Vaqta

The Monroe Clinical Study

• Randomized, double-blind, placebo-controlled trial involving 1037 susceptible healthy children and adolescents 2 through 16 years old in a US community with recurrent outbreaks of hepatitis A.
• Children were randomly assigned to receive Vaqta (n=519) or placebo (n=518).
• Seroconversion was achieved in >99% of vaccine recipients within 4 weeks after vaccination.
• Clinical efficacy was based on confirmed cases of hepatitis A occurring ≥50 days after vaccination.
• Protective efficacy of a single dose of Vaqta was observed to be 100% with 21 cases of clinically confirmed hepatitis A occurring in the placebo group and none in the vaccine group (P <.001).
• ≥30 days after vaccination: 28 cases of clinically confirmed hepatitis A occurred in the placebo group while none occurred in the vaccine group.
• No cases of clinically confirmed hepatitis A occurred in the vaccine group after day 16.
• Booster dose was administered to a subset of vaccine recipients 6, 12, or 18 months after the primary dose.
• No cases of hepatitis A disease ≥50 days after vaccination have occurred; study participants were monitored for up to 9 years.

Child/Adolescent Data

• 11 randomized clinical studies in individuals 2 through 18 years of age who received Vaqta.
• 84.8% Caucasian;10.6% American Indian; 2.3% African-American; 1.5% Hispanic-American; 0.6% other; 0.2% Asian.
• 51.2% male and 48.8% female
• Proportions of participants 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).

Adult Data

• 5 randomized clinical studies in adults 19 years of age and older who received Vaqta.
• 93.2% Caucasian; 2.5% African-American; 2.1% Hispanic-American; 1.4% Asian; 0.5% other; 0.3% American Indian.
• 44.8% male and 55.2% female.
• Proportion of participants 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).

Concomitant Administration With Immune Globulin

• Open-label, randomized clinical study involving 294 healthy adults 18 to 39 years old.
• Participants were randomly assigned to receive 2 doses of Vaqta 24 weeks apart (n=129), the first dose of Vaqta  concomitant with a dose of IG followed by a second dose alone 24 weeks later (n=135) or IG alone (n=30).
• At 24 weeks, the seroconversion rate in the group receiving Vaqta alone was significantly higher than in the group receiving Vaqta plus IG (97% vs 92%; P =.05).

Interchangeability of the Booster Dose

• Randomized, double-blind study involving 537 adults (18-83 years old)
• Participants were randomly assigned to receive Vaqta as a booster dose 6 months (n=232) or 12 months (n=124) following an initial dose of Havrix or Havrix as a booster dose 6 months (n=118) or 12 months (n=63) following an initial dose of Havrix.
• When Vaqta was given as a booster dose following Havrix, the vaccine produced an adequate immune response.

Concomitant M-M-R II, Varivax, and Tripedia

• Rates of seroprotection to hepatitis A were similar between the 2 groups who received Vaqta with or without M-M-R II and Varivax.and between the 2 groups who received Vaqta with or without DTaP.
• Seropositivity rates were 98.8% for measles, 99.6% for mumps, and 100% for rubella, which were similar to observed historical rates.
• Seropositivity rates for diphtheria and tetanus were similar to those in historical controls.
• Data were insufficient to assess the pertussis response of DTaP when administered with Vaqta.
• Data were insufficient to adequately assess the immune response to Varivax administered concomitantly with Vaqta. 

Concomitant ProQuad and Prevnar

• Hepatitis A responses were similar when compared between the 2 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 post vaccination.

Concomitant Infanrix and PedvaxHIB

• When Vaqta was administered concomitantly with Infanrix and PedvaxHIB, no interference in immune responses at 4 weeks after vaccination to the pertussis antigens and no interference in immune responses diphtheria toxoid or tetanus toxoid was observed compared with administration of Infanrix and PedvaxHIB.

Concomitant Typhoid Vi Polysaccharide Vaccine and Yellow Fever Vaccine, Live Attenuated

• Antibody response rates for typhoid Vi polysaccharide and yellow fever were adequate when typhoid Vi polysaccharide and yellow fever vaccines were administered with or without Vaqta.
• 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.