Health TrialsbyHealthPanel

Study Interchangeability Hep-B Vaccine Administered at Birth Dose

ConditionsVaccination Adverse EventImmunogenicity, Vaccine
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-3
SponsorPT Bio Farma

About this trial

This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy, full term, newborn infants.

Infant born between 37-42 weeks of pregnancy.

Infant weigh between 2500 - 4000 gram at birth.

Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.

Disqualifiers

Infants concomitantly enrolled or scheduled to be enrolled in another trial.

Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).

Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.

Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).

Trial design

Design model

Parallel

Treatments tested in this trial

  • In-house Hepatitis B Vaccine

    Biological/Vaccine

    0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh

  • Registered Hepatitis B Vaccine

    Biological/Vaccine

    0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Hep B vaccine in-houseExperimental treatment 1 intervention
Group B: Registered Hep B vaccineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Protectivity of primary series In-House Recombinant Hepatitis B vaccine

Percentage of subjects with anti HBsAg \> 10mIU/ml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group

Time frame
28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine

Secondary outcomes

1

Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine

GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after birth dose Hep B vaccine

Time frame
28 days after administration of Hep B birth dose vaccine
2

Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine

GMT and percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive after completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine

Time frame
28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine
3

Safety of In-House Recombinant Hepatitis B vaccine

Percentage of subjects with solicited and unsolicited adverse events after each dose

Time frame
30 minutes, 7 days, 28 days after each dose
4

Serious Adverse Events

Percentage of infants with at least one serious adverse events

Time frame
28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PT Bio Farma

Lead sponsor

Faculty of Medicine Universitas Padjadjaran

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: