NCT01977170

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
Last Updated

November 6, 2013

Status Verified

October 1, 2013

Enrollment Period

1 month

First QC Date

October 29, 2013

Last Update Submit

November 5, 2013

Conditions

Healthy

Keywords

AdultsHib vaccinesImmunogenicitySafety

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of adverse event of Hib vaccine (Bio Farma)

    Local and systemic reactions

    30 minutes

Secondary Outcomes (2)

  • To evaluate the antibody function serum using serum bactericidal activities test

    28 days

  • Incidence rate of adverse event of Hib vaccine (Bio Farma)

    28 hours, 48 hours, 72 hours, 28 days

Study Arms (1)

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

Hib/PRP-T vaccineBIOLOGICAL

Hib liquid vaccine

Hib/PRP-T vaccine

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Interventions

Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

Study Officials

  • Kusnandi Rusmil, PhD

    Faculty of Medicine UNPAD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 6, 2013

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 6, 2013

Record last verified: 2013-10

Locations

ID(1)