Vaccine Information: VAQTA (Page 3 of 5)

14.2 Other Clinical Studies

The efficacy of VAQTA in other age groups was based upon immunogenicity measured 4 to 6 weeks following vaccination. VAQTA was found to be immunogenic in all age groups.

Children — 12 through 23 Months of Age

In a clinical trial, children 12 through 23 months of age were randomized to receive the first dose of VAQTA with or without M-M-R II and VARIVAX (N=617) and the second dose of VAQTA with or without Tripedia and optionally either oral poliovirus vaccine (no longer licensed in the US) or IPOL (N=555). The race distribution of study subjects who received at least one dose of VAQTA was as follows: 56.7% Caucasian; 17.5% Hispanic-American; 14.3% African-American; 7.0% Native American; 3.4% other; 0.8% Oriental; 0.2% Asian; and 0.2% Indian. The distribution of subjects by gender was 53.6% male and 46.4% female. In the analysis population, there were 471 initially seronegative children 12 through 23 months of age, who received the first dose of VAQTA with (N=237) or without (N=234) M-M-R II and VARIVAX of whom 96% (95% CI: 93.7%, 97.5%) seroconverted (defined as having an anti-HAV titer ≥10 mIU/mL) post dose 1 with an anti-HAV geometric mean titer (GMT) of 48 mIU/mL (95% CI: 44.7, 51.6). There were 343 children in the analysis population who received the second dose of VAQTA with (N=168) or without (N=175) Tripedia and optional oral poliovirus vaccine or IPOL of whom 100% (95% CI: 99.3%, 100%) seroconverted post dose 2 with an anti-HAV GMT of 6920 mIU/mL (95% CI: 6136, 7801). Of children who received only VAQTA at both visits, 100% (n=97) seroconverted after the second dose of VAQTA.

In a clinical trial involving 653 healthy children 12 to 15 months of age, 330 were randomized to receive VAQTA, ProQuad, and pneumococcal 7-valent conjugate vaccine concomitantly, and 323 were randomized to receive ProQuad and pneumococcal 7-valent conjugate vaccine concomitantly followed by VAQTA 6 weeks later. The race distribution of the study subjects was as follows: 60.3% Caucasian; 21.6% African-American; 9.5% Hispanic-American; 7.2% other; 1.1% Asian/Pacific; and 0.3% Native American. The distribution of subjects by gender was 50.7% male and 49.3% female. In the analysis population, the seropositivity rate for hepatitis A antibody (defined as the percent of subjects with an anti-HAV titer ≥10 mIU/mL) was 100% (n=182; 95% CI: 98.0%, 100%) post dose 2 with an anti-HAV GMT of 4977 mIU/mL (95% CI: 4068, 6089) when VAQTA was given with ProQuad and pneumococcal 7-valent conjugate vaccine and 99.4% (n=159, 95% CI: 96.5%, 100%) post dose 2 with an anti-HAV GMT of 6123 mIU/mL (95% CI: 4826, 7770) when VAQTA alone was given. These seropositivity rates were similar whether VAQTA was administered with or without ProQuad and pneumococcal 7-valent conjugate vaccine.

In an open, multicenter, randomized study involving 617 children 15 months of age, 306 were randomized to receive VAQTA with or without PedvaxHIB and INFANRIX, and 311 were randomized to receive VAQTA with or without PedvaxHIB. The race distribution of the study subjects was as follows: 63.9% Caucasian; 17.5% Hispanic-American; 14.7% Black; 2.6% other; and 1.3% Asian. The distribution of subjects by gender was 54.0% male and 46.0% female. The seropositivity rate for hepatitis A antibody (defined as the percent of subjects with an anti-HAV titer ≥ 10 mIU/mL) 4 weeks post dose 2 was 100% (n=208, 95% CI: 98.2%, 100.0%) in those who received VAQTA concomitantly with PedvaxHIB and INFANRIX or concomitantly with PedvaxHIB. In those subjects who received VAQTA alone, the seropositivity rate for hepatitis A antibody was 100% (n=183, 95% CI: 98.0%, 100.0%), regardless of baseline hepatitis A serostatus. Overall, the anti-HAV GMT in the concomitant groups was 3616.5 mIU/mL (95% CI: 3084.5, 4240.2). The anti-HAV GMT in the nonconcomitant groups was 4712.6 mIU/mL (95% CI: 3996.8, 5556.8). Comparable responses were observed in both the initially seronegative and seropositive subjects.

In three combined clinical studies 1022 initially seronegative subjects received 2 doses of VAQTA alone or concomitantly with other vaccines. Of the seronegative subjects, 99.9% achieved an anti-HAV titer ≥10 mIU/mL (95% CI: 99.5%, 100%) and an anti-HAV GMT of 5392.1 mIU/mL (95% CI: 4996.5, 5819.0) 4 weeks following dose 2 of VAQTA.

Children/Adolescents — 2 Years through 18 Years of Age

Immunogenicity data were combined from eleven randomized clinical studies in children and adolescents 2 through 18 years of age who received VAQTA (25U/0.5 mL). These included administration of VAQTA in varying doses and regimens (N=404 received 25U/0.5 mL), the Monroe Efficacy Study (N=973), and comparison studies for process and formulation changes (N=1238). The race distribution of the study subjects who received at least one dose of VAQTA in these studies was as follows: 84.8% Caucasian; 10.6% American Indian; 2.3% African-American; 1.5% Hispanic-American; 0.6% other; 0.2% Oriental. The distribution of subjects by gender was 51.2% male and 48.8% female. The proportions of subjects who seroconverted 4 weeks after the first and second doses administered 6 months apart were 97% (n=1230; 95% CI: 96%, 98%) and 100% (n=1057; 95% CI: 99.5%, 100%) of subjects with anti-HAV GMTs of 43 mIU/mL (95% CI: 40, 45) and 10,077 mIU/mL (95% CI: 9394, 10,810), respectively.

Adults — 19 Years of Age and Older

Immunogenicity data were combined from five randomized clinical studies in adults 19 years of age and older who received VAQTA (50U/1-mL). One single-blind study evaluated doses of VAQTA with varying amounts of viral antigen and/or alum content in healthy adults ≥170 pounds and ≥30 years of age (N=208 adults administered 50U/1-mL dose). One open-label study evaluated VAQTA given with immune globulin or alone (N=164 adults who received VAQTA alone). A third study was single-blind and evaluated 3 different lots of VAQTA (N=1112). The fourth study was single-blind and evaluated doses of VAQTA with varying amounts of viral antigen in healthy adults ≥170 pounds and ≥30 years of age (N=159 adults administered the 50U/1-mL dose). The fifth study was an open-label study to evaluate various regimens for time of administration of the booster dose of VAQTA (6, 12, and 18 months post dose 1, N=354). The race distribution of the study subjects who received at least one dose of VAQTA in these studies was as follows: 93.2% Caucasian; 2.5% African-American; 2.1% Hispanic-American; 1.4% Oriental; 0.5% other; 0.3% American Indian. The distribution of subjects by gender was 44.8% male and 55.2% female. The proportion of subjects who seroconverted 4 weeks after the first and second doses administered 6 months apart was 95% (n=1411; 95% CI: 94%, 96%) and 99.9% (n=1244; 95% CI: 99.4%, 100%) with GMTs of 37 mIU/mL (95% CI: 35, 38) and 6013 mIU/mL (95% CI: 5592, 6467), respectively. Furthermore, at 2 weeks postvaccination, 69.2% (n=744; 95% CI: 65.7%, 72.5%) of adults seroconverted with an anti-HAV GMT of 16 mIU/mL after a single dose of VAQTA.

14.3 Timing of Booster Dose Administration

Children/Adolescents — 2 through 18 Years of Age

In the Monroe Efficacy Study, children were administered a second dose of VAQTA (25U/0.5 mL) 6, 12, or 18 months following the initial dose. For subjects who received both doses of VAQTA, the GMTs and proportions of subjects who seroconverted 4 weeks after the booster dose administered 6, 12, and 18 months after the first dose are presented in Table 9.

Table 9: Children/Adolescents from the Monroe Efficacy Study Seroconversion Rates (%) and Geometric Mean Titers (GMT) for Cohorts of Initially Seronegative Vaccinees at the Time of the Booster(25U) and 4 Weeks Later
Months Following Initial 25U Dose Cohort * (n=960)0 and 6 Months Cohort * (n=35)0 and 12 Months Cohort * (n=39)0 and 18 Months
Seroconversion RateGMT (mIU/mL) (95% CI)
*
Blood samples were taken at prebooster and postbooster time points.
6 97%107 (98, 117)
7 100%10433 (9681, 11243)
12 91%48 (33, 71)
13 100%12308 (9337, 16226)
18 90%50 (28, 89)
19 100%9591 (7613, 12082)

Adults — 19 years of age and older

Among the 5 randomized clinical studies in adults 19 years of age and older described in Section 14.2, there were additional data in which a booster dose of VAQTA (50U/1-mL) was administered 12 or 18 months after the first dose. For subjects in these studies who received both doses of VAQTA, the proportions who seroconverted 4 weeks after the booster dose administered 6, 12, and 18 months after the first dose were 100% of 1201 subjects, 98% of 91 subjects, and 100% of 84 subjects, respectively. GMTs in mIU/mL one month after the subjects received the booster dose at 6, 12, or 18 months after the primary dose were 5987 mIU/mL (95% CI: 5561, 6445), 4896 mIU/mL (95% CI: 3589, 6679), and 6043 mIU/mL (95% CI: 4687, 7793), respectively.

14.4 Duration of Immune Response

In follow-up of subjects in The Monroe Efficacy Study, in children (≥2 years of age) and adolescents who received two doses (25U) of VAQTA, detectable levels of anti-HAV antibodies (≥10 mIU/mL) were present in 100% of subjects for at least 10 years postvaccination. In subjects who received VAQTA at 0 and 6 months, the GMT was 819 mIU/mL (n=175) at 2.5 to 3.5 years and 505 mIU/mL (n=174) at 5 to 6 years, and 574 mIU/mL (n=114) at 10 years postvaccination. In subjects who received VAQTA at 0 and 12 months, the GMT was 2224 mIU/mL (n=49) at 2.5 to 3.5 years, 1191 mIU/mL (n=47) at 5 to 6 years, and 1005 mIU/mL (n=36) at 10 years postvaccination. In subjects who received VAQTA at 0 and 18 months, the GMT was 2501 mIU/mL (n=53) at 2.5 to 3.5 years, 1614 mIU/mL (n=56) at 5 to 6 years, and 1507 mIU/mL (n=41) at 10 years postvaccination.

In adults that were administered VAQTA at 0 and 6 months, the hepatitis A antibody response to date has been shown to persist at least 6 years. Detectable levels of anti-HAV antibodies (≥10 mIU/mL) were present in 100% (378/378) of subjects with a GMT of 1734 mIU/mL at 1 year, 99.2% (252/254) of subjects with a GMT of 687 mIU/mL at 2 to 3 years, 99.1% (219/221) of subjects with a GMT of 605 mIU/mL at 4 years, and 99.4% (170/171) of subjects with a GMT of 684 mIU/mL at 6 years postvaccination.

The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.