HealthyPhase 1NCT01977196
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
A Phase 1 study testing DPT/HepatitisB/Hib vaccine in people with Healthy, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection. Read more about this study
- Who is it for?
- Ages 6 to 11 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DPT/HepatitisB/Hib vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2011to Jul 2011
- Phase
- Phase 1
- 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 week of age
- Infant born after 37-42 week of pregnancy
- Infant weighting more than 2.5 kg at birth
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
- Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
Who cannot join
- Child concomitantly enroll or schedule to be enroll in another trial
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
- Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
- History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
- Known history of congenital or acquired immunodeficiency (including HIV infection)
- Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 minggu)
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 objective
- Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.
Read the detailed description
This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.
- Conditions
- Healthy
- Being tested
- DPT/HepatitisB/Hib vaccine
- Keywords
- DTB/HB/Hib vaccine, Infants, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPT/HepatitisB/Hib vaccineBiological
Also called Pentavalent
DPT/HepatitisB/Hib vaccine (Bio Farma)
| Study group | Role | What they receive |
|---|---|---|
| DTP/HepatitisB/Hib vaccine | Experimental | Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal Receives: Biological: DPT/HepatitisB/Hib vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reactions
Measured: 30 minutes
Secondary outcomes (2)
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reaction
Measured: 28 hours, 48 hours, 72 hours, 28 days
To asses the immunogenicity
Percentage of infants with increasing antibody
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kusnandi Rusmil, PhD, Principal investigator, Faculty of Medicine UNPAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977196
- Sponsor's protocol ID
- Penta 0111
- Status last verified
- Oct 2013
- First submitted
- 30 Oct 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
- ClinicalTrials.gov ID
- NCT01977196
- Acronym / sponsor ID
- Penta 0111
- Conditions
- Healthy
- Keywords
- DTB/HB/Hib vaccine, Infants, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Nov 2013 (estimated)
- 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.
The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.
Detailed description
This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTP/HepatitisB/Hib vaccine | Experimental | Biological: DPT/HepatitisB/Hib vaccinePurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal |
Who may qualify
- Ages
- 6 to 11 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infant 6-11 week of age
- Infant born after 37-42 week of pregnancy
- Infant weighting more than 2.5 kg at birth
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
- Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
Key exclusion criteria (9 listed)
- Child concomitantly enroll or schedule to be enroll in another trial
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
- Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
- History of uncontrolled coagulopathy or blood disorder 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 |
|---|---|---|
| DPT/HepatitisB/Hib vaccineAlso: PentavalentDPT/HepatitisB/Hib vaccine (Bio Farma) | Biological | DTP/HepatitisB/Hib vaccine |
Primary outcome
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Time frame: 30 minutes
Local and systemic reactions
2 secondary outcomes
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Time frame: 28 hours, 48 hours, 72 hours, 28 days
To asses the immunogenicity
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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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.
Kusnandi Rusmil, PhD principal investigator
Faculty of Medicine UNPAD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DPT/HepatitisB/Hib vaccine in people with Healthy, run by PT Bio Farma at 1 site 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: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma) (time frame: 30 minutes). 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 6 Nov 2013.