NCT01986322

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2 healthy

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
Last Updated

November 18, 2013

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

October 30, 2013

Last Update Submit

November 11, 2013

Conditions

Healthy

Keywords

DTP/HB/Hib vaccineImmunogenicityInfantsSafety

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months

Secondary Outcomes (6)

  • Antibody response to diphteria toxoid in both group

    4 months

  • Antibody response to Tetanus Toxoid in both group

    4 months

  • Antibody response to Pertussis component in both group

    4 months

  • Antibody response to Hepatitis B in both group

    4 months

  • Antibody response to PRP-T in both group

    4 months

  • +1 more secondary outcomes

Study Arms (2)

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

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

Biological: DTP/HB and Hib vaccine

Interventions

DTP/HB/Hib vaccineBIOLOGICAL

Dosage equal to 0.5 mL administered intramuscularly

Also known as: Pentavalent
DTP/HB/Hib vaccine
DTP/HB and Hib vaccineBIOLOGICAL

Dosage equal to 0.5 mL administered intramuscularly

DTP/HB and Hib vaccine

Eligibility Criteria

Age6 Weeks - 11 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Garuda Primary Health Center

Bandung, West Java, Indonesia

Location

Ibrahim Adji Primary Health Care Center

Bandung, West Java, Indonesia

Location

Puter Primary Health Center

Bandung, West Java, Indonesia

Location

MeSH Terms

Interventions

HibTITER protein, Haemophilus influenzae

Study Officials

  • Kusnandi Rusmil, PhD

    Faculty of Medicine UNPAD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 18, 2013

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 18, 2013

Record last verified: 2013-11

Locations

ID(3)