Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar
Primary Purpose
Streptococcus Pneumoniae
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Pneumo 23
Prevnar
Sponsored by
About this trial
This is an interventional prevention trial for Streptococcus Pneumoniae focused on measuring Streptococcus pneumoniae
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Pneumo 23
Prevnar
Outcomes
Primary Outcome Measures
To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine
Secondary Outcome Measures
Full Information
NCT ID
NCT00594347
First Posted
December 19, 2007
Last Updated
June 16, 2015
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00594347
Brief Title
Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcus Pneumoniae
Keywords
Streptococcus pneumoniae
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
339 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Pneumo 23
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Prevnar
Intervention Type
Biological
Intervention Name(s)
Pneumo 23
Intervention Description
Vaccine (Pneumo 23)
Intervention Type
Biological
Intervention Name(s)
Prevnar
Intervention Description
Vaccine (Prevnar)
Primary Outcome Measure Information:
Title
To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine
Time Frame
30 days post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Bangkok
Country
Thailand
City
KhonKaen
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
25424793
Citation
Thisyakorn U, Chokephaibulkit K, Kosalaraksa P, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S. Immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine as a booster dose in 12- to 18-month-old children primed with 3 doses of 7-valent pneumococcal conjugate vaccine. Hum Vaccin Immunother. 2014;10(7):1859-65. doi: 10.4161/hv.28642.
Results Reference
result
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar
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