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

NCT ID: NCT01986335

Last Updated: 2013-11-18

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

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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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

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Healthy

Keywords

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Combined pentavalent DTP/HB/Hib vaccine Infants Primary vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DTP/HB/Hib Vaccine (Batch: A)

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

Group Type EXPERIMENTAL

DTP/HB/Hib Vaccine

Intervention Type BIOLOGICAL

DPT/HB/Hib vaccine (Bio Farma)

DTP/HB/Hib vaccine (Batch: B)

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

Group Type EXPERIMENTAL

DTP/HB/Hib Vaccine

Intervention Type BIOLOGICAL

DPT/HB/Hib vaccine (Bio Farma)

DTP/HB/Hib vaccine (Batch: C)

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

Group Type EXPERIMENTAL

DTP/HB/Hib Vaccine

Intervention Type BIOLOGICAL

DPT/HB/Hib vaccine (Bio Farma)

Interventions

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DTP/HB/Hib Vaccine

DPT/HB/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
* 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 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
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

Hartono Gunardi, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine UI

Locations

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Jatinegara Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Mampang Prapatan Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Tebet Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Garuda Primary Health Center

Bandung, West Java, Indonesia

Site Status

Ibrahim Adji Primary Health Center

Bandung, West Java, Indonesia

Site Status

Puter Primary Health Center

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type DERIVED
PMID: 26686508 (View on PubMed)

Other Identifiers

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Penta 0312

Identifier Type: -

Identifier Source: org_study_id