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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594347
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : June 18, 2015
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:
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 or disease Intervention/treatment Phase
Streptococcus Pneumoniae Biological: Pneumo 23 Biological: Prevnar Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : November 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Group A
Pneumo 23
Biological: Pneumo 23
Vaccine (Pneumo 23)

Active Comparator: Group B
Biological: Prevnar
Vaccine (Prevnar)

Primary Outcome Measures :
  1. To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine [ Time Frame: 30 days post-vaccination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00594347

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

Additional Information:
Publications of Results:
Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT00594347     History of Changes
Other Study ID Numbers: PNA19
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Streptococcus pneumoniae

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs