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Clinical Trials/EUCTR2019-002585-12-IT
EUCTR2019-002585-12-IT
Active, Not Recruiting
Phase 1

Immunogenicity and Safety of DTaP-IPV-HB-PRP~T Combined Vaccine Given at 3, 5, and 12 Monhs of Age Concomitantly or Sequentially 4CMenB Vaccine in Italian Infants - NA

SANOFI PASTEUR0 sites396 target enrollmentAugust 4, 2020
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ConditionsHaemophilus influenzae type b immunisationMedDRA version: 21.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsHexyon sospensione iniettabile - vaccino coniugato (adsorbito) contro difterite, tetano, pertosse (componente acellulare), epatite B (rDNA), poliomielite (inattivato) ed Haemophilus influenzae di tipo b

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Haemophilus influenzae type b immunisation
Sponsor
SANOFI PASTEUR
Enrollment
396
Status
Active, Not Recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 4, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Aged 76 to 110 days on the day of the first study visit (depending on local practices as per National Immunization Program (NIP))
  • •\- Born to an adult mother (\>\= 18 years of age) (including mothers vaccinated and not vaccinated with Tdap during pregnancy)
  • •\- Born at full term of pregnancy (\>\= 37 weeks) and with a birth weight \>\= 2\.5 kg or born after a gestation period of 32 through 37 weeks with a birth weight \>\= 2\.0 kg and under stable condition defined as: infant who does not require significant medical support or ongoing management for debilitating disease and who have demonstrated a sustained recovery growth curve by the time he/she receives the first dose of the vaccination series
  • •\- Participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and to comply with all trial procedures
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • •2\. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination, except in case of routine vaccines to be administered as per the NIP and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • •3\. Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (Hep B), pneumococcal, meningococcal, or Hib infections or diseases with the study vaccine or another vaccine
  • •4\. Receipt of immunoglobulins, blood or blood\-derived products since birth
  • •5\. Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti\-cancer chemotherapy or radiation therapy since birth; or long\-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
  • •6\. Known personal or maternal history of Hep B (HBsAg) or Hep C seropositivity
  • •7\. History of diphtheria, tetanus, pertussis, poliomyelitis, Hep B, Hib infection, meningococcal infection, or pneumococcal infection, confirmed either clinically, serologically or microbiologically
  • •8\. Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life\-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • •9\. Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s) contraindicating intramuscular (IM) vaccination as assessed by the investigator
  • •10\. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Study to Assess the Immune Response and the Safety Profile of DTaP-IPV-HB-PRP~T Combined Vaccine Given Concomitantly or Sequentially with 4CMenB Vaccine in Italian and Finnish InfantsHaemophilus influenzae type b immunisationMedDRA version: 21.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
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