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

Phase 3

Completed

• Conditions: Streptococcus Pneumoniae
• Interventions: Biological: Prevnar; Biological: Pneumo 23

• Registration Number: NCT00594347
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Primary Completion: 2008-03
• Study Completion: 2009-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Prevnar	Prevnar
Group A	Pneumo 23	Pneumo 23

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine	30 days post-vaccination