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Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

Primary Purpose

Diphtheria, Pertussis, Tetanus

Status
Completed
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
Quinvaxem
Sponsored by
Crucell Holland BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diphtheria focused on measuring Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity

Eligibility Criteria

60 Days - 120 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems
  • Have a normal gestational age (≥ 37 weeks); birth weight > 2.5 kg
  • There is no congenital disease detected through interview and clinical examination
  • Already had or not yet received Hepatitis B vaccination at birth
  • Do not have dermatological diseases such as eczema, allergies
  • Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures

Exclusion Criteria:

  • Already vaccinated with DTP vaccine
  • Have an acute infection at the time of study vaccination
  • Contraindications to Quinvaxem
  • Receiving treatment with systemic corticosteroids
  • Currently participating in another clinical trial
  • In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth
  • Parents intend to move to another location during the study (the next 12 months)

Sites / Locations

  • Pasteur Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quinvaxem

Arm Description

Outcomes

Primary Outcome Measures

Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)

Secondary Outcome Measures

Safety: Adverse and Serious Adverse Events
Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection

Full Information

First Posted
May 26, 2011
Last Updated
August 29, 2013
Sponsor
Crucell Holland BV
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1. Study Identification

Unique Protocol Identification Number
NCT01362517
Brief Title
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
Official Title
Assessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae Among Healthy Vietnamese Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae Infections
Keywords
Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quinvaxem
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Quinvaxem
Intervention Description
A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at 2, 3 and 4 months of age
Primary Outcome Measure Information:
Title
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Description
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
Time Frame
at 5 months (equivalent to 1 month after the third vaccination)
Title
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Description
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
Time Frame
at 14 months (equivalent to 12 months after the first vaccination
Secondary Outcome Measure Information:
Title
Safety: Adverse and Serious Adverse Events
Description
Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection
Time Frame
From Day 1 up to 30 days after the third vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems Have a normal gestational age (≥ 37 weeks); birth weight > 2.5 kg There is no congenital disease detected through interview and clinical examination Already had or not yet received Hepatitis B vaccination at birth Do not have dermatological diseases such as eczema, allergies Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures Exclusion Criteria: Already vaccinated with DTP vaccine Have an acute infection at the time of study vaccination Contraindications to Quinvaxem Receiving treatment with systemic corticosteroids Currently participating in another clinical trial In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth Parents intend to move to another location during the study (the next 12 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tran Ngoc Huu, PhD, MD
Organizational Affiliation
Pasteur Institute of Ho Chi Minh City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pasteur Institute
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

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