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

NCT04535037 | Completed Phase 4 Results

• 2 other identifiers: 2126452019-002988-10
• Study Type: interventional
• Target: 500
• Locations: 3 countries
• Sites: 20

Brief 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.

Conditions

Diphtheria

Keywords

Primary immunization; Immunogenicity; Safety; Diphtheria; Tetanus; Acellular pertussis; Hepatitis B; Inactivated poliovirus; Haemophilus influenzae type b

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• Percentage of Subjects With Anti-PRP Antibody Concentration ≥ 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)

• Percentage of Subjects With Anti-PRP Antibody Concentrations ≥ 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)

• Anti-PRP Antibody Concentrations

  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)

• Number of Subjects With Unsolicited Adverse Events (AEs)

  During the 31-day (Days 1-31) follow-up period after each vaccination (vaccines administered at 2,4 and 12 months of age)

• Number of Subjects With Serious Adverse Events (SAEs)

  Throughout the entire period of the study (from Day 1 up to study end [Month 11])

Study Arms (2)

Infanrix Hexa

EXPERIMENTAL

All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTPa-HBV-IPV/Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

Biological: DTPa-HBV-IPV/Hib; Biological: Pneumococcal 13-valent conjugate vaccine

Vaxelis

ACTIVE COMPARATOR

All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTaP5 HBV IPV Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

Biological: DTaP5-HBV-IPV-Hib; Biological: Pneumococcal 13-valent conjugate vaccine

Interventions

DTPa-HBV-IPV/Hib BIOLOGICAL

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

Also known as: Infanrix hexa

Infanrix Hexa

DTaP5-HBV-IPV-Hib BIOLOGICAL

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

Also known as: Vaxelis

Vaxelis

Pneumococcal 13-valent conjugate vaccine BIOLOGICAL

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

Also known as: Prevenar 13

Infanrix Hexa; Vaxelis

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Rosenheim, Bavaria, 83026, Germany

Location

GSK Investigational Site

Schönau am Königssee, Bavaria, 83471, Germany

Location

GSK Investigational Site

Leipzig, Brandenburg, 16269, Germany

Location

GSK Investigational Site

Wolfsburg, Lower Saxony, 38448, Germany

Location

GSK Investigational Site

Hürth, North Rhine-Westphalia, 50354, Germany

Location

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, 41236, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Bramsche, 49565, Germany

Location

GSK Investigational Site

Erfurt, 99086, Germany

Location

GSK Investigational Site

Mönchengladbach, 41236, Germany

Location

GSK Investigational Site

Milan, 20122, Italy

Location

GSK Investigational Site

Málaga, Andalusia, 29004, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Boadilla Del Monte (Madrid), 28660, Spain

Location

GSK Investigational Site

Leganés, 28911, Spain

Location

GSK Investigational Site

Lleida, 25198, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

Related Publications (1)

• Martinon-Torres F, Salamanca de la Cueva I, Horn M, Westerholt S, Bosis S, Meyer N, Cheuvart B, Virk N, Jakes RW, Duchenne M, Van den Steen P. Disparate kinetics in immune response of two different Haemophilus influenzae type b conjugate vaccines: Immunogenicity and safety observations from a randomized controlled phase IV study in healthy infants and toddlers using a 2+1 schedule. Hum Vaccin Immunother. 2024 Dec 31;20(1):2342630. doi: 10.1080/21645515.2024.2342630. Epub 2024 Apr 30.

  PMID: 38687024 BACKGROUND

MeSH Terms

Conditions

Diphtheria; Tetanus; Hepatitis B; Haemophilus Infections

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; Vaxelis; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: May 26, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: August 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

IT (1); ES (9); DE (10)