Safety of Hib Vaccine (Bio Farma) | NCT01977170

Studies
Safety of Hib Vaccine (Bio Farma)

NCT01977170

Sponsor

PT Bio Farma

Status

Completed

Last Update Posted

Nov 6, 2013Estimated

Enrollment

25Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Hib/PRP-T vaccine

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 29, 2013

First Submission Date that Met QC Criteria

Nov 5, 2013

First Posted Date

Nov 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2013

Last Update Posted Date

Nov 6, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Detailed Description

This trial was an open-label study, no randomization, and no placebo or control group. Total 25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hib/PRP-T vaccine	Experimental	One dose, correspond to 0.5 ml, composed of: PRP-T 10ug NaCl 0.85% Frequency: 1 injection	Biological: Hib/PRP-T vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hib/PRP-T vaccine	Biological	Hib liquid vaccine	Hib/PRP-T vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence rate of adverse event of Hib vaccine (Bio Farma)	Local and systemic reactions	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the antibody function serum using serum bactericidal activities test	Presence of serum of bactericidal activities after immunization.	28 days
Incidence rate of adverse event of Hib vaccine (Bio Farma)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (age 18 - 40 years old)
Provision of written informed consent
Good health according to the clinical investigator
Willingness and ability to adhere to the regimen of the study

Exclusion Criteria:

Known not enrolled in other study
Pregnancy or lactation
Known or suspected allergy to any of the vaccine component (by medical history)
History of unusual reaction to any previous vaccination
Known or suspected immune deficiency, or use of medication that may influence the immune system
Prior respiratory infection
Other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study
Acute febrile illness (temperature > 37.5 Celsius)
Present evidence of serious diseases demanding medical treatment
Any significant congenital or chronic disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kusnandi Rusmil, PhD	Faculty of Medicine UNPAD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hasan Sadikin Hospital		Bandung	West Java	40161	Indonesia

Intervention Browse Module

MeSH Terms

ID	Term
C055753	Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided