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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-04-30

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)

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Detailed Description

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Conditions

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Streptococcus Pneumoniae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Pneumo 23

Group Type EXPERIMENTAL

Pneumo 23

Intervention Type BIOLOGICAL

Vaccine (Pneumo 23)

Group B

Prevnar

Group Type ACTIVE_COMPARATOR

Prevnar

Intervention Type BIOLOGICAL

Vaccine (Prevnar)

Interventions

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Pneumo 23

Vaccine (Pneumo 23)

Intervention Type BIOLOGICAL

Prevnar

Vaccine (Prevnar)

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes