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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01362517
First received: May 26, 2011
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Influenzae Infections
Biological: Quinvaxem
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component [ Time Frame: at 5 months (equivalent to 1 month after the third vaccination) ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 14 months (equivalent to 12 months after the first vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Day 1 up to 30 days after the third vaccination ] [ Designated as safety issue: Yes ]
    Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection


Enrollment: 131
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quinvaxem Biological: Quinvaxem

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


  Eligibility

Ages Eligible for Study:   60 Days to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362517

Locations
Vietnam
Pasteur Institute
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Tran Ngoc Huu, PhD, MD Pasteur Institute of Ho Chi Minh City
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01362517     History of Changes
Other Study ID Numbers: QVX-V-C001
Study First Received: May 26, 2011
Results First Received: March 27, 2013
Last Updated: August 29, 2013
Health Authority: Vietnam: Ministry of Health

Keywords provided by Crucell Holland BV:
Vaccination
Immunisation
Virus
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Influenzae
Immunity

Additional relevant MeSH terms:
Tetanus
Tetany
Hepatitis
Hepatitis A
Influenza, Human
Hepatitis B
Whooping Cough
Diphtheria
Haemophilus Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on September 29, 2014