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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Diphtheria

Hepatitis B

Pertussis

Tetanus

Treatments

Biological: DTaP-IPV//PRP~T combined vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00303316

A3L16

Details and patient eligibility

About

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.

Enrollment

458 patients

Sex

All

Ages

510 to 578 days old

Volunteers

Accepts Healthy Volunteers

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.