Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

Invasive Pneumococcal Disease Clinical Trial

— REPLAY  

Official title:

REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853749
• Other study ID #: 6096A1-3013
• Secondary ID: B18510122008-006
• Status: Completed
• Phase: Phase 3
• Start date: May 5, 2009
• Est. completion date: December 16, 2009

Study information

• Verified date: October 2021
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 16, 2009
• Est. primary completion date: December 16, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL intramuscular injection

Procedure:
• Blood draw
Collection of 10 mL of blood

Locations

Country	Name	City	State
Iceland	Landspitali University Hospital	Hringbraut	Reykjavik
Iceland	Midstod Heilsuverndar barna	Reykjavik

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	Pfizer

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination	Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw.	Day 28
Other	Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination	Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.	Day 1 through Day 4
Other	Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination	Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.	Day 1 through Day 4
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	Percentage of participants achieving predefined antibody threshold = 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.	Day 28
Primary	Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers = 1:8 Measured 1 Month After Vaccination	Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.	Day 28
Secondary	Antibody Response Measured 1 Month After Vaccination (Avidity Assay)	Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).	Day 28
Secondary	Antibody Response Measured 1 Month After Vaccination (OPA)	Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	Day 28

External Links

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