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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00514709
Other study ID # AL204
Secondary ID
Status Completed
Phase Phase 3
First received August 9, 2007
Last updated November 18, 2013
Start date September 2007
Est. completion date April 2009

Study information

Verified date November 2013
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Philippines: Department of Health
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Completed
Enrollment 1843
Est. completion date April 2009
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 18 Months
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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
DTaP-HB PRP~T Combined Vaccine
0.5 mL, Intramuscular (IM)
DTaP-HB-PRP~T vaccine
0.5 mL, IM
Oral Polio Vaccine
Oral co-administered with study vaccine.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) 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.
Day 0 (pre-vaccination) and Day 28 post-booster vaccination No
Secondary Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) 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. Day 28 post-vaccination No
Secondary 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) 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.
Day 0 to Day 7 after vaccination No
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