Hepatitis B Clinical Trial
Official title:
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
Verified date | September 2013 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Philippines: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 362 |
Est. completion date | March 2009 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Months to 18 Months |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
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