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

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

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

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Haemophilus Influenzae Infections
• Intervention / Treatment: Biological: Quinvaxem

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Pasteur Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at 5 months (equivalent to 1 month after the third vaccination)
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)	at 14 months (equivalent to 12 months after the first vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From Day 1 up to 30 days after the third vaccination

Collaborators and Investigators

• Sponsor: Crucell Holland BV
• Investigators: Principal Investigator: Tran Ngoc Huu, PhD, MD, Pasteur Institute of Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: May 27, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Estimate): September 9, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Immunity; Vaccination; Hepatitis B; Pertussis; Immunisation; Virus; Diphtheria; Tetanus; Haemophilus Influenzae
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Neurologic Manifestations; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Orthomyxoviridae Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Pasteurellaceae Infections; Hepatitis B; Whooping Cough; Hepatitis; Hepatitis A; Influenza, Human; Tetanus; Diphtheria; Tetany; Haemophilus Infections
• Other Study ID Numbers: QVX-V-C001