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

NCT ID: NCT00303316

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-09-30

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.

Conditions

Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PENTAXIM™ and ENGERIX B® Vaccine Group

Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series)

Group Type: ACTIVE_COMPARATOR

DTaP-IPV//PRP~T combined vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

DTacP IPV HepB PRP-T Combined Vaccine Group

Participant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02.

Group Type: EXPERIMENTAL

DTaP-IPV//PRP~T combined vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

DTaP-IPV//PRP~T combined vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

DTaP-IPV//PRP~T combined vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

PENTAXIM™; PENTAXIM™

Eligibility Criteria

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.

• Minimum Eligible Age: 510 Days
• Maximum Eligible Age: 578 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Córdoba, Córdoba Province, Argentina

Countries

Argentina

References

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//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a.

Reference Type: RESULT

PMID: 22157567 (View on PubMed)

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

A3L16

Identifier Type: -

Identifier Source: org_study_id