A Phase 4 interventional study of DTPa-HBV-IPV/Hib and DTaP5-HBV-IPV-Hib in Diphtheria, sponsored by GlaxoSmithKline. Completed at 20 sites in 3 countries. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention
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.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 500 is above the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
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.
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
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.
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
Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA.
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)
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.
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)
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.
Time frame: Throughout the entire period of the study (from Day 1 up to study end [Month 11])
| Milestone | Infanrix Hexa | Vaxelis |
|---|---|---|
| Started | 249 | 251 |
| Completed | 237 | 233 |
| Not completed | 12 | 18 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 8 | 9 |
| Withdrew: Migrated / moved from the study area | 1 | 4 |
| Withdrew: Other | 2 | 5 |
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).
| μg/mL | Infanrix Hexa | Vaxelis |
|---|---|---|
| Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations at Month 11, Based on Per Protocol Set (PPS) | 11.61 (NA to NA) | 12.66 (NA to NA) |
The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA.
| Percentage of Participants | Infanrix Hexa | Vaxelis |
|---|---|---|
| Percentage of Subjects With Anti-PRP Antibody Concentrations Equal to or Above (≥) 5 µg/mL at Month 11, Based on PPS | 75.4 | 81.7 |
Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA.
| μg/mL | Infanrix Hexa | Vaxelis |
|---|---|---|
| Anti-PRP Antibody Concentrations at Month 11, Based on the Exposed Set (ES) | 11.26 (NA to NA) | 12.85 (NA to NA) |
The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA.
| Percentage of Participants | Infanrix Hexa | Vaxelis |
|---|---|---|
| Percentage of Subjects With Anti-PRP Antibody Concentrations ≥ 5 µg/mL at Month 11, Based on ES | 75.4 | 81.6 |
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.
| Percentage of Participants | Infanrix Hexa | Vaxelis |
|---|---|---|
| At month 3 | 79.8 (73.79 to 84.99) | 100 (98.41 to 100) |
| At Month 10 | 61.2 (54.14 to 67.86) | 94.4 (90.50 to 97.10) |
| At Month 11 | 99.5 (97.39 to 99.99) | 99.5 (97.47 to 99.99) |
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.
| Percentage of Participants | Infanrix Hexa | Vaxelis |
|---|---|---|
| At Month 3 | 30.5 (24.41 to 37.18) | 92.2 (87.91 to 95.30) |
| At Month 10 | 13.1 (8.82 to 18.49) | 69.0 (62.35 to 75.08) |
| At Month 11 | 97.2 (93.91 to 98.95) | 94.5 (90.58 to 97.12) |
Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA.
| μg/mL | Infanrix Hexa | Vaxelis |
|---|---|---|
| At Month 3 | 0.5 (0.41 to 0.62) | 11.3 (9.35 to 13.60) |
| At Month 10 | 0.2 (0.19 to 0.28) | 1.9 (1.56 to 2.26) |
| At Month 11 | 12.0 (9.96 to 14.34) | 12.9 (10.75 to 15.55) |
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.
| Participants | Infanrix Hexa | Vaxelis |
|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) | 178 | 199 |
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.
| Participants | Infanrix Hexa | Vaxelis |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 14 | 10 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infanrix Hexa | 0/249 (0%) | 14/249 (5.6%) | 178/249 (71.5%) |
| Vaxelis | 0/251 (0%) | 10/251 (4%) | 199/251 (79.3%) |
| Event | Infanrix Hexa | Vaxelis |
|---|---|---|
| BronchiolitisInfections and infestations | 2/249 | 3/251 |
| Respiratory syncytial virus bronchiolitisInfections and infestations | 1/249 | 3/251 |
| PyrexiaGeneral disorders | 2/249 | 0/251 |
| Urinary tract infectionInfections and infestations | 2/249 | 0/251 |
| SeizureNervous system disorders | 2/249 | 0/251 |
| Pyelonephritis acuteInfections and infestations | 0/249 | 2/251 |
| HydroceleCongenital, familial and genetic disorders | 1/249 | 0/251 |
| DiarrhoeaGastrointestinal disorders | 1/249 | 0/251 |
| VomitingGastrointestinal disorders | 1/249 | 0/251 |
| Abscess neckInfections and infestations | 1/249 | 0/251 |
| Event | Infanrix Hexa | Vaxelis |
|---|---|---|
| PyrexiaGeneral disorders | 103/249 | 132/251 |
| IrritabilityPsychiatric disorders | 31/249 | 37/251 |
| Upper respiratory tract infectionInfections and infestations | 18/249 | 20/251 |
| DiarrhoeaGastrointestinal disorders | 15/249 | 16/251 |
| ConjunctivitisInfections and infestations | 14/249 | 14/251 |
| COVID-19Infections and infestations | 14/249 | 9/251 |
| NasopharyngitisInfections and infestations | 6/249 | 14/251 |
| RestlessnessPsychiatric disorders | 8/249 | 13/251 |
| GastroenteritisInfections and infestations | 9/249 | 10/251 |
| ConstipationGastrointestinal disorders | 3/249 | 9/251 |
| Age, Continuous(Weeks) | Infanrix Hexa | Vaxelis | Total |
|---|---|---|---|
| Mean | 8.6 ± 1.17 | 8.6 ± 1.24 | 8.6 ± 1.20 |
| Sex: Female, Male(Participants) | Infanrix Hexa | Vaxelis | Total |
|---|---|---|---|
| Female | 105 | 135 | 240 |
| Male | 144 | 116 | 260 |
| Race/Ethnicity, Customized(Participants) | Infanrix Hexa | Vaxelis | Total |
|---|---|---|---|
| Black or African American | 1 | 2 | 3 |
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian - Central / South Asian Heritage | 0 | 1 | 1 |
| Asian - East Asian Heritage | 1 | 0 | 1 |
| Asian - South East Asian Heritage | 0 | 1 | 1 |
| White - Arabic / North African Heritage | 5 | 4 | 9 |
| White - Caucasian / European Heritage | 236 | 235 | 471 |
| Other-Unspecified | 5 | 6 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · www.gsk-studyregister.com
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine