DiphtheriaPhase 4NCT04535037

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

A Phase 4 study testing DTPa-HBV-IPV/Hib, DTaP5-HBV-IPV-Hib and Pneumococcal 13-valent conjugate vaccine in people with Diphtheria, run by GlaxoSmithKline at 20 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Diphtheria
What is being tested?: DTPa-HBV-IPV/Hib, DTaP5-HBV-IPV-Hib and Pneumococcal 13-valent conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 20 sitesin 3 countries
Study dates: 26 May 2021to 25 Jul 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

20 sites in 3 countries.

Country

City, postcode or hospital

20 sites in 3 countries

Germany10 sites

GSK Investigational Site
Bramsche, 49565
GSK Investigational Site
Erfurt, 99086
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Hürth, North Rhine-Westphalia, 50354
GSK Investigational Site
Leipzig, Brandenburg, 16269
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41236
GSK Investigational Site
Mönchengladbach, 41236
GSK Investigational Site
Rosenheim, Bavaria, 83026
GSK Investigational Site
Schönau am Königssee, Bavaria, 83471
GSK Investigational Site
Wolfsburg, Lower Saxony, 38448

Other trials in Germany

Spain9 sites

GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Boadilla Del Monte (Madrid), 28660
GSK Investigational Site
Leganés, 28911
GSK Investigational Site
Lleida, 25198
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Málaga, Andalusia, 29004
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41013

Other trials in Spain

Italy1 site

GSK Investigational Site
Milan, 20122

Other trials in Italy

About this study

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

Conditions: Diphtheria
Being tested: DTPa-HBV-IPV/Hib, DTaP5-HBV-IPV-Hib, Pneumococcal 13-valent conjugate vaccine
Keywords: Primary immunization, Immunogenicity, Safety, Diphtheria, Tetanus, Acellular pertussis, Hepatitis B, Inactivated poliovirus, Haemophilus influenzae type b
Medical subject headings: Diphtheria, Tetanus, Hepatitis B, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DTPa-HBV-IPV/HibBiological
Also called Infanrix hexa
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-HibBiological
Also called Vaxelis
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 vaccineBiological
Also called Prevenar 13
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

Study groups in NCT04535037
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: DTaP5-HBV-IPV-Hib; Biological: Pneumococcal 13-valent conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA.
Measured: 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)
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.
Measured: 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)
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.
Measured: Throughout the entire period of the study (from Day 1 up to study end [Month 11])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 202125 Jul 2022

First posted1 Sep 2020
Study start26 May 2021
Primary completion25 Jul 2022
Study completion25 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiphtheriaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04535037
Sponsor's protocol ID: 212645
Other IDs: 2019-002988-10, 2019
Status last verified: Aug 2024
First submitted: 27 Aug 2020
Last updated: 27 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Publications

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.
PubMed 38687024

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04535037
Acronym / sponsor ID: 212645
Conditions: Diphtheria
Keywords: Primary immunization, Immunogenicity, Safety, Diphtheria, Tetanus, Acellular pertussis, Hepatitis B, Inactivated poliovirus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 26 May 2021 (actual)
Primary completion: 25 Jul 2022 (actual)
Study completion: 25 Jul 2022 (actual)
First posted: 1 Sep 2020 (actual)
Results: Posted 27 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Infanrix Hexa	Experimental	Biological: DTPa-HBV-IPV/Hib, Biological: Pneumococcal 13-valent conjugate vaccineAll 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.
Vaxelis	Active comparator	Biological: DTaP5-HBV-IPV-Hib, Biological: Pneumococcal 13-valent conjugate vaccineAll 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.

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DTPa-HBV-IPV/HibAlso: Infanrix hexa3 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	Biological	Infanrix Hexa
DTaP5-HBV-IPV-HibAlso: Vaxelis3 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	Biological	Vaxelis
Pneumococcal 13-valent conjugate vaccineAlso: Prevenar 133 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	Biological	Infanrix Hexa, Vaxelis

Primary outcome

Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations at Month 11, Based on Per Protocol Set (PPS)
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
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).
Percentage of Subjects With Anti-PRP Antibody Concentrations Equal to or Above (≥) 5 µg/mL at Month 11, Based on PPS
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA.
Anti-PRP Antibody Concentrations at Month 11, Based on the Exposed Set (ES)
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA.
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥ 5 µg/mL at Month 11, Based on ES
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA.

5 secondary outcomes

Percentage of Subjects With Anti-PRP Antibody Concentration ≥ 0.15 µg/mL
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Throughout the entire period of the study (from Day 1 up to study end [Month 11])

Results and safety

Results posted to the registry on 27 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infanrix Hexa	249	237
Vaxelis	251	233

Primary outcome: Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations at Month 11, Based on Per Protocol Set (PPS)

Time frame: At Month 11 (i.e., 1-month post-booster vaccination). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Infanrix Hexa n = 211	Vaxelis n = 218
Value	11.61 (NA to NA)	12.66 (NA to NA)

Infanrix Hexa vs Vaxelis: Adjusted GMC Ratio: 0.917 (95% CI 0.710 to 1.185)

Population analysed: The analysis was performed on the Per Protocol Set (PPS), which included all eligible subjects who received diphtheria, tetanus and acellular pertussis (DTPa)-combination study vaccines as per protocol, who had anti-PRP results post-vaccination, who complied with vaccination/blood draw intervals, without intercurrent conditions and without prohibited concomitant medication/vaccination and for whom immunogenicity data were available for specific timepoints.

Primary outcome: Percentage of Subjects With Anti-PRP Antibody Concentrations Equal to or Above (≥) 5 µg/mL at Month 11, Based on PPS

Time frame: At Month 11 (i.e., 1-month post-booster vaccination). Number. Unit: Percentage of Participants

Measure	Infanrix Hexa n = 211	Vaxelis n = 218
Value	75.4	81.7

Infanrix Hexa vs Vaxelis: Difference in Percentage: -6.30 (95% CI -14.10 to 1.49)

Population analysed: The analysis was performed on PPS, which included all eligible subjects who received all DTPa-combination study vaccines as per protocol, who had anti-PRP results post-vaccination, who complied with vaccination/blood draw intervals, without intercurrent conditions and without prohibited concomitant medication/vaccination and for whom immunogenicity data were available for specific timepoints.

Primary outcome: Anti-PRP Antibody Concentrations at Month 11, Based on the Exposed Set (ES)

Time frame: At Month 11 (i.e., 1-month post-booster vaccination). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Infanrix Hexa n = 175	Vaxelis n = 228
Value	11.26 (NA to NA)	12.85 (NA to NA)

Population analysed: The analysis was performed on the Exposed Set (ES), which included all vaccinated subjects who were analysed according to the intervention they received at Dose 1 and for whom immunogenicity data were available for specific timepoints.

Primary outcome: Percentage of Subjects With Anti-PRP Antibody Concentrations ≥ 5 µg/mL at Month 11, Based on ES

Time frame: At Month 11 (i.e., 1-month post-booster vaccination). Number. Unit: Percentage of Participants

Measure	Infanrix Hexa n = 175	Vaxelis n = 186
Value	75.4	81.6

Population analysed: The analysis was performed on the ES, which included all vaccinated subjects who were analysed according to the intervention they received at Dose 1 and for whom immunogenicity data were available for specific timepoints.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events (SAEs) were collected throughout the entire period of the study (from Day 1 up to study end [Month 11]). Non Serious AEs (Other AEs) were collected during the 31 days follow-up period after each vaccination (vaccines administered at 2,4 and 12 months of age).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix Hexa	14 of 249 (5.6%)	178 of 249 (71.5%)	0 of 249
Vaxelis	10 of 251 (4%)	199 of 251 (79.3%)	0 of 251

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38687024Martinon-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.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

20 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DTPa-HBV-IPV/Hib, DTaP5-HBV-IPV-Hib and Pneumococcal 13-valent conjugate vaccine in people with Diphtheria, run by GlaxoSmithKline at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations at Month 11, Based on Per Protocol Set (PPS) (time frame: At Month 11 (i.e., 1-month post-booster vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535037, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.