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The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)

NCT ID: NCT01977196

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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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

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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

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Healthy

Keywords

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DTB/HB/Hib vaccine Infants Phase I

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DTP/HepatitisB/Hib vaccine

Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal

Group Type EXPERIMENTAL

DPT/HepatitisB/Hib vaccine

Intervention Type BIOLOGICAL

DPT/HepatitisB/Hib vaccine (Bio Farma)

Interventions

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DPT/HepatitisB/Hib vaccine

DPT/HepatitisB/Hib vaccine (Bio Farma)

Intervention Type BIOLOGICAL

Other Intervention Names

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Pentavalent

Eligibility Criteria

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Inclusion Criteria

* 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

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 minggu)
* 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
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

11 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PT Bio Farma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kusnandi Rusmil, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine UNPAD

Locations

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Hasan Sadikin Hospital

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Penta 0111

Identifier Type: -

Identifier Source: org_study_id