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

Crucell

Status and phase

Completed

Phase 4

Conditions

Diphtheria

Haemophilus Infections

Hepatitis B

Tetanus

Pertussis

Treatments

Biological: Quinvaxem

Biological: Quinvaxem/Tritanrix

Study type

Interventional

Funder types

Industry

Identifiers

NCT01357720

QVX-V-A001

Details and patient eligibility

About

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.

Enrollment

400 patients

Sex

All

Ages

42 to 64 days old

Volunteers

Accepts 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 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