The Adverse Event Monitoring Substudy (AEMS) of the Shingles Prevention Study (SPS), designed to
provide detailed data on the safety profile of the zoster vaccine, used vaccination report cards (VRC)
to record adverse events occurring from Days 0 to 42 postvaccination. The table below shows
vaccine-related, injection-site adverse experiences reported in >1% of adults who
received ZOSTAVAX or placebo.
Read below for Study Design 
About ZOSTAVAX
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).
Select Safety Information
Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.
ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.
Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). The rate of serious adverse reactions from Days 0 to 42 postvaccination may be increased. Common adverse reactions occurring in >1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.
Transmission of vaccine virus may occur between vaccinees and susceptible contacts. Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
aPatients instructed to report adverse experiences on a Vaccination Report Card.
bDesignates a solicited adverse experience on the Vaccination Report Card. Injection-site adverse reactions were
solicited within 5 days postvaccination.
Headache was the only systemic adverse reaction reported on the vaccine report card between Days 0-42 by >1% of subjects in the AE Monitoring Substudy (AEMS) in either vaccination group (ZOSTAVAX 1.4%, placebo 0.8%).
Read below for Study Design
About ZOSTAVAX
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).
Select Safety Information
Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.
ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.
Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). The rate of serious adverse reactions from Days 0 to 42 postvaccination may be increased. Common adverse reactions occurring in >1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.
Transmission of vaccine virus may occur between vaccinees and susceptible contacts. Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
aPatients instructed to report adverse experiences on a Vaccination Report Card.
bDesignates a solicited adverse experience on the Vaccination Report Card. Injection-site adverse reactions were
solicited within 5 days postvaccination.
Serious Adverse Experiences (SAEs)
- From Day 0 to 42 postvaccination, in the overall study population, SAEs occurred at a similar rate
(1.4%) in subjects vaccinated with ZOSTAVAX or placebo. In the AE Monitoring Substudya, the rate of SAEs was increased in the group who received ZOSTAVAX (1.9%) as compared to the placebo group (1.3%) from
Day 0 to 42 postvaccination.
- Over the course of the entire study, in the overall study population, investigator-determined,
vaccine-related SAEs were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation
and polymyalgia rheumatica) and 3 subjects who received placebo
(Goodpasture’s syndrome, anaphylactic reaction, and polymyalgia rheumatica).
Read below for Study Design
About ZOSTAVAX
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).
Select Safety Information
Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.
ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.
Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). The rate of serious adverse reactions from Days 0 to 42 postvaccination may be increased. Common adverse reactions occurring in >1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.
Transmission of vaccine virus may occur between vaccinees and susceptible contacts. Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
aPatients instructed to report adverse experiences on a Vaccination Report Card.
bDesignates a solicited adverse experience on the Vaccination Report Card. Injection-site adverse reactions were
solicited within 5 days postvaccination.
Selected Serious Adverse Experiences (Selected SAEs)
- Among reported SAEs in the SPS (Days 0–42 postvaccination), serious cardiovascular events occurred
more frequently in subjects who received ZOSTAVAX (20 [0.6%]) than in subjects who received
placebo (12 [0.4%]) in the AE Monitoring Substudy.a
- The frequencies of serious cardiovascular events were similar in subjects who received ZOSTAVAX (81
[0.4%]) and in subjects who received placebo (72 [0.4%]) in the entire SPS study cohort (Days 0–42
postvaccination).
Read below for Study Design
About ZOSTAVAX
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).
Select Safety Information
Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.
ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.
Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). The rate of serious adverse reactions from Days 0 to 42 postvaccination may be increased. Common adverse reactions occurring in >1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.
Transmission of vaccine virus may occur between vaccinees and susceptible contacts. Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
aPatients instructed to report adverse experiences on a Vaccination Report Card.
bDesignates a solicited adverse experience on the Vaccination Report Card. Injection-site adverse reactions were
solicited within 5 days postvaccination.
Additional Safety Information
- Transmission of vaccine virus may occur rarely between vaccinees and susceptible contacts.
- ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).
- As with any vaccine, adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.
- The duration of protection beyond 4 years after vaccination with ZOSTAVAX is unknown.The need
for revaccination has not been defined.
- Vaccination should be deferred in patients with active untreated tuberculosis.
- Deferral should be considered in acute illness, for example, in the presence of fever.
About ZOSTAVAX
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).
Select Safety Information
Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.
ZOSTAVAX is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.
Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). The rate of serious adverse reactions from Days 0 to 42 postvaccination may be increased. Common adverse reactions occurring in >1% of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.
Transmission of vaccine virus may occur between vaccinees and susceptible contacts. Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
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