Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar

Sanofi

Status and phase

Completed

Phase 3

Conditions

Streptococcus Pneumoniae

Treatments

Biological: Pneumo 23

Biological: Prevnar

Study type

Interventional

Funder types

Industry

Identifiers

NCT00594347

PNA19

Details and patient eligibility

About

The present study intends to investigate the use as a booster of a dose of sanofi pasteur's Pneumo 23 vaccine in the second year of life following 3-dose priming with Wyeth's Prevnar vaccine. The researchers will use a cohort of subjects who have received 3 doses of Prevnar® at 2, 4, 6 months of age in the context of the clinical study A3L12 on Hexavalent combined vaccine (DTaP-IPV-HB-PRP~T)

Enrollment

339 patients

Sex

All

Ages

12 to 18 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 12 to 18 months on the day of inclusion
Informed consent form signed by the parent/legally acceptable representative and by an independent witness if requested by local Ethics Committee regulation or/and if the parent/legally acceptable representative is illiterate
Child having completed the three-dose primary vaccination of Prevnar® in the hexavalent combined vaccine study (study A3L12).
Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures

Exclusion criteria

Participation in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
Planned participation in another clinical study during the present study period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or to a vaccine containing any of the same substances
Chronic illness at a stage that could interfere with study conduct or completion, in the opinion of the investigator
Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
Receipt of any vaccine in the 4 weeks preceding the study vaccination
Planned receipt of any vaccine in the 4 weeks preceding or following study vaccination
History of seizures Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) antigen or Hepatitis C seropositivity
History of pneumococcal infection (confirmed either clinically, serologically or microbiologically)
Previous booster vaccination against the pneumococcal disease with either the study vaccine(s) or another vaccine
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.