Study of DTaP-IPV-Hep B-PRP T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants

Study Overview
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Brief Summary
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The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months) Secondary Objectives: To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP T and Infanrix®Hexa) one month after the third dose of the primary series. To assess the overall safety in each group one month after each dose of the primary series and through the entire study.

Detailed Description
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The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age.

Official Title
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Immunogenicity Study of DTaP-IPV-Hep B-PRP T Combined Vaccine in Comparison to Infanrix®Hexa, at 2-4-6 Months of Age in Healthy Peruvian Infants

Conditions
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Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B

Intervention / Treatment
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* Biological: DTaP IPV HB PRP T vaccine
* Biological: DTaP-HB-IPV and Haemophilus influenzae type b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Two month old infant (50 to 71 days old) on the day of inclusion, of either gender Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg Mother negative for Hepatitis B surface Antigen (HBsAg) in approximately the last 30 days of pregnancy (≥ 36 weeks of amenorrhea) or in the 30 days post partum Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject's grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate Able to attend all scheduled visits and to comply with all trial procedures Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar. 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 Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received since birth Any vaccination in the 4 weeks preceding the first trial vaccination Any planned vaccination during the trial (until Visit 06), except the study vaccines, rotavirus vaccine and pneumococcal conjugate vaccines Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s) (confirmed either clinically, serologically, or microbiologically) Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s) Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or hepatitis C seropositivity Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination History of seizures Febrile (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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>DTaP-IPV-Hep B-PRP T vaccine group | Biological: DTaP IPV HB PRP T vaccine<br>* 0.5 mL, Intramuscular<br>|
| Active Comparator: Group 2<br>Infanrix® Hexa vaccine group | Biological: DTaP-HB-IPV and Haemophilus influenzae type b<br>* 0.5 mL, Intramuscular<br>* Other names: Infanrix® Hexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP T or Infanrix Hexa™ | Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL. | Day 150 (1 month after dose 3) | 
| Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP T or Infanrix Hexa™ Vaccine. | Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as: Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL. Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL. | Day 150 (1 month after dose 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP T or Infanrix Hexa™ Vaccine. | Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. | Day 150 (1 month after dose 3) | 
| Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP T or Infanrix Hexa™ Vaccine. | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable. | Day 0 up to Day 7 after each injection | 

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