Hepatitis A Clinical Trial
Official title:
Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children
Infants born to immune mothers and therefore having passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules. We found that when vaccination is begun at or after 12 months of age, there was no difference in the immune response to the vaccine between infants born to immune vs. susceptible mothers.
Status | Completed |
Enrollment | 248 |
Est. completion date | June 2001 |
Est. primary completion date | June 2001 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 6 Months |
Eligibility |
Inclusion Criteria:term infant with normal growth and development, considered to be
healthy at age 6 months; written informed consent by parent/guardian - Exclusion Criteria:received or expected to receive immune globulin or blood/blood products while enrolled; received or expected to receive immunosuppressive therapy within 30 days of vaccination or has immune deficiency; currently enrolled in another vaccine trial; progressive or unstable neurological disorder |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Alaska Native Medical Center | Anchorage | Alaska |
United States | Anchorage Neighborhood Health Center | Anchorage | Alaska |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | Alaska Native Medical Center, GlaxoSmithKline |
United States,
Bell BP, Negus S, Fiore AE, Plotnik J, Dhotre KB, Williams J, Shapiro CN, McMahon BJ. Immunogenicity of an inactivated hepatitis A vaccine in infants and young children. Pediatr Infect Dis J. 2007 Feb;26(2):116-22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | concentration of antibody to hepatitis A virus | Sera obtained at time of first hepatitis A vaccine dose (baseline) and 1, 7, and 12 months thereafter | baseline and 1, 7, and 12 months post vax | No |
Secondary | reported side effects and adverse events | at time of each vaccine dose, parent was given a diary card on which to record systemic and injection site signs and symptoms observed on day of vaccination and subsequent 3 days. | day of vaccination and 3 days thereafter | Yes |
Secondary | antibodies to routine childhood vaccinations | in a sample of study subjects from each group, blood drawn at age 13 months was tested for response to routine vaccinations. | age 13 months | No |
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