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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae Infections	Biological: Quinvaxem	Phase 3

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	131 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	April 2010
Actual Primary Completion Date :	July 2010
Actual Study Completion Date :	April 2011

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component [ Time Frame: at 5 months (equivalent to 1 month after the third vaccination) ]
   Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
2. Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component [ Time Frame: at 14 months (equivalent to 12 months after the first vaccination ]
   Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)

Secondary Outcome Measures :

1. Safety: Adverse and Serious Adverse Events [ Time Frame: From Day 1 up to 30 days after the third vaccination ]
   Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	60 Days to 120 Days (Child)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Crucell Holland BV
ClinicalTrials.gov Identifier:	NCT01362517 History of Changes
Other Study ID Numbers:	QVX-V-C001
First Posted:	May 30, 2011
Results First Posted:	June 24, 2013
Last Update Posted:	September 9, 2013
Last Verified:	August 2013

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