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

This study has been completed.
Sponsor:
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00594347
First received: December 19, 2007
Last updated: February 22, 2010
Last verified: February 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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 ]

Enrollment: 339
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Pneumo 23
 Biological: Pneumo 23
Vaccine (Pneumo 23)
Active Comparator: Group B
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
Bangkok, Thailand
KhonKaen, Thailand
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: sanofi pasteur, sanofi aventis
ClinicalTrials.gov Identifier: NCT00594347     History of Changes
Other Study ID Numbers: PNA19
Study First Received: December 19, 2007
Last Updated: February 22, 2010
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Sanofi-Aventis:
Streptococcus pneumoniae

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 17, 2012