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

Study Overview
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Brief Summary
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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)

Official Title
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Immunogenicity and Safety of a Booster Dose of Polysaccharide Pneumococcal Vaccine (Pneumo 23®) in 12 to 18 Months-Old Children Primed With Three Doses of Pneumococcal Conjugate Vaccine (Prevnar®) in Thailand.

Conditions
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Streptococcus Pneumoniae

Intervention / Treatment
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* Biological: Pneumo 23
* Biological: Prevnar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Pneumo 23 | Biological: Pneumo 23<br>* Vaccine (Pneumo 23)<br>|
| Active Comparator: Group B<br>Prevnar | Biological: Prevnar<br>* Vaccine (Prevnar)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine |  | 30 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus pneumoniae