection and one with concomitant gastroenteritis; no afebrile seizures were reported

a Rectal temperatures

Other adverse events (irritability, crying, feeding problems, vomiting, sleeping problems, respiratory infections, diarrhea and physician visits) were seen with similar frequency in the two groups after each vaccination. When the total U.S. clinical trial experience with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is considered (10,587 doses administered to 3,715 infants and children), adverse event rates per 1,000 doses meeting AAP and ACIP criteria as absolute contraindications or precautions to further pertussis immunization and occurring within 72 hours after immunization were: persistent, inconsolable crying for ³3 hours, 0.57; fever ³40.5o C, 0; seizures (febrile and afebrile), 0; hypotonic-hyporesponsive episode, 0.09 (database record represents one subject after dose 1; no medical attention sought; child received doses 2, 3, and 4 without incident).

For Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU (5,574 doses containing thimerosal administered to 1,875 Swedish infants with active follow-up) rates per 1,000 doses for similar adverse events occurring within 7 days of vaccination were the following: persistent crying for ³3 hours, 1.44; fever ³40.5o C, 1.79; seizures (febrile) within 48 hours of vaccination, 0.36; hypotonic-hyporesponsive episode, 0. Rates of serious adverse events that are less common than those reported in these actively monitored trials are not known at this time.

In an open-label study in Sweden, 11,859 infants have received 25,377 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU (without thimerosal) at 3, 5, and 12 months of age, and serious adverse events were ascertained through evaluation of hospitalization databases and spontaneous reporting. Within 7 days after vaccination, there were three hospitalizations for seizures (2 within 48 hours after vaccination); no hospitalizations for diagnoses judged by the investigators to be consistent with hypotonic-hyporesponsive episodes; and two deaths attributed to Sudden Infant Death Syndrome (SIDS), neither judged to be vaccine-related.15 In this study, 32,799 children l-5 years of age have received 8 1,613 doses of a vaccine containing pertussis toxoid (but not the tetanus and diphtheria toxoids; 6,764 doses were administered as Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU as the first dose at 1 year of age) on a 0, 2, and 8 month schedule, and were monitored the same way as the infants. Within 7 days after vaccination, there were seven hospitalizations for seizures (none within 48 hours after vaccination); no hospitalizations for diagnoses judged by the investigators to be consistent with hypotonic-hyporesponsive episodes; and no deaths.

In the overall clinical trial experience involving 17,690 infants and children who received 42,490 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM or Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU, there were no occurrences of anaphylaxis or encephalopathy. Nine deaths were reported, two occurring within 7 days after vaccination; none of these events was determined to be related to vaccination. Causes of death included four cases of Sudden Infant Death Syndrome (SIDS), 1 accidental suffocation, 1 invasive bacterial infection, 1 cerebral edema (unknown cause), 2 unknown (history of cardiac malformation or myelomeningocele).15 The rate of SIDE was 0.6 per thousand infants vaccinated with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in the U. S. studies, and 0.1 per thousand infants vaccinated with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU in Swedish studies.15 The incidence of SIDE in Sweden from 1985-1992 was between 0.7 and 1.1 cases per thousand live births with a decline from 0.7 to 0.4 cases per thousand live births between 1992 and 1995.31, 32 From 1979 to 1996, the incidence of SIDE in the U. S. has declined from 1.5 to 0.74 cases per thousand live births. 33 By chance alone, some cases of SIDE can be expected to follow receipt of whole-cell DTP or DTaP. 21 In the clinical trial experience of 32,799 children who received 81,613 doses of pertussis toxoid vaccine, there were no reports of anaphylaxis or encephalopathy. 15 Of five reported deaths, none occurred within 7 days after vaccination and none was determined to be related to vaccination. Causes of death included 1 invasive bacterial infection, 1 unexpected sudden death, 1 murder, 1 hepatoblastoma, and 1 unknown (history of cardiac malformation). 15 Rarely, an anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension or shock) has been reported after receiving preparations containing diphtheria, tetanus, and/or pertussis antigens. 3

Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection) may follow receipt of tetanus toxoid. A few cases of peripheral neuropathy have been reported following tetanus toxoid administration, although the IOM concluded that the evidence is inadequate to accept or reject a causal relation.34 A review by the IOM found a causal relation between tetanus toxoid and brachial neuritis and Guillain-Barre Syndrome.34 The following illnesses have been reported as temporally associated with the administration of tetanus toxoid containing vaccines: neurological complications35, 36 including cochlear lesion37 I brachial plexus neuropathies38, paralysis of the radial nerve39, paralysis of the recurrent laryngeal nerve, accommodation paresis, and EEG disturbances with encephalopathy.40, 41 In the differential diagnosis of polyradiculoneuropathies following administration of a vaccine containing tetanus toxoid, tetanus toxoid should be considered as a possible etiology.41

Additional Adverse Reactions Evaluated in Conjunction with whole-cell DTP Vaccination: Whole-cell DTP has been associated with acute encephalopathy.27 In the National Childhood Encephalopathy Study (NCES), a large, case-control study in England, children 2 to 35 months of age with serious acute neurologic disorders (cases), such as encephalopathy or complicated convulsion(s), were compared to children without acute neurologic disorders who were matched for age, sex, and residence (controls).42 Cases were more likely to have received whole-cell DTP vaccine within 7 days before onset of illness than were controls within 7 days before being the exact age as their matched case child at the time of onset of illness (relative risk, 3.3). The attributable risk for all neurologic events was estimated to be 1:140,000 doses of whole-cell DTP vaccine administered.42

A detailed follow-up to the NCES indicated that cases were significantly more likely than controls to have chronic nervous system dysfunction 10 years later.43 These cases who developed chronic nervous system dysfunction were more likely to have received whole-cell DTP vaccine within 7 days before onset of acute illness than were controls within 7 days before being the exact age as their matched case child at the time of onset of acute illness (relative risk, 5.5). A committee of the IOM has concluded that the evidence is consistent with a causal relation between whole-cell DTP and acute neurologic illness, and that the balance of the evidence is consistent with a causal relation between whole-cell DTP and the forms of nervous system dysfunction described in the NCES in those children who experience a serious acute neurologic illness within 7 days after receiving whole-cell DTP vaccine. However, the IOM committee also concluded that the evidence is insufficient to indicate whether or not whole-cell DTP increases the overall risk in children for chronic nervous system dysfunction.27 The ACIP indicated that the results of the NCES were insufficient to determine whether whole-cell DTP administration before the acute neurological event influenced† the potential for neurologic dysfunction 10 years later. 20 Subsequent studies have failed to provide evidence in support of a causal relationship between whole-cell DTP vaccination and either serious acute neurologic illness or permanent neurologic injury. 36, 44, 45, 46

Onset of infantile spasms has occurred in infants who have recently received whole-cell DTP vaccines or DT. Analysis of data from the NCES on children with infantile spasms showed that receipt of DT or whole-cell DTP vaccines was not causally related to infantile spasms. 26, 47 The incidence of onset of infantile spasms increases at 3 to 9 months of age, the time period in which the second and third doses of vaccine are generally given. Therefore, some cases of infantile spasms can be expected to be related by chance alone to recent receipt of whole-cell DTP vaccine.26.47

Sudden Infant Death Syndrome (SIDS) has been reported in infants following administration of whole-cell DTP or DTaP vaccine. Large case-control studies of SIDE in the U. S. have shown that receipt of whole-cell DTP vaccine was not causally related to SIDS. 26, 48, 49 It should be recognized that the first three immunizing doses of whole-cell DTP vaccine or DTaP vaccine are usually administered to infants 2 to 6 months old and that approximately 85% of SIDE cases occur at ages 1 to 6 months, with the peak incidence occurring at 6 weeks to 4 months of age. By chance alone, some cases of SIDE can be expected to follow receipt of whole-cell DTP or DTaP vaccine. 48 A review by a committee of the IOM concluded that available evidence did not indicate a causal relation between whole-cell DTP vaccines and SIDS. 26

A bulging fontanel associated with increased intracranial pressure which occurred within 24 hours following whole-cell DTP immunization has been reported, although a causal relationship has not been established. 26, 35

The above findings regarding possible association of unusual neurologic events and SIDE relate only to DTP vaccines containing whole-cell pertussis. At this time there are insufficient data to determine their relevance to Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM immunization. 

ADVERSE EVENT REPORTING

Adverse events occurring after vaccine administration should be reported by the health-care provider to the U. S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS). 30 The toll-free number for VAERS forms and information is l-800-822-7967. 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 (including a record of the name of the vaccine manufacturer, lot number of the vaccine administered, date of administration and the name, address and title of the person administering the vaccine) and to report occurrences of certain adverse events to the U. S. Department of Health and Human Services. Reportable events include those listed in the Act (i.e., those listed in the Vaccine Injury Table) for each vaccine and events specified in the package insert as contraindications to further doses of the vaccine.29, 30

The health-care provider also should report these events to the Director of Medical Affairs, North American Vaccine, Inc., 12103 Indian Creek Court, Beltsville, Maryland 20705, or call toll-free l-888-NAVAVAX (l-888-628-2829). 

Read the Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

For information regarding simultaneous administration with other vaccines, refer to DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY.

As with other intramuscular injections, the vaccine should not be given to infants or children on anticoagulant therapy, unless the potential benefit clearly outweighs the risk of administration (see WARNINGS).

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (administered in greater than physiologic doses), may reduce the immune response to vaccines. Although no specific studies with pertussis-containing vaccines under these circumstances are available, if immunosuppressive therapy will be discontinued shortly, it would be reasonable to defer immunization until the patient has been off therapy for 365 at least one month; otherwise, the patient should be vaccinated while still on therapy.3, 28 If Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM has been administered to persons receiving immunosuppressive therapy, receiving a recent injection of immune globulin or having an immunodeficiency disorder, an adequate immunologic response may not be obtained.

Tetanus Immune Globulin, or Diphtheria Antitoxin, if used, should be given in a separate site, with a separate needle and syringe.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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