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

Phase 3

Completed

Conditions: Tetanus
Pertussis
Hepatitis B
Diphtheria
Haemophilus Influenzae Type b

Interventions: Biological: DTaP-HB-PRP~T vaccine
Biological: Tritanrix-HepB/Hib™
Biological: Oral Polio Vaccine

Brief Summary: 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: 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Group 1	DTaP-HB-PRP~T vaccine	DTaP-Hep B-PRP-T + OPV vaccine group
Group 1	Oral Polio Vaccine	DTaP-Hep B-PRP-T + OPV vaccine group
Group 2	Tritanrix-HepB/Hib™	Tritanrix-HepB/Hib™ + OPV vaccine group
Group 2	Oral Polio Vaccine	Tritanrix-HepB/Hib™ + OPV vaccine group

Primary Outcome Measures

Name	Time	Method
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	Day 28 post-vaccination	Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination
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	28 Days post-vaccination	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.

Secondary Outcome Measures

Name	Time	Method
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	Day 0 up to Day 7 post-vaccination	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.