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

Streptococcus Pneumoniae Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594347
• Other study ID #: PNA19
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2007
• Last updated: June 16, 2015
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: June 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: April 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Months

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pneumonia
• Streptococcus Pneumoniae

Intervention

Biological:
• Pneumo 23
Vaccine (Pneumo 23)
• Prevnar
Vaccine (Prevnar)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine		30 days post-vaccination	No

External Links

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