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Diphtheria
+4

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

Sponsored by Crucell Holland BV

About this trial

Last updated 12 years ago

Study ID

QVX-V-A001

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
42 to 64 Years
All
All

Trial Timing

Ended 14 years ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status