Vaccine Information: FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE (Page 3 of 6)
13 NON-CLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)].
14 CLINICAL STUDIES
The effectiveness of Fluzone Quadrivalent was demonstrated based on clinical endpoint efficacy data for Fluzone (trivalent influenza vaccine) and on an evaluation of serum HI antibody responses to Fluzone Quadrivalent. Fluzone Quadrivalent, an inactivated influenza vaccine that contains the hemagglutinins of two influenza A subtype viruses and two influenza type B viruses, is manufactured according to the same process as Fluzone.
Fluzone Quadrivalent Southern Hemisphere and Fluzone Quadrivalent are manufactured using the same process. Data in this section were obtained in studies with Fluzone Quadrivalent.
14.1 Efficacy of Fluzone (Trivalent Influenza Vaccine) in Children 6 through 24 Months of Age
A randomized, double-blind, placebo-controlled study was conducted at a single US center during the 1999-2000 (Year 1) and 2000-2001 (Year 2) influenza seasons. The intent-to-treat analysis set included a total of 786 children 6 through 24 months of age. Participants received two 0.25 mL doses of either Fluzone (N=525) or a placebo (N=261). Among all randomized participants in both years, the mean age was 13.8 months; 52.5% were male, 50.8% were Caucasian, 42.0% were Black, and 7.2% were of other racial groups. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 8.
|Fluzone †||Placebo ‡||Fluzone vs. Placebo|
|Year||n §||N ¶||Rate(n/N)#||(95% CI)||n §||N ¶||Rate(n/N)#||(95% CI)||Relative Risk(95% CI)||Percent Relative Reduction Þ (95% CI)|
|Year 1ß||15||273||5.5||(3.1; 8.9)||22||138||15.9||(10.3; 23.1)||0.34 (0.18; 0.64)||66 (36; 82)|
|Year 2à||9||252||3.6||(1.6; 6.7)||4||123||3.3||(0.9; 8.1)||1.10 (0.34; 3.50)||-10 (-250; 66)|
14.2 Efficacy of Fluzone (Trivalent Influenza Vaccine) in Adults
A randomized, double-blind, placebo-controlled study was conducted in a single US center during the 2007-2008 influenza season. Participants received one dose of either Fluzone vaccine (N=813), an active comparator (N=814), or placebo (N=325). The intent-to-treat analysis set included 1138 healthy adults who received Fluzone or placebo. Participants were 18 through 49 years of age (mean age was 23.3 years); 63.3% were female, 83.1% were Caucasian, and 16.9% were of other racial/ethnic groups. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR).
Influenza-like illness was defined as an illness with at least 1 respiratory symptom (cough or nasal congestion) and at least 1 constitutional symptom (fever or feverishness, chills, or body aches). Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9.
|Laboratory- Confirmed Symptomatic Influenza||Fluzone ‡(N=813)§||Placebo ¶(N=325)§||Fluzone vs. Placebo|
|n #||Rate(%)Þ||(95% CI)||n #||Rate(%)Þ||(95% CI)||Relative Risk(95% CI)||Percent Relative Reduction ß(95% CI)|
|Positive culture||21||2.6||(1.6; 3.9)||31||9.5||(6.6; 13.3)||0.27 (0.16; 0.46)||73 (54; 84)|
|Positive PCR||28||3.4||(2.3; 4.9)||35||10.8||(7.6; 14.7)||0.32 (0.20; 0.52)||68 (48; 80)|
|Positive culture, positive PCR, or both||28||3.4||(2.3; 4.9)||35||10.8||(7.6; 14.7)||0.32 (0.20; 0.52)||68 (48; 80)|
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