A Phase 3 interventional study of Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine and Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine in Diphtheria, Tetanus and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in South Africa. Open to participants aged 5 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in HIV-exposed infected infants.
The primary objectives of the study are:
The secondary objectives of the study are:
Male and female infants born from HIV-infected mothers will be tested for HIV infection from birth to 6 weeks of age. HIV infected and HIV uninfected participants will be enrolled into two groups at Day 0. Some infants detected HIV-exposed infected outside of the hospital center facilities and the trial screening procedure may also be enrolled. All participants will receive primary vaccinations with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age and a booster dose at approximately 15 to 18 months of age will receive a booster dose of the Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine.
270 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 53 is below the median of 440 across 243 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
(Screening Criteria for the participants mother)
Inclusion Criteria:
Exclusion Criteria:
HIV exposed and infected infants
Biological: Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
HIV exposed and uninfected infants
Biological: Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
Drug page: DTaP-IPV-HB-PRP-T vaccine
0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
Also known as: Hexaxim®
Drug page: DTaP-IPV-HB-PRP-T vaccine
0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
Also known as: Hexaxim®
Number of Participants with Anti-Pertussis Toxoid (PT) and Anti-Filamentous Hemagglutinin (FHA) Antibody (Ab) Concentrations >= Lower Limit of Quantification (LLOQ) and >=4*LLOQ at Baseline
Anti-PT and anti-FHA Ab concentrations are determined in terms of endotoxin units per millilitre (EU/mL).
Time frame: Day 0 (baseline)
Geometric Means of Anti-Pertussis Toxoid and Anti-Filamentous Hemagglutinin Antibody Concentrations at Baseline
Anti-PT and anti-FHA Ab levels are measured by electrochemiluminescence immunoassay (ECL) and anti-PT and anti-FHA Ab concentrations are determined in terms of EU/mL.
Time frame: Day 0 (baseline)
Geometric Means of Antibody Titers/Concentrations After Primary Series Vaccination
Anti-diphtheria, anti-tetanus, anti-PT and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-polyribosylribitol phosphate (PRP) Ab levels are measured using a Farr-type radioimmunoassay (RIA). Ab concentrations are determined as: anti-diphtheria \>=0.01 international units (IU)/mL, \>=0.1 IU/mL, 1.0 IU/mL, anti-tetanus \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP \>=0.15 microgram (mcg)/mL, \>=1.0 mcg/mL, anti-Poliovirus types 1, 2, and 3 Ab titers \>=8 (1/dilution \[dil\]), Anti-Hep B \>=10 milli (m) IU/mL, and \>=100 mIU/mL.
Time frame: Day 90 (1 month after third dose)
Number of Participants With Seroprotection After Primary Series Vaccination
Seroprotection is determined as: anti-diptheria Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-tetanus Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (\>=LLOQ and \>=4\*LLOQ), anti-PRP Ab concentrations \>=0.15 mcg/mL and \>=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers \>=8 (1/dil), anti-Hep B Ab concentrations \>=10 mIU/mL and \>=100 mIU/mL.
Time frame: Day 90 (1 month after third dose)
Number of Participants with Vaccine Response or Seroconversion After Primary Series Vaccination
Vaccine response is defined for anti-PT and anti-FHA as Ab post-Dose 3 concentrations \>=4\*LLOQ, if pre-Dose (Day 0) Ab concentration is \<4\*LLOQ or 1 month after third dose (Day 90) concentrations \>= pre-Dose Ab concentrations if pre-Dose (Day 0) concentrations \>=4\*LLOQ. Seroconversion for anti-PT and anti-FHA is defined as \>=4-fold Ab concentrations increase from pre-Dose (Day 0) to 1 month after third dose (Day 90).
Time frame: Day 0 (baseline), Day 90 (1 month after third dose)
Geometric Means of Antibody Titers/Concentrations After Booster Vaccination
Anti-diphtheria, anti-tetanus, anti-PT, and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels are measured using a Farr-type RIA. Ab concentrations: anti-diphtheria \>=0.01 IU/mL, \>=0.1 IU/mL, \>=1.0 IU/mL, anti-tetanus \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP \>=0.15 mcg/mL, \>=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers \>=8 (1/dil), anti-Hep B \>=10 mIU/mL, and \>=100 mIU/mL.
Time frame: Day 420 (1 month after booster vaccination)
Number of Participants With Seroprotection After Booster Vaccination
Seroprotection: anti-diphtheria Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-tetanus Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (\>=LLOQ and \>=4\*LLOQ), anti-PRP Ab concentrations \>=0.15 mcg/mL and \>=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers \>=8 (1/dil), and anti-Hep B Ab concentrations \>=10 mIU/mL and \>=100 mIU/mL.
Time frame: Day 420 (1 month after booster vaccination)
Number of Participants With Vaccine Response or Seroconversion After Booster Vaccination
Vaccine response is defined for anti-PT and anti-FHA as \>=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose (Day 420), if pre-Dose (Day 0) Ab concentrations \<4\*LLOQ; or \>=2 fold Ab concentrations increase from pre- dose (Day 0) to 1 month after booster dose (Day 420), if pre-dose (Day 0) Ab concentrations \>=4\*LLOQ. Seroconversion is defined for anti-PT and anti-FHA as \>=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose.
Time frame: Day 0 (baseline), Day 420 (1 month after booster vaccination)
Number of Participants With Booster Response After Booster Vaccination
Booster response is defined for anti-PT and anti-FHA as \>=4 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 420), if pre-booster Ab concentrations \<4\*LLOQ; or \>=2 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 390) if pre-Booster Ab concentrations \>=4\*LLOQ.
Time frame: Day 390 (pre-booster), Day 420 (1 month after booster dose)
Number of Participants With Immediate Unsolicited Adverse Events (AE) After Primary Series Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination.
Time frame: Within 30 minutes after vaccination
Number of Participants With Solicited Injections Site or Systemic Reactions After Primary Series Vaccination
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: injection site tenderness, erythema, and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
Time frame: Within 7 days after vaccination
Number of Participants With Unsolicited Adverse Events After Primary Series Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding serious adverse events (SAEs). Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site.
Time frame: Within 30 days after vaccination
Number of Participants With Serious Adverse Events During the Study
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Time frame: Day 0 to Day 420
Number of Participants With Immediate Unsolicited Adverse Events After Booster Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination.
Time frame: Within 30 minutes after booster vaccination
Number of Participants With Solicited Injection Site or Systemic Reactions After Booster Vaccination
A solicited reaction is an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions: tenderness, erythema, swelling, and extensive limb swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Time frame: Within 7 days after booster vaccination
Number of Participants With Unsolicited Adverse Events After Booster Vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. An unsolicited non-serious AE is an unsolicited AE excluding SAEs. Systemic AEs are all AEs that are not injection site reactions. They therefore include systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination site.
Time frame: Within 30 days after booster vaccination
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
Ran from Jul 2016 to primary completion in Feb 2019, 31 months.
Of 37 industry-sponsored phase 3 interventional studies under Diphtheria, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's 31 months is above that.
Counting every sponsor, half of 37 studies reached it within 12 months; a quarter within 7 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: DTaP-IPV-HB-PRP-T vaccine
Sanofi Pasteur, a Sanofi Company →