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

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:

MedlinePlus related topics: Diphtheria Flu Flu Shot Hepatitis Hepatitis A Hepatitis B Tetanus Whooping Cough

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Diphtheria Haemophilus Influenzae

U.S. FDA Resources

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 (Child)
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


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, 2016