Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP T Combined Vaccine or Tritanrix-HepB/Hib™

Study Overview
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Brief Summary
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The present trial is a follow-up of AL203 study (NCT00343889). Primary Objectives: To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine [OPV]). Secondary Objective: To describe the safety profile of a booster dose of DTaP-HB-PRP T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.

Detailed Description
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Study participants will receive a booster vaccination of DTaP-HB-PRP T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).

Official Title
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Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants

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

Intervention / Treatment
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* Biological: DTaP-HB-PRP T vaccine
* Biological: Tritanrix-HepB/Hib™
* Biological: Oral Polio Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive) Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) 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 trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months Known 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 trial vaccination Vaccination planned in the 4 weeks following the trial vaccination Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically) Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination Serious adverse event related to any vaccination in the AL203 study.

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: Group 1<br>DTaP-Hep B-PRP-T + OPV vaccine group | Biological: DTaP-HB-PRP T vaccine<br>* 0.5 mL, Intramuscular<br>Biological: Oral Polio Vaccine<br>* 0.5 mL, Oral<br>|
| Active Comparator: Group 2<br>Tritanrix-HepB/Hib™ + OPV vaccine group | Biological: Tritanrix-HepB/Hib™<br>* 0.5 mL, Intramuscular<br>Biological: Oral Polio Vaccine<br>* 0.5 mL, Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio. | 28 Days post-vaccination | 
| Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination | Day 28 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable. | 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, Hepatitis B Hansenula (HB), Haemophilus influenzae type b