NCT00269672

Brief Summary

There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
915

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

August 5, 2010

Status Verified

August 1, 2010

Enrollment Period

1.4 years

First QC Date

December 21, 2005

Last Update Submit

August 4, 2010

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Keywords

vaccine

Outcome Measures

Primary Outcomes (1)

  • Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.

Secondary Outcomes (2)

  • Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).

  • Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.

Interventions

13-valent Pneumococcal Conjugate VaccineBIOLOGICAL

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male and female adults 65 years of age and older.
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study.
  • Expected to be available for the duration of the trial (up to approximately 13 months).

You may not qualify if:

  • Received previous immunization with 23vPS.
  • Serious chronic disorders including metastatic malignancy
  • Known or suspected hypersensitivity to any vaccine or vaccine components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Juergens C, de Villiers PJ, Moodley K, Jayawardene D, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial. Hum Vaccin Immunother. 2014;10(5):1343-53. doi: 10.4161/hv.27998. Epub 2014 Feb 27.

    PMID: 24576885DERIVED

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

September 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

August 5, 2010

Record last verified: 2010-08