Vaccine Adverse ReactionPhase 1/2NCT06690515
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 study testing DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B and Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® in people with Vaccine Adverse Reaction and Vaccine Reaction, run by PT Bio Farma at 3 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 weeksHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction, Vaccine Reaction
- What is being tested?
- DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B and Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 3 sitesIndonesia
- Study dates
- 1 Mar 2025to 30 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Garuda Primary Health Centre
Bandung, West Java
Ibrahim Adjie Priamry Health Centre
Bandung, West Java
Puter Primary Health Centre
Bandung, West Java
About this study
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
- Vaccine Adverse Reaction, Vaccine Reaction
- Being tested
- DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B, Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula ABiological
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.
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula BBiological
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.
Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®Biological
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
| Study group | Role | What they receive |
|---|---|---|
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A | Experimental | 0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses Receives: Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A |
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B | Experimental | 0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses. Receives: Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B |
| Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ® | Active comparator | 0,5 ml of DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® injected three-dose regimen with 28 days interval between doses. Receives: Biological: Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment up to 28 days after third dose
Secondary outcomes (18)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From 7 days to 28 days following the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 465 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690515
- Sponsor's protocol ID
- Hexa 010224
- Status last verified
- Oct 2024
- First submitted
- 13 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
- ClinicalTrials.gov ID
- NCT06690515
- Acronym / sponsor ID
- Hexa 010224
- Conditions
- Vaccine Adverse Reaction, Vaccine Reaction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 465 participants (estimated)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A | Experimental | Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses |
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B | Experimental | Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses. |
| Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ® | Active comparator | Biological: 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. |
Who may qualify
- Ages
- 6 to 11 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A0,5 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. | Biological | DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A |
| DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B0,5 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. | Biological | DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B |
| Registered 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 | Biological | Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ® |
Primary outcome
Phase I: 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
Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
Time frame: From enrollment up to 28 days after third dose
Protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
18 secondary outcomes
Phase I: Safety of the vaccine within 28 days after last dose
Time frame: From enrollment to 28 days after each dose
Phase I: Safety of the vaccine within 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
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
Time frame: From enrollment to 6 months after last dose
Phase I: Routine laboratory evaluation that probably related to the vaccination
Time frame: From enrollment to 7 days after first dose
Phase I: Serological response to diphteria toxoid and tetanus toxoid
Time frame: 28 days after the last dose immunization
Phase I: Serological response to the pertussis component (agglutinins)
Time frame: 28 days after the last dose immunization
Phase I: Geometric mean of anti-HbsAg
Time frame: 28 days after the last dose immunization
Phase I: Serological response to Hib/PRP
Time frame: 28 days after the last dose immunization
Phase I: Serological response to polio type 1, 2, and 3 (humoral immunity)
Time frame: 28 days after the last dose immunization
Phase II: Serological response to diphtheria toxoid, tetanus toxoid
Time frame: 28 days after the last dose immunization
Phase II: Serological response to the pertussis component (agglutinins)
Time frame: 28 days after the last dose immunization
Phase II: Geometric mean of anti-HbsAg
Time frame: 28 days after the last dose immunization
Phase II: Serological response to Hib/PRP
Time frame: 28 days after the last dose immunization
Phase II: Serological response to polio type 1, 2, and 3 (humoral immunity)
Time frame: 28 days after the last dose immunization
Phase II: Safety of vaccine within 30 minutes after immunization
Time frame: 30 minutes after immunization
Phase II: Safety of vaccine 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
Time frame: From 7 days to 28 days following the vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A, DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B and Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® in people with Vaccine Adverse Reaction and Vaccine Reaction, run by PT Bio Farma at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rini Mulia Sari, MD (+622033755 ext. 14102, rini.mulia@biofarma.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.