Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

Hepatitis B Clinical Trial

Official title:

A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357720
• Other study ID #: QVX-V-A001
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2011
• Last updated: August 29, 2013
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: August 2013
• 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 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, 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) 1 month after completion of the 6-10-14 week vaccination course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• 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 guardian of the subject

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

• Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits

Exclusion Criteria:

• Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or 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 Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 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 Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP)

• History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate

• Significant acute infection

• Any condition which, 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: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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 Weeks 6, 10 and 14
• Quinvaxem/Tritanrix
A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14

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	Percentage of subjects with an anti-PRP titer =0.15 µg/mL (i.e. seroprotection rate)	1 month after the third vaccination	No
Primary	Seroprotection Rate: Anti-hepatitis B Surface Antibodies	Percentage of subjects with an anti-hepatitis B surface antibody titer =10 IU/L (i.e. seroprotection rate)	1 month after the third vaccination	No
Primary	Seroprotection Rate: Anti-diphtheria Toxoid Antibodies	Percentage of subjects with antibody levels against diphtheria toxoid =0.1 IU/mL (i.e. seroprotection rate)	1 month after the third vaccination	No
Primary	Seroprotection Rate: Anti-tetanus Toxoid Antibodies	Percentage of subjects with antibody levels against tetanus toxoid =0.1 IU/mL (i.e. seroprotection rate)	1 month after the third vaccination	No
Primary	Seroprotection Rate: Anti-B. Pertussis Antibodies	Percentage of subjects with an anti-B. pertussis antibody titer =20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)	1 month after the third vaccination	No