A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject

Hepatitis B Clinical Trial

Official title:

A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917357
• Other study ID #: QVX-V-D001
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2013
• Last updated: July 12, 2014
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2014
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 64 Days

Eligibility

Inclusion Criteria:

• A male or female between, and including, 42 and 64 days of age at the time of the first vaccination

• Written informed consent obtained from parents/legal guardians of the subject

• Free of obvious health problems as established by medical history and/or clinical examination before entering the study

• HepB vaccination at birth (within 48 hours)

• Available for all scheduled study visits

Exclusion Criteria:

• Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up

• Planned administration of a vaccine not foreseen by the Study Protocol

• Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)

• Administration of parenteral immunoglobulin preparation and/or blood products since birth

• Previous vaccination against Hib and/or DTP

• History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal

• Clinically significant acute infection

• Clinically significant acute illness

• Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

• Participation in another clinical study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Hepatitis B
• Pertussis
• Tetanus

Intervention

Biological:
• Quinvaxem in Uniject

• Quinvaxem in single dose vials

Locations

Country	Name	City	State
Philippines	Research Institute for Tropical Medicine	Muntinlupa City

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection Rate: Anti-PRP Antibodies		1 month after the third vaccination	No
Primary	Seroprotection Rate: Anti-hepatitis B Surface Antibodies		1 month after the third vaccination	No
Primary	Anti-diphtheria Toxoid Antibodies		1 month after the third vaccination	No
Primary	Seroprotection Rate: Anti-tetanus Toxoid Antibodies		1 month after the third vaccination	No
Primary	Seroprotection Rate: Anti-B. Pertussis Antibodies		1 month after the third vaccination	No