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

• Conditions: Healthy volunteers: prevention of invasive disease caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F and prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-005337-45-Outside-EU/EEA
• Lead Sponsor: SANOFI PASTEUR SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Last Update Posted: 14 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

1. Aged 12 to 18 months on the day of inclusion
2. 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
3. Child having completed the three-dose primary vaccination of Prevnar® in the
hexavalent combined vaccine study (study A3L12)
4. Subjects and parent/guardian able to attend all scheduled visits and comply with
all study procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 408
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participation in another clinical study investigating a vaccine, drug, medical
device, or a medical procedure in the 4 weeks preceding the study vaccination
2. Planned participation in another clinical study during the present study period
3. Known or suspected congenital or acquired immunodeficiency
immunosuppressive therapy such as long-term systemic corticosteroids therapy
4. 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
5. Chronic illness at a stage that could interfere with study conduct or completion, in
the opinion of the investigator
6. Receipt of blood or blood-derived products since birth that might interfere with
the assessment of immune response
7. Receipt of any vaccine in the 4 weeks preceding the first study vaccination
8. Planned receipt of any vaccine in the 4 weeks preceding or following study
vaccination
9. History of seizures
10. Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB)
antigen or Hepatitis C seropositivity
11. History of pneumococcal infection (confirmed either clinically, serologically or
microbiologically)
12. Previous booster vaccination against the pneumococcal disease with either the
study vaccine(s) or another vaccine
13. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
inclusion contraindicating IM vaccination
14. 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 clinical trial of medicinal product
• Study Design: Not specified