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

NCT00594347 | Completed Phase 3 DMC

• 1 other identifier: PNA19
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 2

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)

Conditions

Streptococcus Pneumoniae

Keywords

Streptococcus pneumoniae

Outcome Measures

Primary Outcomes (1)

• To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine

  30 days post-vaccination

Study Arms (2)

Group A

EXPERIMENTAL

Pneumo 23

Biological: Pneumo 23

Group B

ACTIVE COMPARATOR

Prevnar

Biological: Prevnar

Interventions

Pneumo 23 BIOLOGICAL

Vaccine (Pneumo 23)

Group A

Prevnar BIOLOGICAL

Vaccine (Prevnar)

Group B

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

KhonKaen, Thailand

Location

Related 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 pneumococcal conjugate vaccine. Hum Vaccin Immunother. 2014;10(7):1859-65. doi: 10.4161/hv.28642.

  PMID: 25424793 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: January 15, 2008
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2009
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

TH (2)