Study to Assess the Immune Response and the Safety Profile of DTaP-IPVHB- PRP~T Combined Vaccine Given Concomitantly or Sequentially with 4CMenB Vaccine in Italian Infants

Phase 1

• Conditions: Haemophilus influenzae type b immunisation; MedDRA version: 21.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-002585-12-IT
• Lead Sponsor: SANOFI PASTEUR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-04
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 396

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
11. History of seizures
12. Participants in an emergency setting or hospitalized involuntarily
13. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature >= 38.0°C [>= 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
15. Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified