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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT03445416 -
Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men
|
N/A | |
Completed |
NCT01949857 -
The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
|
Phase 4 | |
Completed |
NCT00313950 -
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
|
Phase 4 | |
Completed |
NCT00139139 -
A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A
|
N/A | |
Completed |
NCT00197171 -
Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
|
Phase 3 | |
Completed |
NCT03312699 -
Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort
|
Phase 1 | |
Completed |
NCT03855176 -
Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients
|
Phase 4 | |
Completed |
NCT00197002 -
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
|
Phase 3 | |
Withdrawn |
NCT02605538 -
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively
|
N/A | |
Completed |
NCT04638335 -
What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years
|
||
Completed |
NCT00197015 -
Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
|
Phase 3 | |
Active, not recruiting |
NCT06058416 -
Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old
|
Phase 4 | |
Completed |
NCT01453348 -
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
|
Phase 3 | |
Completed |
NCT01865968 -
Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults
|
Phase 4 | |
Completed |
NCT02002065 -
The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children
|
N/A | |
Terminated |
NCT00119743 -
A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
|
Phase 3 | |
Completed |
NCT01000324 -
Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult
|
Phase 4 | |
Completed |
NCT00289731 -
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
|
Phase 4 | |
Completed |
NCT02300792 -
The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A
|
Phase 2 | |
Completed |
NCT02601040 -
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
|
Phase 4 |