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 (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00594347
First received: December 19, 2007
Last updated: January 10, 2014
Last verified: January 2014
  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:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Thailand
Bangkok, Thailand
KhonKaen, Thailand
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00594347     History of Changes
Other Study ID Numbers: PNA19
Study First Received: December 19, 2007
Last Updated: January 10, 2014
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Sanofi:
Streptococcus pneumoniae

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

ClinicalTrials.gov processed this record on September 18, 2014