Apr 13
INCLUDING PATIENT MEDICATION INFORMATION
M-M-R® II
(measles, mumps and rubella virus vaccine, live, attenuated, Merck Std.)
Lyophilized powder for injection
0.5 mL for Intramuscular and Subcutaneous
Injection
Active Immunizing Agent
ATC code: J07BD52
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Submission Control Number: 282235
8.5 Post-Market Adverse Reactions
Subacute Sclerosing Panencephalitis (SSPE)
There have been reports of SSPE in children who did not have a history of infection with wild-type
measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized
measles in the first year of life or possibly from the measles vaccination. Based on estimated
nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about
one case per million vaccine doses distributed. This is far less than the association with infection with
wild-type measles, 6–22 cases of SSPE per million cases of measles. The results of a retrospective case
controlled study conducted by the Centers for Disease Control and Prevention suggest that the overall
effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent
higher risk of SSPE.
Aseptic Meningitis
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination. A
causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been
shown. Although a temporal association has been observed between the administration of M-M-R® II
and rare cases of aseptic meningitis, there is no laboratory-confirmed evidence to link Jeryl Lynn®
mumps vaccine to aseptic meningitis.
Encephalitis/encephalopathy
Encephalitis/encephalopathy have been reported approximately once for every 3 million doses of the
measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. Since 1978, post-marketing
surveillance indicates that serious adverse events such as encephalitis and encephalopathy continue to
be rarely reported. The risk of such serious neurological disorders following live measles virus vaccine
Page 16 of 33
M-M-R® II (measles, mumps and rubella virus vaccine, live, attenuated, Merck Std.)
M-M-R® II
(measles, mumps and rubella virus vaccine, live, attenuated, Merck Std.)
Lyophilized powder for injection
0.5 mL for Intramuscular and Subcutaneous
Injection
Active Immunizing Agent
ATC code: J07BD52
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Submission Control Number: 282235
8.5 Post-Market Adverse Reactions
Subacute Sclerosing Panencephalitis (SSPE)
There have been reports of SSPE in children who did not have a history of infection with wild-type
measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized
measles in the first year of life or possibly from the measles vaccination. Based on estimated
nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about
one case per million vaccine doses distributed. This is far less than the association with infection with
wild-type measles, 6–22 cases of SSPE per million cases of measles. The results of a retrospective case
controlled study conducted by the Centers for Disease Control and Prevention suggest that the overall
effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent
higher risk of SSPE.
Aseptic Meningitis
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination. A
causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been
shown. Although a temporal association has been observed between the administration of M-M-R® II
and rare cases of aseptic meningitis, there is no laboratory-confirmed evidence to link Jeryl Lynn®
mumps vaccine to aseptic meningitis.
Encephalitis/encephalopathy
Encephalitis/encephalopathy have been reported approximately once for every 3 million doses of the
measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. Since 1978, post-marketing
surveillance indicates that serious adverse events such as encephalitis and encephalopathy continue to
be rarely reported. The risk of such serious neurological disorders following live measles virus vaccine
Page 16 of 33
M-M-R® II (measles, mumps and rubella virus vaccine, live, attenuated, Merck Std.)
