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Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine (REPLAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00853749
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : January 5, 2011
Last Update Posted : January 5, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Invasive Pneumococcal Disease Biological: 13-valent pneumococcal conjugate vaccine (13vPnC) Procedure: Blood draw Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Revaccination With Pneumococcal Conjugate Vaccine - Characterization Of The Immune Response After Polysaccharide
Study Start Date : May 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single
All subjects will receive a single dose of 13vPnC
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL intramuscular injection

Procedure: Blood draw
Collection of 10 mL of blood




Primary Outcome Measures :
  1. 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 [ Time Frame: Day 28 ]
    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.

  2. Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination [ Time Frame: Day 28 ]
    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.


Secondary Outcome Measures :
  1. Antibody Response Measured 1 Month After Vaccination (Avidity Assay) [ Time Frame: Day 28 ]
    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).

  2. Antibody Response Measured 1 Month After Vaccination (OPA) [ Time Frame: Day 28 ]
    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.


Other Outcome Measures:
  1. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination [ Time Frame: Day 28 ]
    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 particpants with available data for the specified blood draw.

  2. Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination [ Time Frame: Day 1 through Day 4 ]
    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). Particpants may have been represented in more than 1 category.

  3. Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination [ Time Frame: Day 1 through Day 4 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853749


Locations
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Iceland
Pfizer Investigational Site
Reykjavik, Iceland, 101
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00853749    
Other Study ID Numbers: 6096A1-3013
B1851012
First Posted: March 2, 2009    Key Record Dates
Results First Posted: January 5, 2011
Last Update Posted: January 5, 2011
Last Verified: December 2010
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Immune response
pneumococcal conjugate vaccine
polysaccharide
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs