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HealthyPhase 3NCT01986335

Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

A Phase 3 study testing DTP/HB/Hib Vaccine in people with Healthy, run by PT Bio Farma at 6 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine. 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
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
6 sitesIndonesia
Study dates
Aug 2012to Jan 2013
Phase
Phase 3
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
  • 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 1 month 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

6 sites in 1 country.

6 sites in 1 country

Indonesia6 sites

  • Garuda Primary Health Center

    Bandung, West Java

  • Ibrahim Adji Primary Health Center

    Bandung, West Java

  • Puter Primary Health Center

    Bandung, West Java

  • Jatinegara Primary Health Center

    Jakarta, Jakarta Special Capital Region

  • Mampang Prapatan Primary Health Center

    Jakarta, Jakarta Special Capital Region

  • Tebet Primary Health Center

    Jakarta, Jakarta Special Capital Region

Other trials in Indonesia

About this study

Official title: Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.

Read the detailed description

This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.

Conditions
Healthy
Being tested
DTP/HB/Hib Vaccine
Keywords
Combined pentavalent DTP/HB/Hib vaccine, Infants, Primary vaccination

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

    DPT/HB/Hib vaccine (Bio Farma)

Study groups in NCT01986335
Study groupRoleWhat they receive
DTP/HB/Hib Vaccine (Batch: A)ExperimentalPurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
Receives: Biological: DTP/HB/Hib Vaccine
DTP/HB/Hib vaccine (Batch: B)ExperimentalPurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
Receives: Biological: DTP/HB/Hib Vaccine
DTP/HB/Hib vaccine (Batch: C)ExperimentalPurified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
Receives: Biological: DTP/HB/Hib Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Protectivity of DTP/HB/Hib (Bio Farma) vaccine

    Number and percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHBs titer >=10mlIU/ml, and antiHib titer >= 0,15ug/ml 28 days after the last injection

    Measured: 4 months

Secondary outcomes (6)

  1. Antibody response to diphtheria between groups (three different batch numbers)

    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

  2. Antibody response to Tetanus between groups (three different batch numbers)

    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

  3. Antibody response to Pertussis component between groups (three different batch numbers)

    Serological response to 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

  4. Antibody response to Hepatitis B between groups (three different batch numbers)

    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

  5. Antibody response to Hib/PRP between groups (three different batch numbers)

    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

  6. Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups

    Number and percentage of local reaction and systemic events following vaccination.

    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.

  1. First posted18 Nov 2013 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01986335
Sponsor's protocol ID
Penta 0312
Status last verified
Oct 2013
First submitted
30 Oct 2013
Last updated
18 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Rusmil K, Gunardi H, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Satari HI, Risan NA, Prasetio D, Tarigan R, Garheni R, Milanti M, Hadinegoro SR, Tanuwidjaja S, Bachtiar NS, Sari RM. The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule. BMC Pediatr. 2015 Dec 19;15:219. doi: 10.1186/s12887-015-0525-2.

    PubMed 26686508

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTP/HB/Hib Vaccine in people with Healthy, run by PT Bio Farma at 6 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 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

On the ClinicalTrials.gov record for NCT01986335, which also lists 1 linked publication.

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.

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