Immunogenicity of DTaP-IPV-Hep B-PRP T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Study Overview
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Brief Summary
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To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity To assess pre- and post-primary series To assess pre- and post-booster series.

Official Title
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Immunogenicity of DTaP-IPV-Hep B-PRP T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants

Conditions
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Hepatitis B, Polio, Diphtheria, Pertussis

Intervention / Treatment
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* Biological: DTaP-IPV-HB-PRP T vaccine
* Biological: DTaP-IPV//PRP T combined
* Biological: Hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Two-month old infants of either gender on the day of inclusion Born at full term of pregnancy (>=37 weeks) with a birth weight >=2.5 kg Informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received since birth Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination Vaccination planned in the 4 weeks following trial vaccination History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s) Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of seizures Febrile (axillary temperature 37.4°C [rectal equivalent temperature >=38.0°C]) or acute illness on the day of inclusion.

Ages Eligible for Study
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Minimum Age: 50 Days
Maximum Age: 71 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: DTaP-IPV-Hep B-PRP-T<br>Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP T); One dose each at 2, 3, and 4 months of age. | Biological: DTaP-IPV-HB-PRP T vaccine<br>* 0.5 mL, Intramuscular (IM)<br>|
| Active Comparator: Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC<br>Participants will receive 3 vaccinations with DTaP-IPV-PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age. | Biological: DTaP-IPV//PRP T combined<br>* 0.5 mL, IM<br>* Other names: PENTAXIM™;Biological: Hepatitis B vaccine<br>* 0.5 mL, IM<br>* Other names: ENGERIX B®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ + ENGERIX B® Vaccines | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL. | Day 90 post first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ + ENGERIX B® | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP. | Day 90 post first dose | 
| Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP T or PENTAXIM™ + ENGERIX B® | Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil. | Day 90 post first dose | 
| Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP T or PENTAXIM™ + ENGERIX B® | Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90). | Day 0 (pre-vaccination) and Day 30 post-dose 3 | 
| Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP T or PENTAXIM™ + ENGERIX B® | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. | Day 90 (30 Days post-dose 3) | 
| Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP T or PENTAXIM™ + ENGERIX B® | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability | Day 0 to Day 7 post any dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Polio, Diphtheria, Pertussis, H influenzae type b