2005 - FDA approves ProQuad combination MMR and chickenpox vaccine

June 20, 2007

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FDA approves ProQuad combination MMR and chickenpox vaccine

[Published: 07 September 2005 Source: Anti-Infective Drug News from Espicom]

The FDA has approved Merck & Co's combination vaccine, ProQuad (measles,

mumps, rubella [MMR] and varicella virus vaccine live) for simultaneous

vaccination against MMR and varicella in children aged 12 months to 12

years. ProQuad, combines Merck's M-M-R II (MMR virus vaccine live) and

Varivax (varicella virus vaccine live) and is the first vaccine approved in

the US to help protect against these four diseases in a single shot. It is

also approved for use in children 12 months to 12 years of age if a second

dose of MMR vaccine is to be administered.

Merck's BLA for the combination vaccine included results from studies that

evaluated the immunogenicity, antibody (Ab) persistence and safety of

ProQuad compared to its component vaccines.

Immunogenicity was studied in 5,835 healthy children aged 12 months to six

years, with a negative clinical history of MMR and varicella, who

participated in five randomised trials. In these trials, the immunogenicity

of ProQuad was similar to that of its individual component vaccines.

In four randomised trials in which 5,446 healthy children aged 12 to 23

months received ProQuad, vaccine response rates for ProQuad were similar to

the rates induced by the concomitant administration of single doses of M-M-R

II and Varivax at separate injection sites in 2,038 children. Results showed

that following a single dose of ProQuad, the immune response rates were 97.4

per cent for measles, 95.8 to 98.8 per cent for mumps, 98.5 per cent for

rubella and 91.2 per cent for chickenpox. The duration of protection from

MMR and chickenpox infections after vaccination with ProQuad is unknown.

In two of the four trials, 1,035 of the 5,446 children administered a single

dose of ProQuad received a second dose approximately three months after the

first dose. The proportion of initially seronegative vaccinees with positive

serological responses following two doses were 99.4 per cent for measles,

99.9 per cent for mumps, 98.3 per cent for rubella and 99.4 per cent for

chickenpox. The rates of adverse experiences (AEs) after the second dose

were generally similar to, or lower than, those seen with the first dose.

The fever rate was lower after the second dose of ProQuad than after the

first dose.

The immunogenicity of ProQuad was also evaluated in a clinical trial of 799

healthy children four to six years of age who had received M-M-R II and

Varivax as primary vaccination against MMR and chickenpox at least one month

prior to study entry. In this study, 399 children received ProQuad and

placebo, 205 received M-M-R II and placebo concomitantly at separate

injection sites and 195 children received M-M-R II and Varivax concomitantly

at separate injection sites. Following the dose of ProQuad, seropositivity

rates were 99.2 per cent for measles, 99.5 per cent for mumps, 100 per cent

for rubella and 98.9 for varicella. The rates of AEs, including the most

commonly-reported AEs of injection site reactions, nasopharyngitis and

cough, were generally similar among the three treatment groups.

Formal studies to evaluate the clinical efficacy of ProQuad have not been

performed. Efficacy of the MMR and chickenpox components of ProQuad was

previously established in a series of clinical studies with the monovalent

vaccines. A high degree of protection from infection was demonstrated in

these studies.

In clinical trials, the safety of ProQuad was compared with the safety of

M-M-R II and Varivax given concomitantly at separate injection sites.

ProQuad was administered to 4,497 children 12 to 23 months of age without

concomitant administration with other vaccines. Children in these studies

were monitored for up to 42 days post-vaccination. The safety profile for

ProQuad was similar to the component vaccines. Injection-site AEs reported

in >=1 per cent of children 12 to 23 months of age who received one dose of

ProQuad were: pain/tenderness/soreness (22 per cent), erythema (14.4 per

cent), swelling (8.4 per cent), ecchymosis (1.5 per cent) and rash (2.3 per

cent). Pain/tenderness/soreness at the injection site was reported at a

statistically lower rate in individuals who received ProQuad than in

individuals who received M-M-R II and Varivax concomitantly at separate

injection sites.

Systemic vaccine-related AEs reported in >=1 per cent of children 12 to 23

months of age who received one dose of ProQuad were fever >=102°F (21.5 per

cent), irritability (6.7 per cent), measles-like rash (3 per cent),

varicella-like rash (2.1 per cent), rash not otherwise specified (1.6 per

cent), upper respiratory infection (1.3 per cent), viral exanthema (1.2 per

cent) and diarrhoea (1.2 per cent). The only systemic vaccine-related AEs

reported at a significantly greater rate in individuals who received ProQuad

than individuals who received M-M-R II and Varivax concomitantly at separate

injection sites were fever (>=102°F) and measles-like rash. Both fever and

measles-like rash usually occurred within five to 12 days following

vaccination, were of short duration and resolved with no long-term issues.

The persistence of Ab at one year after vaccination was evaluated in 2,107

children enrolled in clinical trials. Ab persistence rates one year after a

single dose of ProQuad were 98.9 per cent against measles, 96.7 per cent

against mumps, 99.6 per cent against rubella and 97.5 per cent against

chickenpox. These persistence rates are similar to those observed at one

year with the individual component vaccines.

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2005 - FDA approves ProQuad combination MMR and chickenpox vaccine

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