Not yet recruitingNCT06690515Updated Nov 15, 2024

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

A Phase 1/2 interventional study of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A and DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B in Vaccine Adverse Reaction and Vaccine Reaction, sponsored by PT Bio Farma. Not yet recruiting at 3 sites in Indonesia. Open to participants aged 6 Weeks to 11 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by PT Bio Farma · Phase 1/2, Interventional, and Prevention

From the registry’s dates

Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 465
Allocation: Randomized
Ages: 6 Weeks to 11 Weeks
Sex: All

Study summary

This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.

Read the detailed description

This trial is open label, comparative, randomized, phase I/II study. For phase I, approximately 75 subjects will be recruited and will seamlessly continue to phase II recruiting 390 subject, in total 465 subjects.

In this study, DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine will be compared to an active control (Registered DTwP-Hepatitis B-Hib Vaccine and Registered Inactivated Polio Vaccine). There are 2 formulas of DTwP-Hepatitis B-Hib-IPV Vaccine which will be used in the study. The regimen of the vaccine is 0,5 ml injected three-dose regimen with 28 days interval between doses. On the other hand, the control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml Inactivated Bio Farma vaccine injected in three-dose regimen with 28 days interval between doses.

The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. Clinical trial of phase II can be conducted after safety observation within 28 days after the third dose in phase I. Three hundred and ninety (390) healthy subjects aged 6-11 weeks of age will be recruited in Phase II trial.

Conditions studied

Vaccine Adverse Reaction
Vaccine Reaction

In context

Lead sponsor

PT Bio Farma is the lead sponsor of 46 studies on the registry; 6 are open to participants now.

Browse PT Bio Farma studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Weeks to 11 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Infant 6-11 weeks of age.
Infant born after 37-42 weeks of pregnancy.
Infant weighing more than 2.5 kg at birth.
Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.
Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.

Exclusion criteria

Exclusion Criteria:

Child concomitantly enrolled or scheduled to be enrolled in another trial.
Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).
Known history of allergy to any component of the vaccines.
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
Known history of congenital or acquired immunodeficiency (including HIV infection).
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).
Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.
Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 465 participants (estimated)

Study arms

Experimental
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A
0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses
Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A
Experimental
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B
0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses.
Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B
Active comparator
Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ®
0,5 ml of DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® injected three-dose regimen with 28 days interval between doses.
Biological: Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®

Interventions

BiologicalDTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A
0,5 ml DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses. Vaccine is injected intramuscularly in left anterolateral thigh.
BiologicalDTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B
0,5 ml injected of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B three-dose regimen with 28 days interval between doses. Injected intramuscularly in left anterolateral thigh.
BiologicalRegistered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®
The control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml IPV (Sinovac)® injected in three-dose regimen with 28 days interval between doses. Registered DTwP-Hepatitis B-Hib Vaccine are injected intramuscularly into the left antero-lateral thigh region. IPV (Sinovac)® vaccine are injected intramuscularly into the right mid-lateral thigh region

What researchers measure

Primary outcomes

Phase I: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
Time frame: From enrollment to 7 days after first dose
Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
Protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
Time frame: From enrollment up to 28 days after third dose

Secondary outcomes

Phase I: Safety of the vaccine within 28 days after last dose
Number and percentage of solicited and unsolicited adverse events within 28 days after each dose
Time frame: From enrollment to 28 days after each dose
Phase I: Safety of the vaccine within 6 months after last dose
Number and percentage of subjects with serious adverse events until 6 months after last dose
Time frame: From enrollment up to 6 months after the last dose
Phase I: Comparison of safety within 28 days after each dose between vaccines and active control
Comparison of number and percentage of subjects with adverse events between vaccine and control group within 28 days after each dose
Time frame: From enrollment to 28 days after each dose
Phase I: Comparison of safety until 6 months after last dose between vaccines and active control
Comparison of number and percentage of subjects with serious adverse events between vaccine and control group until 6 months after last dose
Time frame: From enrollment to 6 months after last dose
Phase I: Routine laboratory evaluation that probably related to the vaccination
Any deviation from routine laboratory evaluation that probably related to the dosing 7 days after first dose.
Time frame: From enrollment to 7 days after first dose
Phase I: Serological response to diphteria toxoid and tetanus toxoid
Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer ≥ 0.01 IU/ml, ≥ 0.1 IU/ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive.
Time frame: 28 days after the last dose immunization
Phase I: Serological response to the pertussis component (agglutinins)
GMT, percentage of infants with titer ≥ 40, ≥ 80 and ≥ 320 (1/dil.), percentage of infants with increasing antibody titer ≥ 4 times
Time frame: 28 days after the last dose immunization
Phase I: Geometric mean of anti-HbsAg
Percentage of infants with titer ≥ 10mIU/ml, percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive.
Time frame: 28 days after the last dose immunization
Phase I: Serological response to Hib/PRP
GMT, percentage of infants with titer ≥ 1 μg /ml; ≥ 0.15 μg /ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after the last dose immunization
Phase I: Serological response to polio type 1, 2, and 3 (humoral immunity)
GMT, percentage of infants with titer ≥ 8, percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after the last dose immunization
Phase II: Serological response to diphtheria toxoid, tetanus toxoid
GMT, percentage of infants with titer ≥ 0.01 IU/ml, ≥ 0.1 IU/ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after the last dose immunization
Phase II: Serological response to the pertussis component (agglutinins)
GMT, percentage of infants with titer ≥ 40, ≥ 80 and ≥ 320 (1/dil.), percentage of infants with increasing antibody titer ≥ 4 times
Time frame: 28 days after the last dose immunization
Phase II: Geometric mean of anti-HbsAg
percentage of infants with titer ≥ 10mIU/ml, percentage of infants with increasing antibody titer ≥ 4 times and/ or percentage of infants with transition of seronegative to seropositive.
Time frame: 28 days after the last dose immunization
Phase II: Serological response to Hib/PRP
GMT, percentage of infants with titer ≥ 1 μg /ml; ≥ 0.15 μg /ml percentage of infants with increasing antibody titer ≥ 4 times and/or percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after the last dose immunization
Phase II: Serological response to polio type 1, 2, and 3 (humoral immunity)
GMT, percentage of infants with titer ≥ 8, percentage of infants with transition of seronegative to seropositive
Time frame: 28 days after the last dose immunization
Phase II: Safety of vaccine within 30 minutes after immunization
Local reaction and systemic events occurring within 30 minutes after immunization
Time frame: 30 minutes after immunization
Phase II: Safety of vaccine within 7 days after immunization
Local reaction and systemic events occurring within 7 days after immunization
Time frame: Within 7 days after immunization
Phase II: Safety of vaccine after 7 days to 28 days following the vaccination
Local reaction and systemic events occurring after the 7 days to 28 days following the vaccination
Time frame: From 7 days to 28 days following the vaccination

Study locations

3 sites

Garuda Primary Health Centre
Bandung, West Java, Indonesia
Ibrahim Adjie Priamry Health Centre
Bandung, West Java, Indonesia
Puter Primary Health Centre
Bandung, West Java, Indonesia

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2025; primary completion for Oct 2025, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 13, 2024
First posted: Nov 15, 2024
StartEst.: Mar 1, 2025
Primary completionEst.: Oct 31, 2025
CompletionEst.: Sep 30, 2026
Last update: Nov 15, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06690515
Lead sponsor: PT Bio Farma
Collaborators: Universitas Padjadjaran
Responsible party: Sponsor
First posted: Nov 15, 2024
Start date: Mar 1, 2025 (estimated)
Primary completion: Oct 31, 2025 (estimated)
Completion: Sep 30, 2026 (estimated)
Last update: Nov 15, 2024

Study contacts

Rini Mulia Sari, MD

Contact

rini.mulia@biofarma.co.id

+622033755 ext. 14102

Mita Puspita, MD

Contact

mita.puspita@biofarma.co.id

+622033755 ext. 5045

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

PT Bio Farma →

Start the discussion