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

Brief Title

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

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

Brief 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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Seroprotection Rate: Anti-PRP Antibodies

Condition

Diphtheria

Intervention

Quinvaxem

Study Arms / Comparison Groups

 Quinvaxem

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

400

Start Date

May 2011

Completion Date

September 2011

Primary Completion Date

September 2011

Eligibility Criteria

        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
      

Gender

All

Ages

42 Days - 64 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Maria RZ Capeding, MD, , 

Location Countries

Philippines

Location Countries

Philippines

NCT ID

NCT01357720

Organization ID

QVX-V-A001

Responsible Party

Sponsor

Study Sponsor

Crucell Holland BV

Study Sponsor

Maria RZ Capeding, MD, Principal Investigator, Research Institute for Tropical Medicine (RITM)

Verification Date

August 2013