HealthyPhase 2NCT01986322
Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine
A Phase 2 study testing DTP/HB/Hib vaccine and DTP/HB and Hib vaccine in people with Healthy, run by PT Bio Farma at 3 sites in Indonesia.
Trial summary
The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously. 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?
- DTP/HB/Hib vaccine and DTP/HB and Hib vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesIndonesia
- Study dates
- Jul 2011to Jan 2012
- Phase
- Phase 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 week of age
- Infant born after 37-42 week of pregnancy
- Infant weighing 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
- Mother at least graduate from elementary school
- Received Hepatitis B vaccine (Bio Farma) at birth
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 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 objective
- Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Garuda Primary Health Center
Bandung, West Java
Ibrahim Adji Primary Health Care Center
Bandung, West Java
Puter Primary Health Center
Bandung, West Java
About this study
Official title: Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants
The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.
Read the detailed description
This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.
- Conditions
- Healthy
- Being tested
- DTP/HB/Hib vaccine, DTP/HB and Hib vaccine
- Keywords
- DTP/HB/Hib vaccine, Immunogenicity, Infants, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTP/HB/Hib vaccineBiological
Also called Pentavalent
Dosage equal to 0.5 mL administered intramuscularly
DTP/HB and Hib vaccineBiological
Dosage equal to 0.5 mL administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| DTP/HB/Hib vaccine | Experimental | Group A will receive DTP/HB/Hib combination vaccine at 6-11, 10-15 and 14-19 weeks of age.
DTP/HB/Hib component:
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal Receives: Biological: DTP/HB/Hib vaccine |
| DTP/HB and Hib vaccine | Active comparator | Group B will receive DTP/HB and Hib Vaccines separately at 6-11,10-15, 14-19 weeks of age
DTP/HB component:
Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis rHbsAg Aluminum phosphate Natrium Chloride Thimerosal
Hib component:
Purified Haemophilus influenzae type b polysaccharide 10 mcg Receives: Biological: DTP/HB and Hib vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protectivity of DTP/HB/Hib (Bio Farma) vaccine
Percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHbs titer >=10mlIU/ml, and antiPRP-TT titer >= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group
Measured: 4 months
Secondary outcomes (6)
Antibody response to diphteria toxoid in both group
Serological response to diphteria toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=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: 4 months
Antibody response to Tetanus Toxoid in both group
Serological response to tetanus toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=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: 4 months
Antibody response to Pertussis component in both group
Serological response to the pertussis component (agglutinins): GMT,percentage of infants with titre >=40, >=80,>=160 and >=320 (1/dil.), percentage of infants with increasing antibody titer >=4 times.
Measured: 4 months
Antibody response to Hepatitis B in both group
Serological response to Hepatitis B: Geometric mean of anti-HBs, percentage of infants with titer >=10mlIU/ml, percentage of infants with increasing antibody titer >=4 times and/ or percentage of infants with transition of seronegative to seropositive.
Measured: 4 months
Antibody response to PRP-T in both group
Serological response to Hib/PRP: GMT, percentage of infants with titre >=1ug/ml and >=0.15ug/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive
Measured: 4 months
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Local and systemic reaction
Measured: 30 minutes, 72 hours, 28 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 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
- NCT01986322
- Sponsor's protocol ID
- Penta 0211
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2013
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants
- ClinicalTrials.gov ID
- NCT01986322
- Acronym / sponsor ID
- Penta 0211
- Conditions
- Healthy
- Keywords
- DTP/HB/Hib vaccine, Immunogenicity, Infants, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 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 main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.
Detailed description
This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTP/HB/Hib vaccine | Experimental | Biological: DTP/HB/Hib vaccineGroup A will receive DTP/HB/Hib combination vaccine at 6-11, 10-15 and 14-19 weeks of age. DTP/HB/Hib component: Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal |
| DTP/HB and Hib vaccine | Active comparator | Biological: DTP/HB and Hib vaccineGroup B will receive DTP/HB and Hib Vaccines separately at 6-11,10-15, 14-19 weeks of age DTP/HB component: Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis rHbsAg Aluminum phosphate Natrium Chloride Thimerosal Hib component: Purified Haemophilus influenzae type b polysaccharide 10 mcg |
Who may qualify
- Ages
- 6 to 11 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infant 6-11 week of age
- Infant born after 37-42 week of pregnancy
- Infant weighing 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 |
|---|---|---|
| DTP/HB/Hib vaccineAlso: PentavalentDosage equal to 0.5 mL administered intramuscularly | Biological | DTP/HB/Hib vaccine |
| DTP/HB and Hib vaccineDosage equal to 0.5 mL administered intramuscularly | Biological | DTP/HB and Hib vaccine |
Primary outcome
Protectivity of DTP/HB/Hib (Bio Farma) vaccine
Time frame: 4 months
Percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHbs titer >=10mlIU/ml, and antiPRP-TT titer >= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group
6 secondary outcomes
Antibody response to diphteria toxoid in both group
Time frame: 4 months
Antibody response to Tetanus Toxoid in both group
Time frame: 4 months
Antibody response to Pertussis component in both group
Time frame: 4 months
Antibody response to Hepatitis B in both group
Time frame: 4 months
Antibody response to PRP-T in both group
Time frame: 4 months
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
Time frame: 30 minutes, 72 hours, 28 days after immunization
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 18 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DTP/HB/Hib vaccine and DTP/HB and Hib vaccine in people with Healthy, 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 7 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 18 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 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 phase mean?
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?
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?
Protectivity of DTP/HB/Hib (Bio Farma) vaccine (time frame: 4 months). 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 18 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.