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

Diphtheria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535037
• Other study ID #: 212645
• Secondary ID: 2019-002988-10
• Status: Completed
• Phase: Phase 4
• Start date: February 17, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: March 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV's DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12 weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age vaccination schedule.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• Subjects' parent(s)/Legally Acceptable Representative(s) (LAR[s]) who, in the opinion of the investigator, could and would 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.

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 have been given in accordance with local recommendations.

• Use of any investigational or non-registered 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 practice, e.g., rotavirus vaccine, that were allowed at any time during the study period. In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) would have been organized by public health authorities outside the routine immunization program, the time period described above could 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 would 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 would have been exposed to an investigational or a non-investigational vaccine/product (drug or medical device).

• Child in care.

Related Conditions & MeSH terms

• Diphtheria

Intervention

Biological:
• DTPa-HBV-IPV/Hib
3 doses (1 each at 2, 4 and 12 months of age) of DTPa-HBV-IPV/Hib vaccine administered by intramuscular injection into the right thigh
• DTaP5-HBV-IPV-Hib
3 doses (1 each at 2, 4 and 12 months of age) of DTaP5-HBV-IPV-Hib vaccine administered by intramuscular injection into the right thigh
• Pneumococcal 13-valent conjugate vaccine
3 doses (1 each at 2, 4 and 12 months of age) of pneumococcal 13-valent conjugate vaccine administered by intramuscular injection into the left thigh

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Bramsche
Germany	GSK Investigational Site	Erfurt
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Huerth	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Brandenburg
Germany	GSK Investigational Site	Moenchengladbach
Germany	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen
Germany	GSK Investigational Site	Rosenheim	Bayern
Germany	GSK Investigational Site	Schoenau Am Koenigssee	Bayern
Germany	GSK Investigational Site	Wolfsburg	Niedersachsen
Italy	GSK Investigational Site	Milano
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Boadilla Del Monte (Madrid)
Spain	GSK Investigational Site	Leganes
Spain	GSK Investigational Site	Lleida
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga	Andalucia
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations at Month 11, Based on Per Protocol Set (PPS)	Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in microgram per milliliter (µg/mL), as assessed by Enzyme-linked immunosorbent assay (ELISA).	At Month 11 (i.e., 1-month post-booster vaccination)
Primary	Percentage of Subjects With Anti-PRP Antibody Concentrations Equal to or Above (=) 5 µg/mL at Month 11, Based on PPS	The percentage of subjects with anti-PRP antibody concentrations =5 µg/mL was reported, as assessed by ELISA.	At Month 11 (i.e., 1-month post-booster vaccination)
Primary	Anti-PRP Antibody Concentrations at Month 11, Based on the Exposed Set (ES)	Anti-PRP antibody concentrations were presented as GMCs and expressed in µg/mL, as assessed by ELISA.	At Month 11 (i.e., 1-month post-booster vaccination)
Primary	Percentage of Subjects With Anti-PRP Antibody Concentrations = 5 µg/mL at Month 11, Based on ES	The percentage of subjects with anti-PRP antibody concentrations =5 µg/mL was reported, as assessed by ELISA.	At Month 11 (i.e., 1-month post-booster vaccination)
Secondary	Percentage of Subjects With Anti-PRP Antibody Concentration = 0.15 µg/mL	The percentage of subjects with anti-PRP antibody concentration equal to or above the threshold for short-term protection was reported. The threshold for short-term protection is 0.15 µg/mL.	At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
Secondary	Percentage of Subjects With Anti-PRP Antibody Concentrations = 1.0 µg/mL	The percentage of subjects with anti-PRP antibody concentration equal to or above the threshold for long-term protection was reported. The threshold for long-term protection is 1.0 µg/mL.	At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
Secondary	Anti-PRP Antibody Concentrations	Anti-PRP antibody concentrations were presented as GMCs and expressed in µg/mL, as assessed by ELISA.	At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	AEs are defined as any untoward medical occurrence in a subject or subjects, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	During the 31-day (Days 1-31) follow-up period after each vaccination (vaccines administered at 2,4 and 12 months of age)
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	A SAEs is defined as any untoward medical occurrence that, at any dose, result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect.	Throughout the entire period of the study (from Day 1 up to study end [Month 11])