Brief Title
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
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
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).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
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
Condition
Diphtheria
Intervention
DTaP-HB-PRP~T vaccine
Study Arms / Comparison Groups
Group 1
Description: DTaP-Hep B-PRP-T + OPV vaccine group
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
362
Start Date
September 2007
Completion Date
March 2009
Primary Completion Date
September 2008
Eligibility Criteria
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.
Gender
All
Ages
15 Months - 18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Philippines
Location Countries
Philippines
Administrative Informations
NCT ID
NCT00534833
Organization ID
AL205
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
September 2013