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

NCT01917357 | Completed Phase 3

• 1 other identifier: QVX-V-D001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Infections

Keywords

Vaccination; Immunisation; Virus; Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae; Immunity

Outcome Measures

Primary Outcomes (5)

• Seroprotection Rate: Anti-PRP Antibodies

  1 month after the third vaccination

• Seroprotection Rate: Anti-hepatitis B Surface Antibodies

  1 month after the third vaccination

• Anti-diphtheria Toxoid Antibodies

  1 month after the third vaccination

• Seroprotection Rate: Anti-tetanus Toxoid Antibodies

  1 month after the third vaccination

• Seroprotection Rate: Anti-B. Pertussis Antibodies

  1 month after the third vaccination

Study Arms (2)

Quinvaxem in Uniject

EXPERIMENTAL

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 intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using the Uniject pre-filled injection device

Biological: Quinvaxem in Uniject

Quinvaxem in single dose vials

ACTIVE COMPARATOR

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 intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using a needle and syringe from single dose vials

Biological: Quinvaxem in single dose vials

Interventions

Quinvaxem in Uniject BIOLOGICAL

Quinvaxem in Uniject

Quinvaxem in single dose vials BIOLOGICAL

Quinvaxem in single dose vials

Eligibility Criteria

• Age: 42 Days - 64 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (1)

Research Institute for Tropical Medicine

City of Muntinlupa, Philippines

Location

MeSH Terms

Conditions

Diphtheria; Whooping Cough; Tetanus; Hepatitis B; Haemophilus Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Study Officials

• Maria RZ Capeding, MD

  Research Institute for Tropical Medicine (RITM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 6, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-02

Locations

PH (1)