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

NCT ID: NCT01357720

Last Updated: 2013-09-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Infections

Keywords

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Vaccination Immunisation Virus Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Influenzae Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Quinvaxem

Group Type EXPERIMENTAL

Quinvaxem

Intervention Type BIOLOGICAL

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

Tritanrix Hib/HepB + Quinvaxem

Group Type ACTIVE_COMPARATOR

Quinvaxem/Tritanrix

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

42 Days

Maximum Eligible Age

64 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crucell Holland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria RZ Capeding, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute for Tropical Medicine (RITM)

Locations

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Research Institute for Tropical Medicine

City of Muntinlupa, , Philippines

Site Status

Countries

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Philippines

References

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Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29.

Reference Type DERIVED
PMID: 24176498 (View on PubMed)

Other Identifiers

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QVX-V-A001

Identifier Type: -

Identifier Source: org_study_id