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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Philippines

Study Type

Interventional

Intervention

Quinvaxem in Uniject

Quinvaxem in single dose vials

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity

Eligibility Criteria

42 Days - 64 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Institute for Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quinvaxem in Uniject

Quinvaxem in single dose vials

Arm Description

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

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

Outcomes

Primary Outcome Measures

Seroprotection Rate: Anti-PRP Antibodies

Seroprotection Rate: Anti-hepatitis B Surface Antibodies

Anti-diphtheria Toxoid Antibodies

Seroprotection Rate: Anti-tetanus Toxoid Antibodies

Seroprotection Rate: Anti-B. Pertussis Antibodies

Secondary Outcome Measures

Full Information

NCT ID

NCT01917357

First Posted

August 5, 2013

Last Updated

July 12, 2014

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01917357

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quinvaxem in Uniject

Arm Type

Experimental

Arm Description

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

Arm Title

Quinvaxem in single dose vials

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Quinvaxem in Uniject

Intervention Type

Biological

Intervention Name(s)

Quinvaxem in single dose vials

Primary Outcome Measure Information:

Title

Seroprotection Rate: Anti-PRP Antibodies

Time Frame