Phase 3 N=89 Other

Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

Invasive Pneumococcal Disease

Bottom Line

View on ClinicalTrials.gov: NCT00853749 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2011

Primary outcome: Primary: Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination — 100.0; 97.3; 100.0; 100.0 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 13-valent pneumococcal conjugate vaccine (13vPnC) (Biological); Blood draw (Procedure)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination	100.0; 97.3; 100.0; 100.0; 100.0; 100.0	—
PRIMARY Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination	98.0; 97.2; 100.0; 100.0; 100.0; 100.0	—
SECONDARY Antibody Response Measured 1 Month After Vaccination (Avidity Assay)	1.42; 4.68; 1.85; 5.85; 2.43; 5.48	—
SECONDARY Antibody Response Measured 1 Month After Vaccination (OPA)	2374; 3765; 11156; 11477; 1651; 1713	—

Summary

The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.

Eligibility Criteria

Inclusion Criteria

Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
Subjects must be in good health as determined by medical history, physical examination and clinical judgment.

Exclusion Criteria

Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
Receipt of immune-globulin within the past 3 months.
Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00853749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.