Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

Phase 3

Completed

Interventions: Biological: DTaP-HB PRP~T Combined Vaccine
Biological: DTaP-HB-PRP~T vaccine
Biological: Oral Polio Vaccine

Brief Summary: DTaP-HB-PRP\~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.

Primary Objectives:

* To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.

* To describe the effect of a booster dose of DTaP-HB-PRP\~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.

Secondary Objective:

* To describe the safety profile of the booster dose of the DTaP-HB-PRP\~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

Detailed Description: This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP\~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP\~T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881).

Recruitment & Eligibility

Inclusion Criteria

Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive)
Participated in the AL201 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, and received hepatitis B vaccine at birth
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 IM vaccination
Serious adverse event related to any vaccination in the AL201 study.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)	Day 0 (pre-vaccination) and Day 28 post-booster vaccination	Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) 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; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)	Day 0 up to Day 7 after vaccination	Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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.
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)	Day 0 (pre-vaccination) and Day 28 post-vaccination	Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.