Evaluate the efficacy and safety la vacuna hexavalente (Hexyon) in preterm infants

Phase 1

• Conditions: Vaccines, Bacterial and viral vaccines combined; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-004581-34-ES
• Lead Sponsor: Fundación Instituto Hispalense de Pediatría

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

•Preterm infants born between 24 (+0 days) – 36 (+6 days) weeks (42-90 days) (mean gestational age ± standard deviation, 31.05 ± 3.45 weeks) of gestation.
•Subjects whose parents or legal guardians be able and wish to comply with all protocol requirements.
-Male or female children 6 to 12 (42-90 days) weeks of age at first vaccine.
-Written informed consent provided by the patient’s parents or legal guardians.
-Healthy subjects according the investigator criteria prior to the enrolling in the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Foster children (male or female)
•Receipt of any investigational product (drug or vaccine) within 30 days before the first dose of study vaccine or planned during the trial period.
•Prolonged administration (defined as a total period of over 14 days) of immunosuppressive or other immunomodulatory drugs since the birth. In case of corticoids, this implies = 0.5 mg/kg/day prednisone dose or equivalent. Inhaled or topic steroids will be allowed.

•During the study period, simultaneous participation in another trial in which the subject have received or will be expected to receive investigational or non experimental product (pharmaceutical product or medical device).
•Taking in account the clinical history and physical exam, any known or suspected status of immunosuppression or immunodeficiency.
•Family history of congenital or inherited immunodeficiency.
•History of reaction or hypersensibility probably exacerbated by any of the vaccine components.
•Major congenital defects or serious chronic diseases, including Kawasaki syndrome.
•History of severe neurologic damage or seizures, including both disorders and episodes of hypotension or hypo-responsiveness, encephalopathies or any type of convulsions (febrile and afebrile).
•Episode of apnea (cessation of respiration > 20s) within 7 days before vaccination.
•Acute disease and/or fever at recruitment in the study.
?Fever is defined as a temperature = 37.5ºC (oral or axial temperature) or = 38.0º C (rectal temperature).
?Subjects with mild diseases (such us mild diarrhea or mild upper respiratory tract infection) without fever could be recruited at physician discretion.
•History of any immunoglobulin therapy and/or blood product since the birth or scheduled administration during the trial.
•History of diphtheria, tetanus, pertussis, hepatitis B, polio and Hib vaccination or disease.
•Any disease which in the opinion of the investigator would interfere with the evaluation of the objectives of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified