A study to evaluate immunogenicity and safety of GlaxoSmithKline (GSK)'s Infanrix hexa vaccine (DTPa HBV IPV/Hib) versus MCM Vaccine BV's Vaxelis vaccine (DTaP5 HBV IPV Hib) in healthy infants and toddlers

Phase 1

• Conditions: DiphtheriaTetanusWhooping coughInfection of the liverInvasive bacterial disease such as Meningitis or PneumoniaPolio; 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]

• Registration Number: EUCTR2019-002988-10-IT
• Lead Sponsor: GLAXOSMITHKLINE BIOLOGICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-31
• Study Completion: 2022-11-10
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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:
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

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.
-Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine(s) with the exception of administration of vaccines given as part of the national immunization schedule and as part of routine vaccination pr actice, e.g., rotavirus vaccine, that are allowed at any time during the study period. In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine
immunization programme, the time period described above can be reduced if necessary for that mass vaccination vaccine, provided this vaccine/product(s) is licensed and used according to its Product Information.
-Administration of long-acting immune-modifying drugs in the period starting 30 days before the first dose and at any time during the study period.
-Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.
-Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone =0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.
-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a noninvestigational vaccine/product (drug or medical
device).
-Child in care.

Study & Design

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