Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP T Combined Vaccine in Healthy Turkish Infants

Study Overview
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Brief Summary
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This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP T or PENTAXIM™ and ENGERIX B®. To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP T. Safety - To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP T.

Official Title
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Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants

Conditions
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Diphtheria, Polio, Pertussis, Hepatitis B

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age. Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive). 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 booster 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 in the last 3 months. Any vaccination in the 4 weeks preceding the booster vaccination. Any vaccination planned until second Visit. History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically). Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s). Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination. Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055). Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion. Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature > 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for > 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

Ages Eligible for Study
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Minimum Age: 15 Months
Maximum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTaP-IPV-Hep B-PRP T Vaccine Group<br>Participants received a primary series of 3 vaccinations with DTaP-IPV-Hep B-PRP T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-HepB-PRP T at 15 to 18 months of age in the present study | Biological: DTaP-IPV-HB-PRP T vaccine<br>* 0.5 mL, intramuscular (IM)<br>|
| Active Comparator: Pentaxim™ + Engerix B™ Vaccines Group<br>Participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-Hep B-PRP T at 15 to 18 months of age in the present study. | Biological: DTaP-IPV-HB-PRP T vaccine<br>* 0.5 mL, intramuscular (IM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP T or Pentaxim™ + Engerix B Vaccine™ | Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA. | Day 0 before and Day 30 Post-booster vaccination | 
| Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP T | Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). | Day 0 before and Day 30 post-booster vaccination | 
| Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP T | Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable. | Day 0 up to Day 7 post-booster vaccination | 

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