Lot Consistency Study of DTaP-IPV-HB-PRP T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Study Overview
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Brief Summary
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The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP T vaccine is consistent. The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series. The secondary objectives are: To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series To assess the overall safety in each group one month after the third dose of the primary series.

Official Title
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Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants

Conditions
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Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis

Intervention / Treatment
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* Biological: DTaP-IPV-HB-PRP T vaccine
* Biological: DTaP-IPV-HB-PRP T vaccine
* Biological: DTaP-IPV-HB-PRP T vaccine
* Biological: DTaP-HBV-IPV vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Two months old infants 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 one or both parents or by the guardian and two independent witnesses 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 four weeks preceding the (first) trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency 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 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 four weeks preceding the first trial visit Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s) Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of seizures Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Ages Eligible for Study
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Minimum Age: 2 Months

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>Participants receive vaccine Batch A | Biological: DTaP-IPV-HB-PRP T vaccine<br>* 0.5 mL, intramuscular (IM)<br>|
| Experimental: Group 2<br>Participants receive vaccine Batch B | Biological: DTaP-IPV-HB-PRP T vaccine<br>* 0.5 mL, IM<br>|
| Experimental: Group 3<br>Participants receive vaccine Batch C | Biological: DTaP-IPV-HB-PRP T vaccine<br>* 0.5 mL, IM<br>|
| Active Comparator: Group 4<br>Participants receive Infanrix hexa™ | Biological: DTaP-HBV-IPV vaccine<br>* 0.5 mL, IM<br>* Other names: INFANRIX®HEXA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP T or Infanrix Hexa™ Vaccine | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies. | Day 150 (one month post-dose 3) | 
| Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP T or Infanrix Hexa™ Vaccine. | Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3. | Day 150 (one month post-dose 3) | 
| Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP T or Infanrix Hexa™ Vaccine | Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions). | Day 150 (one month post-dose 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP T Vaccine or Infanrix Hexa™ Vaccine | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). | Day 150 (one month post-dose 3) | 
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP T Vaccine or Infanrix Hexa™ Vaccine | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability | Day 0 (pre-each vaccination) up to 7 days post-each dose | 

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