Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine

November 11, 2013 updated by: PT Bio Farma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia
        • Garuda Primary Health Center
      • Bandung, West Java, Indonesia
        • Puter Primary Health Center
      • Bandung, West Java, Indonesia
        • Ibrahim Adji Primary Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DTP/HB/Hib vaccine

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
Biological: DTP/HB/Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly
Other Names:
  • Pentavalent
Active Comparator: DTP/HB and Hib vaccine

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
Biological: DTP/HB and Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody response to diphteria toxoid in both group
Time Frame: 4 months
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.
4 months
Antibody response to Tetanus Toxoid in both group
Time Frame: 4 months
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
4 months
Antibody response to Pertussis component in both group
Time Frame: 4 months
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.
4 months
Antibody response to Hepatitis B in both group
Time Frame: 4 months
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.
4 months
Antibody response to PRP-T in both group
Time Frame: 4 months
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
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
Local and systemic reaction
30 minutes, 72 hours, 28 days after immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Bio Farma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Penta 0211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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