Healthy infants who had not received DTwP-HB-Hib vaccinations
Conditions
Interventions
Intervention: DTwP-HB-Hib vaccination at eight-weeks interval
Control: DTwP-HB-Hib vaccination at four-weeks interval
Sponsors
Universitas Sriwijaya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy infants aged two months who had not previously received DTP vaccination, and whose parents consented to participate in the study by singing informed consent form.
Exclusion criteria
Exclusion criteria: infants who have already received diphtheria and those with contraindications following the administration of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (DTwP-HepB-Hib) vaccines. The dropout criteria were infants who failed to attend scheduled appointments, declined to complete the study, relocated from Palembang during the study, switched to the DtaP vaccine, experienced a severe adverse reaction to the vaccine, died during the study, or had insufficient or inadequate blood samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-diphtheria toxoid immunoglobulin G (IgG) antibody levels measured after three doses of DTwP-HB-Hib vaccinations | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects following the administration of the vaccine (local pain, local edema, fever, seizure) | — |
Countries
Asia(except Japan)
Contacts
Public ContactAriesti Karmila
Faculty of Medicine, Universitas Sriwijaya Department of Child Health
Outcome results
None listed