Clinical trial NCT00853749: Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Official title: REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Invasive Pneumococcal Disease
Keywords: Immune response
pneumococcal conjugate vaccine
polysaccharide
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-03-02
Enrollment: 89
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: OTHER

Brief 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.

Detailed description: Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

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.

Primary outcomes:
measure: 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
timeFrame: Day 28
measure: Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
timeFrame: Day 28
Secondary outcomes:
measure: Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
timeFrame: Day 28
measure: Antibody Response Measured 1 Month After Vaccination (OPA)
timeFrame: Day 28
Other outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
timeFrame: Day 28
measure: Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
timeFrame: Day 1 through Day 4
measure: Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
timeFrame: Day 1 through Day 4
Locations:
city: Hringbraut
country: Iceland
facility: Landspitali University Hospital
state: Reykjavik
city: Reykjavik
country: Iceland
facility: Midstod Heilsuverndar barna
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sigurdardottir ST, Center KJ, Davidsdottir K, Arason VA, Hjalmarsson B, Elisdottir R, Ingolfsdottir G, Northington R, Scott DA, Jonsdottir I. Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children. Vaccine. 2014 Jan 9;32(3):417-24. doi: 10.1016/j.vaccine.2013.11.029. Epub 2013 Dec 2.