Immunogenicity and reactogenicity of the human rotavirus vaccine, RIX4414 oral suspension, when co-administered with routine childhood vaccines in Chinese infants

Hum Vaccin Immunother. 2016 Mar 3;12(3):785-93. doi: 10.1080/21645515.2015.1085143.

Abstract

This study evaluated the immunogenicity of the human rotavirus (RV) vaccine (RIX4414) when co-administered with routine childhood vaccines in Chinese infants (NCT01171963). Healthy infants aged 6-16 weeks received 2 doses of either RIX4414 or placebo according to a 0, 1-month schedule. Infants received routine diphtheria-tetanus-acellular pertussis (DTPa) and oral poliovirus (OPV) vaccines either separately from or concomitantly with RIX4414/placebo (separate and co-administration cohorts, respectively). Anti-RV IgA seroconversion rates (one month post-dose-2) and seropositivity rates (at one year of age) were measured using ELISA. Immune responses against the DTPa and OPV antigens were measured one month post-DTPa dose-3 in the co-administration cohort. Solicited local and general symptoms were recorded for 8-days post-vaccination (total cohort). The according-to-protocol immunogenicity population included 511 infants in the separate cohort and 275 in the co-administration cohort. One month post-RIX4414 dose-2, anti-RV IgA seroconversion rates were 74.7% (95% confidence interval [CI]: 68.9-79.9) and 64.2% (95% CI: 55.4-72.3) in the separate and co-administration cohorts; seropositivity rates at one year of age were 71.5% (95% CI: 65.5-77.1) and 50.0% (95% CI: 40.9-59.1), respectively. One month post-DTPa dose-3, all infants in the co-administration cohort were seroprotected against diphtheria and tetanus, and seropositive for pertussis toxoid, pertactin and filamentous haemaglutinin. Two months post-OPV dose-3, seroprotection rates against anti-poliovirus types 1, 2 and 3 were >99% in the co-administration cohort. Reactogenicity profiles were similar in both cohorts. RIX4414 was immunogenic and well-tolerated in Chinese infants and did not appear to interfere with the immunogenicity and reactogenicity of co-administered routine childhood vaccines.

Keywords: China; DTPa; OPV; RIX4414; immunogenicity; reactogenicity; rotavirus; routine childhood vaccines.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antibodies, Bacterial / blood
  • Antibodies, Viral / blood
  • China
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / adverse effects*
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology*
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Immunization Schedule
  • Immunoglobulin A / blood
  • Infant
  • Male
  • Placebos / administration & dosage
  • Poliovirus Vaccines / administration & dosage
  • Poliovirus Vaccines / adverse effects*
  • Poliovirus Vaccines / immunology*
  • Rotavirus Vaccines / administration & dosage
  • Rotavirus Vaccines / adverse effects*
  • Rotavirus Vaccines / immunology*
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology

Substances

  • Antibodies, Bacterial
  • Antibodies, Viral
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Immunoglobulin A
  • Placebos
  • Poliovirus Vaccines
  • RIX4414 vaccine
  • Rotavirus Vaccines
  • Vaccines, Attenuated