Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants

Phase 3

Completed

• Conditions: Diphtheria; Hepatitis B; Tetanus; Pertussis; Poliomyelitis
• Interventions: Biological: DTaP-IPV//PRP~T combined vaccine

• Registration Number: NCT00303316
• Lead Sponsor: Sanofi

Brief Summary

This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series.

Primary Objective:

To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity.

Secondary objective:

To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-16
• Primary Completion: 2007-04
• Study Completion: 2007-09
• Results First Submitted: 2012-12-11
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-18
• Last Update Submitted: 2013-01-18
• Results First Posted: 2013-02-22
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

• Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)
• Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age
• Written informed consent form signed by at least one parent or by a legal representative and an independent witness
• Able to attend all scheduled visits and to comply with all trial procedures.

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Exclusion Criteria

• Participation in another clinical trial in the four weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroids 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 six months
• Any vaccination in the four weeks preceding the trial
• Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series
• History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically)
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
• History of seizures
• Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion
• Known contraindication to further vaccination with a pertussis vaccine such as:
• Encephalopathy; Inconsolable crying for >3 hours within 48 hours following vaccine injection
• Hypotonic hyporesponsive episode within 48 hours following vaccine injection
• Seizures with or without fever within three days following vaccine injection
• Axillary temperature >39.4°C or equivalent rectal temperature > 40.0°C within 48 hours following vaccine injection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PENTAXIM™ and ENGERIX B® Vaccine Group	DTaP-IPV//PRP~T combined vaccine	Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series)
DTacP IPV HepB PRP-T Combined Vaccine Group	DTaP-IPV//PRP~T combined vaccine	Participant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02.

Primary Outcome Measures

Name	Time	Method
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.	Day 0 (Before booster vaccination)	Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.	Day 0 (pre-booster) and Day 30 post-booster	Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.	Day 30 Post-booster Vaccination	Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™	Day 0 up to Day 30 post-booster vaccination	Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.; Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.