Vaccine Information: VAQTA (Page 4 of 5)

14.5 Concomitant Administration of VAQTA and Immune Globulin

The concurrent use of VAQTA (50U) and immune globulin (IG, 0.06 mL/kg) was evaluated in an open-label, randomized clinical study involving 294 healthy adults 18 to 39 years of age. Adults were randomized to receive 2 doses of VAQTA 24 weeks apart (N=129), the first dose of VAQTA concomitant with a dose of IG followed by the second dose of VAQTA alone 24 weeks later (N=135), or IG alone (N=30). The race distribution of the study subjects who received at least one dose of VAQTA or IG in this study was as follows: 92.3% Caucasian; 4.0% Hispanic-American; 3.0% African-American; 0.3% Native American; 0.3% Asian/Pacific. The distribution of subjects by gender was 28.7% male and 71.3% female. Table 10 provides seroconversion rates and GMTs at 4 and 24 weeks after the first dose in each treatment group and at one month after a booster dose of VAQTA (administered at 24 weeks) [see Drug Interactions (7.2)].

Table 10: Seroconversion Rates (%) and Geometric Mean Titers (GMT) After Vaccination with VAQTA Plus IG, VAQTA Alone, and IG Alone
VAQTA plus IG VAQTA IG
Weeks Seroconversion RateGMT (mIU/mL) (95% CI)
N/A = Not Applicable.
*
The seroconversion rate and the GMT in the group receiving VAQTA alone were significantly higher than in the group receiving VAQTA plus IG (p=0.05, p<0.001, respectively).
Undetectable is defined as <10mIU/mL.
4 100%42 (39, 45)(n=129) 96%38 (33, 42)(n=135) 87%19 (15, 23)(n=30)
24 92%83 (65, 105)(n=125) 97%*137* (112, 169)(n=132) 0%Undetectable (n=28)
28 100%4872 (3716, 6388)(n=114) 100%6498 (5111, 8261)(n=128) N/A

14.6 Interchangeability of the Booster Dose

A randomized, double-blind clinical study in 537 healthy adults, 18 to 83 years of age, evaluated the immune response to a booster dose of VAQTA and HAVRIX given at 6 or 12 months following an initial dose of HAVRIX. Subjects were randomized to receive VAQTA (50U) as a booster dose 6 months (N=232) or 12 months (N=124) following an initial dose of HAVRIX or HAVRIX (1440 EL. U) as a booster dose 6 months (N=118) or 12 months (N=63) following an initial dose of HAVRIX. The race distribution of the study subjects who received the booster dose of VAQTA or HAVRIX in this study was as follows: 87.2% Caucasian; 8.0% African-American; 1.9% Hispanic-American; 1.3% Oriental; 0.9% Asian; 0.4% Indian; 0.4% other. The distribution of subjects by gender was 44.9% male and 55.1% female. When VAQTA was given as a booster dose following HAVRIX, the vaccine produced an adequate immune response (see Table 11) [see Dosage and Administration (2.1)].

Table 11: Seropositivity Rate, Booster Response Rate * and Geometric Mean Titer 4 Weeks Following a Booster Dose of VAQTA or HAVRIX Administered 6 to 12 Months After First Dose of HAVRIX
First Dose Booster Dose Seropositivity Rate Booster Response Rate * Geometric Mean Titer
*
Booster Response Rate is defined as greater than or equal to a tenfold rise from prebooster to postbooster titer and postbooster titer ≥100 mIU/mL.
Study conducted in adults 18 years of age and older.
HAVRIX1440 EL.U. VAQTA50 U 99.7% (n=313) 86.1% (n=310) 3272 (n=313)
HAVRIX1440 EL.U. HAVRIX1440 EL.U. 99.3% (n=151) 80.1% (n=151) 2423 (n=151)

14.7 Immune Response to Concomitantly Administered Vaccines

Clinical Studies of VAQTA with M-M-R II, VARIVAX, and Tripedia

In the clinical trial in which children 12 months of age received the first dose of VAQTA concomitantly with M-M-R II and VARIVAX described in Section 14.2, rates of seroprotection to hepatitis A were similar between the two groups who received VAQTA with or without M-M-R II and VARIVAX. Measles, mumps, and rubella immune responses were tested in 241 subjects, 263 subjects, and 270 subjects, respectively. Seropositivity rates were 98.8% [95% CI: 96.4%, 99.7%] for measles, 99.6% [95% CI: 97.9%, 100%] for mumps, and 100% [95% CI: 98.6%, 100%] for rubella, which were similar to observed historical rates (seropositivity rates 99% for all three antigens, with lower bound of the 95% CI >89%) following vaccination with a first dose of M-M-R II in this age group. Data from this study were insufficient to adequately assess the immune response to VARIVAX administered concomitantly with VAQTA. In this same study, the second dose of VAQTA at 18 months of age was given with or without Tripedia (DTaP). Seropositivity rates for diphtheria and tetanus were similar to those in historical controls. However, data from this study were insufficient to assess the pertussis response of DTaP when administered with VAQTA. Rates of seroprotection to hepatitis A were similar between the two groups who received VAQTA with or without M-M-R II and VARIVAX, and between the two groups who received VAQTA with or without DTaP.

Clinical Studies of VAQTA with ProQuad and Prevnar

In the clinical trial of concomitant use of VAQTA with ProQuad and pneumococcal 7-valent conjugate vaccine in children 12 to 15 months of age described in Section 14.2, the antibody GMTs for S. pneumoniae types 4, 6B, 9V, 14, 18C, 19F, and 23F 6 weeks after vaccination with pneumococcal 7-valent conjugate vaccine administered concomitantly with ProQuad and VAQTA were non-inferior as compared to GMTs observed in the group given pneumococcal 7-valent conjugate vaccine with ProQuad alone (the lower bounds of the 95% CI around the fold-difference for the 7 serotypes excluded 0.5). For the varicella component of ProQuad, in subjects with baseline antibody titers <1.25 gpELISA units/mL, the proportion with a titer ≥5 gpELISA units/mL 6 weeks after their first dose of ProQuad was non-inferior (defined as -10 percentage point change) when ProQuad was administered with VAQTA and pneumococcal 7-valent conjugate vaccine as compared to the proportion with a titer ≥5 gpELISA units/mL when ProQuad was administered with pneumococcal 7-valent conjugate vaccine alone (difference in seroprotection rate -5.1% [95% CI: -9.3, -1.4%]). Hepatitis A responses were similar when compared between the two groups who received VAQTA with or without ProQuad and pneumococcal 7-valent conjugate vaccine. Seroconversion rates and antibody titers for varicella and S. pneumoniae types 4, 6B, 9V, 14, 18C, 19F, and 23F were similar between groups at 6 weeks postvaccination.

Clinical Studies of VAQTA with INFANRIX and PedvaxHIB

In the clinical trial of concomitant administration of VAQTA with INFANRIX and PedvaxHIB in children 15 months of age, described in Section 14.2, when the first dose of VAQTA was administered concomitantly with either INFANRIX and PedvaxHIB or PedvaxHIB, there was no interference in immune response to hepatitis A as measured by seropositivity rates after dose 2 of VAQTA compared to administration of both doses of VAQTA alone. When dose 1 of VAQTA was administered concomitantly with either PedvaxHIB and INFANRIX or PedvaxHIB, there was no interference in immune response to Haemophilus influenzae b (as measured by the proportion of subjects who attained an anti-polyribosylribitol phosphate antibody titer >1.0 mcg/mL at 4 weeks after vaccination), compared to subjects receiving either PedvaxHIB and INFANRIX or PedvaxHIB. When VAQTA was administered concomitantly with INFANRIX and PedvaxHIB, there was no interference in immune responses at 4 weeks after vaccination to the pertussis antigens (PT, FHA, or pertactin, as measured by GMTs) and no interference in immune responses to diphtheria toxoid or tetanus toxoid (as measured by the proportion of subjects achieving an antibody titer >0.1 IU/mL) compared to administration of INFANRIX and PedvaxHIB.

Clinical Studies of VAQTA with Typhoid Vi Polysaccharide Vaccine and Yellow Fever Vaccine, Live Attenuated

In the clinical trial of concomitant use of VAQTA with typhoid Vi polysaccharide and yellow fever vaccines in adults 18-54 years of age described in Section 6.1, the antibody response rates for typhoid Vi polysaccharide and yellow fever were adequate when typhoid Vi polysaccharide and yellow fever vaccines were administered concomitantly with (N=80) and nonconcomitantly without VAQTA (N=80). The seropositivity rate for hepatitis A when VAQTA, typhoid Vi polysaccharide, and yellow fever vaccines were administered concomitantly was generally similar to when VAQTA was given alone [see Drug Interactions (7.1)].

Data are insufficient to assess the immune response to VAQTA and poliovirus vaccine when administered concomitantly.

16 HOW SUPPLIED/STORAGE AND HANDLING

VAQTA is available in single-dose vials and prefilled Luer-Lok® syringes.

Pediatric/Adolescent Formulations

25U/0.5 mL in single-dose vials and prefilled Luer-Lok® syringes.
NDC 0006-4831-41 – box of ten 0.5-mL single dose vials.
NDC 0006-4095-02 – carton of ten 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps.

Adult Formulations

50U/1-mL in single-dose vials and prefilled Luer-Lok® syringes.
NDC 0006-4841-00 – 1-mL single dose vial.
NDC 0006-4841-41 – box of ten 1-mL single dose vials.
NDC 0006-4096-02 – carton of ten 1-mL prefilled single-dose Luer-Lok® syringes with tip caps.

Store vaccine at 2-8°C (36-46°F).
DO NOT FREEZE since freezing destroys potency.

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