Abstract
ABSTRACTThis phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y–tetanus toxoid conjugate vaccine (Hib-MenCY-TT) with human rotavirus vaccine (HRV), hepatitis A vaccine (HAV) and 13-valent pneumococcal conjugate vaccine (PCV13). We randomized 600 infants (1:1) to receive 4 doses of Hib-MenCY-TT at 2, 4, 6 and 12–15 months of age or 3 doses of Hib vaccine conjugated to N. meningitidis outer membrane protein complex (Hib-OMP) at 2, 4 and 12–15 months of age. All infants received HRV at 2 and 4 months of age, PCV13 at 2, 4, 6 and 12–15 months of age, HAV at 12–15 and 18–21 months of age, and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months of age. We measured immune responses against HRV, HAV and Hib with enzyme-linked immunosorbent assays, and against MenC/MenY with serum bactericidal assays using human complement. The 4-dose vaccination series with Hib-MenCY-TT induced a robust immune response against Hib, which was non-inferior to that induced by a 3-dose vaccination series with Hib-OMP, and against MenC and MenY. Hib-MenCY-TT did not interfere with immune responses to concomitantly administered HRV, PCV13 and HAV. We did not identify any safety concern. In conclusion, we showed that 4-dose vaccination series with Hib-MenCY-TT during infancy did not interfere with immune responses of co-administered HRV, PCV13 and HAV, induced robust immune responses against Hib, MenC and MenY, and had a clinically acceptable safety profile.
Highlights
Following the introduction of Haemophilus influenzae type b (Hib) and pneumococcal conjugate vaccines in the routine infant immunization schedules and the recommendation to vaccinate preteens and adolescents with meningococcal conjugate vaccines in the United States (US), the incidence of bacterial meningitis has declined in the past 20 years.[1-4]
This study evaluated the immunogenicity and safety of the Hib-MenCY-tetanus toxoid (TT) vaccine co-administered with human rotavirus vaccine (HRV), PCV13 and hepatitis A vaccine (HAV) vaccines during infancy
Four doses of the HibMenCY-TT vaccine induced a robust immune response against polyribosylribitol phosphate (PRP), which was non-inferior to that induced by 3 doses of the Hib-OMP vaccine, and against MenC and MenY
Summary
Following the introduction of Haemophilus influenzae type b (Hib) and pneumococcal conjugate vaccines in the routine infant immunization schedules and the recommendation to vaccinate preteens and adolescents with meningococcal conjugate vaccines in the United States (US), the incidence of bacterial meningitis has declined in the past 20 years.[1-4]. The combined Hib, MenC and MenY tetanus toxoid (TT) conjugate vaccine (Hib-MenCY-TT, MenHibrix, GSK) was developed to protect infants against invasive diseases caused by Hib, MenC and MenY without increasing the number of injections in the US immunization schedule and was approved by the Food and Drug Administration in 2012 for use in infants as a 4-dose vaccination series.[6,7]. A previous phase III study showed that a 3-dose primary vaccination series with Hib-MenCY-TT in infants at 2, 4 and 6 months of age followed by a 4th dose at 12–15 months of age had a comparable immunogenicity profile to licensed Hib vaccines, induced a robust immune response against MenC and MenY, and had a clinically acceptable safety profile.[7,8]. This study evaluated the immunogenicity and safety of coadministered Hib-MenCY-TT with the remaining routinely administered concomitant vaccines (human rotavirus vaccine [HRV; Rotarix, GSK] and hepatitis A vaccine [HAV; Havrix, GSK]) and with the currently available 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar, Pfizer) The combined Hib, MenC and MenY tetanus toxoid (TT) conjugate vaccine (Hib-MenCY-TT, MenHibrix, GSK) was developed to protect infants against invasive diseases caused by Hib, MenC and MenY without increasing the number of injections in the US immunization schedule and was approved by the Food and Drug Administration in 2012 for use in infants as a 4-dose vaccination series.[6,7] A previous phase III study showed that a 3-dose primary vaccination series with Hib-MenCY-TT in infants at 2, 4 and 6 months of age followed by a 4th dose at 12–15 months of age had a comparable immunogenicity profile to licensed Hib vaccines, induced a robust immune response against MenC and MenY, and had a clinically acceptable safety profile.[7,8] In addition, Hib-MenCY-TT did not appear to interfere with the immune responses of the concomitantly administered diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine (DTaP-HBV-IPV), 7-valent pneumococcal conjugate vaccine,[9,10] mumps-measles-rubella vaccine, and varicella virus vaccine.[11]
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