A phase IV, single-blind, randomised, controlled, multi-country study to evaluate the immunogenicity and safety of GSK’s Infanrix hexa (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV’s Vaxelis (DTaP5-HBV-IPV-Hib), when administered intramuscularly according to a 2-, 4- and 12-month schedule in healthy infants and toddlers

GlaxoSmithKline Biologicals SA0 sites500 target enrollmentAugust 20, 2020

ConditionsHealthy volunteers [Primary and booster immunization of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)]MedDRA version: 21.1Level: LLTClassification code 10054187Term: Polio immunizationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1Level: LLTClassification code 10069593Term: Pertussis immunizationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1Level: LLTClassification code 10054180Term: Diphtheria immunizationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1Level: LLTClassification code 10054183Term: Tetanus immunizationSystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsInfanrix hexa

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers [Primary and booster immunization of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)]
Sponsor: GlaxoSmithKline Biologicals SA
Enrollment: 500
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 20, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals SA

Eligibility Criteria

Inclusion Criteria

•\-Subjects' parent(s)/Legally Acceptable Representative(s) (LAR\[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow\-up visits).
•\-Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
•\-A male or female child between and including 6 and 12 weeks of age (42 to 84 days) at the time of the first vaccination.
•\-Subject born after at least 37 weeks of gestation.
•\-Healthy subjects as established by the investigator based on medical history and the clinical examination before entering into the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 500
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range 0
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•\-Any clinical condition that, in the opinion of the investigator, might pose any risk to the subject due to participation in the study. As with other vaccines, administration of DTPa\-HBV\-IPV/Hib should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is not a contraindication.
•\-Known history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib diseases since birth.
•\-History of any reaction or hypersensitivity likely to be caused or exacerbated by any excipient or active component of the vaccine(s).
•\-Any confirmed or suspected immunosuppressive or immunodeficient condition, including malignancies, based on medical history and physical examination (no laboratory testing required).
•\-Family history of congenital or hereditary immunodeficiency.
•\-Major congenital defects, as assessed by the investigator.
•\-Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined via medical history including physical examination.
•\-Medical history of neurological disorder, including seizures.
•\-Previous vaccination for diphtheria, tetanus, pertussis, HBV, poliomyelitis, Hib diseases and previous vaccination against pneumococcal infection with pneumococcal conjugate vaccine, with the exception of a birth dose of HBV vaccine, which may be given in accordance with local recommendations.
•\-Use of any investigational or nonregistered product (drug, vaccine, or medical device) other than the study vaccine(s) during the period starting 30 days before the first dose of study vaccine(s) (Day \-29 to Day 1\), or planned use during the study period.