Study of DTaP-IPV-Hep B-PRP T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Study Overview
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Brief Summary
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Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Secondary Objectives: To describe in each group the immunogenicity parameters one month after the three-dose primary series. To describe safety profile after each vaccination in both groups.

Official Title
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Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

Conditions
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Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Poliomyelitis

Intervention / Treatment
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* Biological: DTaP-IPV-HB-PRP T
* Biological: DTaP-IPV//PRP T combined vaccine & Recombinant hep B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Infant of either gender, aged 50 to 70 days inclusive Mother is negative for HBsAg Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg Written informed consent form signed by at least one parent or by another legal representative and an independent witness Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial. Exclusion Criteria : Axillary temperature ≥37.1°C on the day of inclusion Current or planned enrolment in another clinical trial during the clinical trial period Known mother's history of Human Immunodeficiency Virus (HIV) infection Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days) Receipt of blood-derived products since birth Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial Occurrence of seizures since birth Hypersensitivity to any of the vaccine components Coagulopathy contraindicating intramuscular injection History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections Vaccination within the last 4 weeks.

Ages Eligible for Study
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Minimum Age: 50 Days
Maximum Age: 70 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: 1<br>DTaP IPV HB-PRP T vaccine group | Biological: DTaP-IPV-HB-PRP T<br>* 0.5 mL, Intramuscular<br>|
| Active Comparator: 2<br>PENTAXIM™ and ENGERIX B® vaccines group | Biological: DTaP-IPV//PRP T combined vaccine & Recombinant hep B vaccine<br>* 0.5 mL, Intramuscular (right and left thighs, respectively)<br>* Other names: ENGERIX B® PEDIATRICO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ and ENGERIX B® | Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination. | 1 month post last vaccination | 
| Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ and ENGERIX B® | Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination. | Day 150 (1 month post-vaccination 3) | 
| Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ and ENGERIX B® | Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150). | Day 150 (1 month post-vaccination 3) | 
| Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ and ENGERIX B® | Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150). | Day 150 (1 month post-vaccination 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ | Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP T and PENTAXIM™ injection sites | Day 0 up to Day 7 post-vaccination | 
| Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP T or ENGERIX B® | Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP T and ENGERIX B® injection sites. | Day 0 up to Day 7 post-vaccination | 
| Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP T or PENTAXIM™ and ENGERIX B® | Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination. Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry. | Day 0 up to Day 7 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphtheria, Tetanus, Pertussis, Whooping cough, Hepatitis B, Poliomyelitis, Haemophilus influenzae type b