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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00594347

Purpose

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)

Condition	Intervention	Phase
Streptococcus Pneumoniae	Biological: Pneumo 23 Biological: Prevnar	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine [ Time Frame: 30 days post-vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment:	408
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Pneumo 23	Biological: Pneumo 23 Vaccine (Pneumo 23)
Group B: Active Comparator Prevnar	Biological: Prevnar Vaccine (Prevnar)

Eligibility

Ages Eligible for Study:	12 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594347

Locations

Thailand

KhonKaen, Thailand

Bangkok, Thailand

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi aventis ( sanofi pasteur )
Study ID Numbers:	PNA19
Study First Received:	December 19, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00594347
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Sanofi-Aventis:

Streptococcus pneumoniae

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on January 16, 2009