Prevention of pertussis, diphtheria, tetanus, poliomyelitis(polio), Hib infection, and hepatitis B
Conditions
Interventions
Study drug group
KD2-396 should be administered as follows: Administer 0.5 mL intramuscularly three doses at intervals of 27 to 56 days, followed by one 0.5 mL intramuscular dose 6 to 18 months after
Sponsors
Yamamoto Akihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Infants aged >=2 months and <7 months at the time of the first dose 2.Written informed consent provided by a legal representative
Exclusion criteria
Exclusion criteria: 1.History of pertussis, diphtheria, tetanus, poliomyelitis (polio), Hib infection, or hepatitis B (as reported by a legal representative) 2.Receipt of any vaccine against pertussis, diphtheria, tetanus, poliomyelitis (polio), or Hib infection 3.Receipt of hepatitis B vaccine and hepatitis B immune globulin to prevent vertical transmission 4.History of anaphylaxis due to components of the investigational products 5.Subjects with fibrodysplasia ossificans progressiva 6.Participants in another clinical trial and receipt of another investigational product within 120 days prior to the administration of the study drug 7.Receipt of a blood transfusion or a gamma globulin preparation within 90 days prior to the first dose of the study drug, or high-dose gamma globulin therapy (>=200 mg/kg) within 180 days prior to the first dose 8.Receipt of treatment* affecting immune function within 180 days prior to the first dose of the study drug *Radiation therapy, immunosuppressants (topical drugs permitted), immunosuppressive therapy, antirheumatic drugs, adrenocorticotropic hormone agents, and adrenocortical steroid preparations (defined as a treatment for>=14 consecutive days at a prednisolone-equivalent dose of >=2 mg/kg/day for those weighing = 20 mg/day for those weighing >= 10 kg; topical drugs are permitted) 9.Others: Subjects deemed inappropriate for participation by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Difference in the proportion of subjects with antibody titers at or above the protective level against hepatitis B virus surface antigen (HBsAg) between the study drug group and the control drug group -Difference in the proportion of subjects with antibody titers at or above the protective level (long-term protective level for PRP) against PT, FHA, diphtheria toxin, tetanus toxoid, attenuated poliovirus types 1, 2, and 3, and PRP between the study drug group and the control drug group | — |
Secondary
| Measure | Time frame |
|---|---|
| -Proportion of subjects with antibody titers against HBsAg at or above the protective level in the study drug group and in the control drug group -Proportion of subjects with antibody titers at or above the protective level (including long-term protective level for PRP) against PT, FHA, diphtheria toxin, tetanus toxoid, attenuated poliovirus types 1, 2, and 3, and PRP in the study drug group and in the control drug group -Geometric mean antibody titer against HBsAg in the study drug group and in the control drug group -Geometric mean antibody titers against PT, FHA, diphtheria toxin, tetanus toxoid, and PRP in the study drug group and in the control drug group -Mean antibody titers (log2) against attenuated poliovirus types 1, 2, and 3 in the study drug group and in the control drug group | — |
Contacts
Public ContactMasatoshi Yamashita
KM Biologics Co., Ltd.
Outcome results
None listed