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Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

NCT ID: NCT00853749

Last Updated: 2021-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-05

Study Completion Date

2009-12-16

Brief Summary

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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

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

Conditions

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Invasive Pneumococcal Disease

Keywords

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Immune response pneumococcal conjugate vaccine polysaccharide

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single

All subjects will receive a single dose of 13vPnC

Group Type OTHER

13-valent pneumococcal conjugate vaccine (13vPnC)

Intervention Type BIOLOGICAL

0.5 mL intramuscular injection

Blood draw

Intervention Type PROCEDURE

Collection of 10 mL of blood

Interventions

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13-valent pneumococcal conjugate vaccine (13vPnC)

0.5 mL intramuscular injection

Intervention Type BIOLOGICAL

Blood draw

Collection of 10 mL of blood

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Landspitali University Hospital

Hringbraut, Reykjavik, Iceland

Site Status

Midstod Heilsuverndar barna

Reykjavik, , Iceland

Site Status

Countries

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Iceland

References

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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.

Reference Type DERIVED
PMID: 24300594 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6096A1-3013&StudyName=Immune%20Response%20In%20Children%20Revaccinated%20With%20Pneumococcal%20Conjugate%20Vaccine

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1851012

Identifier Type: OTHER

Identifier Source: secondary_id

2008-006194-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6096A1-3013

Identifier Type: -

Identifier Source: org_study_id