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

Hepatitis B Clinical Trial

Official title:

Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303316
• Other study ID #: A3L16
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2006
• Last updated: January 18, 2013
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: January 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: September 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 510 Days to 578 Days

Eligibility

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.

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.

Study Design

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

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis B
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• DTaP-IPV//PRP~T combined vaccine
0.5 mL, Intramuscular
• DTaP-IPV//PRP~T combined vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	Day 0 (Before booster vaccination)	No
Primary	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.	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.	Day 30 Post-booster Vaccination	No
Primary	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.	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.	Day 0 (pre-booster) and Day 30 post-booster	No
Secondary	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™	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.	Day 0 up to Day 30 post-booster vaccination	No

External Links

•   Link
•   Link