Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants

Launched by PT BIO FARMA · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called DTwP-Hepatitis B-Hib-IPV (Bio Farma) to see how safe it is and how well it can protect infants from certain diseases. The trial will involve infants aged 6 to 11 weeks who were born after 37 weeks of pregnancy and weighed more than 2.5 kg at birth. To participate, parents must understand the study and give their consent. However, infants with moderate or severe illnesses, allergies to vaccine components, or certain medical histories will not be eligible.

During the trial, participants will receive the vaccine and be monitored for any side effects for seven days after each dose. The goal is to ensure the vaccine is safe and check how well it can protect infants from diseases like diphtheria, tetanus, pertussis, Hib, and hepatitis B. This is an important step in developing vaccines that can help keep our children healthy. If you have a baby in the eligible age range and are interested in participating, please talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Infant 6-11 weeks of age.
• • 2. Infant born after 37-42 weeks of pregnancy.
• • 3. Infant weighing more than 2.5 kg at birth.
• • 4. Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.
• • 5. Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.
• Exclusion Criteria:
• • 1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
• • 2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).
• • 3. Known history of allergy to any component of the vaccines.
• • 4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• • 5. Known history of congenital or acquired immunodeficiency (including HIV infection).
• • 6. Child who has received in the previous 4 weeks of a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks).
• • 7. Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.
• • 8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• • 9. Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.