NCT00492557

Brief Summary

The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,185

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 17, 2012

Completed
Last Updated

February 17, 2012

Status Verified

January 1, 2012

Enrollment Period

5 months

First QC Date

June 26, 2007

Results QC Date

January 17, 2012

Last Update Submit

January 17, 2012

Conditions

Pneumococcal Infections

Keywords

Pneumococcal DiseasePneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (2)

  • TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)

    Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.

    Baseline and 1 month after TIV vaccination

  • 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)

    IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

    1 month after 13vPnC vaccination

Other Outcomes (2)

  • Percentage of Participants With Pre-specified Local Reactions

    Days 1 through 14 after 13vPnC vaccination

  • Percentage of Participants With Pre-specified Systemic Events

    Days 1 through 14 after 13vPnC vaccination

Study Arms (2)

13vPnC+TIV Followed by Placebo 1 month later

EXPERIMENTAL
Biological: 13-valent pneumococcal conjugate vaccine

Placebo+TIV Followed by 13vPnC 1 month later

ACTIVE COMPARATOR
Biological: 13vPnC + TIV

Interventions

13-valent pneumococcal conjugate vaccineBIOLOGICAL

Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.

13vPnC+TIV Followed by Placebo 1 month later
13vPnC + TIVBIOLOGICAL

Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.

Placebo+TIV Followed by 13vPnC 1 month later

Eligibility Criteria

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

You may qualify if:

  • Generally healthy male or female adults 65 years of age or older.
  • Available for the duration of the trial - approximately 2 months.
  • No previous vaccination with any pneumococcal vaccine.
  • No history of severe adverse reaction associated with a vaccine.
  • No allergy to egg proteins (eggs or egg products) and chicken proteins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

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

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of 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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 17, 2012

Results First Posted

February 17, 2012

Record last verified: 2012-01