NCT00918580

Brief Summary

This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2009

Typical duration for phase_3

Geographic Reach
7 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

March 1, 2014

Enrollment Period

3.3 years

First QC Date

June 9, 2009

Results QC Date

March 17, 2014

Last Update Submit

March 17, 2014

Conditions

Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2

    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.

    1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2

Secondary Outcomes (7)

  • Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1

    Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1

  • Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2

    Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2

  • Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2

    Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2

  • Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody

    Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2

  • Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2

    1 year after 13vPnC Dose 2

  • +2 more secondary outcomes

Other Outcomes (4)

  • Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1

    Within 7 days after 13vPnC Dose 1

  • Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2

    Within 7 days after 13vPnC Dose 2

  • Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1

    Within 7 days after 13vPnC Dose 1

  • +1 more other outcomes

Study Arms (1)

1

EXPERIMENTAL
Biological: 13-valent Pneumoccocal Conjugate Vaccine

Interventions

13-valent Pneumoccocal Conjugate VaccineBIOLOGICAL

2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.

Also known as: 13vPnC
1

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female subject between the ages of \>=6 to \<18 years.
  • Diagnosis of SCD
  • vPS vaccination at least 6 months prior to enrollment.

You may not qualify if:

  • Previous vaccination with pneumococcal conjugate vaccine.
  • Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202-3830, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

Location

Pfizer Investigational Site

The Bronx, New York, 10467, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Cairo, Cairo Governorate, 11361, Egypt

Location

Pfizer Investigational Site

Cairo, Cairo Governorate, 11511, Egypt

Location

Pfizer Investigational Site

Paris, 75015, France

Location

Pfizer Investigational Site

Orbassano (TO), 10043, Italy

Location

Pfizer Investigational Site

Roma, 00165, Italy

Location

Pfizer Investigational Site

Beirut, Lebanon, 2833-7401, Lebanon

Location

Pfizer Investigational Site

Beirut, Lebanon

Location

Pfizer Investigational Site

Riyadh, Saudi, Saudi Arabia

Location

Pfizer Investigational Site

Manchester, Cheshire, M27 4HA, United Kingdom

Location

Pfizer Investigational Site

London, United Kingdom, E1 1BB, United Kingdom

Location

Pfizer Investigational Site

London, SE1 7RH, United Kingdom

Location

Pfizer Investigational Site

London, SE1 9RT, United Kingdom

Location

Pfizer Investigational Site

London, SE5 9RS, United Kingdom

Location

Pfizer Investigational Site

London, SW17 0RE, United Kingdom

Location

Related Links

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 21, 2014

Results First Posted

April 21, 2014

Record last verified: 2014-03

Locations

EG(2)FR(1)GB(6)US(5)IT(2)SA(1)LE(2)