Brief Title
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Official Title
Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants
Brief Summary
This is a follow-up of Study A3L11 (NCT00404651).
Immunogenicity
- To describe the antibody persistence following a primary series vaccination of either
DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
- To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of
subjects.
Safety
- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Condition
Diphtheria
Intervention
DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
Study Arms / Comparison Groups
DTaP-IPV-Hep B-PRP~T Batch 1
Description: Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
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
881
Start Date
March 2008
Completion Date
July 2009
Primary Completion Date
May 2009
Eligibility Criteria
Inclusion Criteria:
- Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose
primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and
6 months of age
- Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
- Informed Consent Form signed by at least one parent or legal representative and two
mandatory witnesses
- 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 booster
vaccination.
- Planned participation in another clinical trial during the present trial period.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term
systemic corticosteroid therapy.
- 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 booster vaccination.
- Any vaccination planned until the next visit.
- History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae
type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or
microbiologically).
- Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or
hepatitis B infection(s) since the end of participation in Study A3L11.
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular
vaccination.
- Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface
antigen (HbsAg) or Hepatitis C seropositivity.
- Subjects with any related serious adverse event that occurred following the three-dose
primary series administration of the investigational vaccine or of the reference
vaccine in Study A3L11.
- History of seizures.
- Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion
- Known contraindication to further vaccination with a pertussis vaccine, i.e.:
Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not
due to another identifiable cause during the primary series; Inconsolable crying that
occurred for >3 hours within 48 hours following vaccine injection during the primary
series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection
during the primary series; Seizures with or without fever within 3 days following
vaccine injection.
Gender
All
Ages
15 Months - 18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT00654901
Organization ID
A3L21
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur, a Sanofi Company
Verification Date
April 2016