Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
Age
0–0
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy infants 2 months of age.
Infants with at least 37 weeks of gestation at delivery.
Signed informed consent from parent or guardian.
Able to attend the scheduled visits and to comply with the study procedure.
Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.
You may not be if
Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
Known or suspected hypersensitivity to any component of the study vaccine to be administered.
Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
Known HIV-positive mother.
Personal or immediate family history of congenital immune deficiency.
Developmental delay or neurologic disorders.
Chronic medical, congenital, developmental or surgical disease.
Participation in any other experimental vaccine trial.
Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine
