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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00654901
Other study ID # A3L21
Secondary ID
Status Completed
Phase Phase 3
First received April 3, 2008
Last updated May 6, 2013
Start date March 2008
Est. completion date July 2009

Study information

Verified date May 2013
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 881
Est. completion date July 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Months to 18 Months
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
0.5 mL, Intramuscular
Infanrix Hexa™
0.5 mL, Intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA. Day 0 (pre-booster) and Day 30 (one month post-booster) No
Primary Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine Antibody persistence and immunogenicity response:
Level 1: = 10 mIU/mL for hepatitis B (Hep B), = 0.15 µg/mL for Haemophilus influenzae type b (PRP), and = 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: = 100 mIU/mL (Hep B), = 1.0 µg/mL (PRP), and = 0.1 IU/mL (D and T) Level 3, = 1.0 IU/mL (D and T). Anti-polio titers were defined as = 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Day 0 (pre-booster) and Day 30 (one month post-booster) No
Primary Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, = 5cm; Extensive swelling of limb; Pyrexia, = 39.6ºC; Vomiting = 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses = feeds or most feeds; Irritability, inconsolable.
Days 0 up to 7 after any injection No
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