NCT00824655

Brief Summary

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

7 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

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 18, 2011

Completed
Last Updated

August 10, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

January 16, 2009

Results QC Date

June 17, 2011

Last Update Submit

August 4, 2011

Conditions

Pneumococcal Vaccines

Keywords

Healthy SubjectsVaccinesPneumococcal

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose

    Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

    1 month after the toddler dose (13 months of age)

Secondary Outcomes (3)

  • Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose

    1 Month after the infant series (6 months of age)

  • GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose

    1 Month after the infant series (6 months of age)

  • GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose

    12 months of age (prior to toddler dose)

Other Outcomes (4)

  • Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)

    Day 1 through Day 7 after vaccination

  • Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)

    Day 1 through Day 7 after vaccination

  • Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)

    Day 1 through 7 after vaccination

  • +1 more other outcomes

Study Arms (2)

Group 1

EXPERIMENTAL
Biological: 13vPnC

Group 2

EXPERIMENTAL
Biological: 13vPnC

Interventions

13vPnCBIOLOGICAL

13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.

Group 1

Eligibility Criteria

Age140 Days - 392 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children previously immunized with 1 or 2 doses of Prevenar.
  • Group 1: Male or female subjects between the age of \>=140 and \<=196 days of age at time of enrollment.
  • Group 2: Male or female subjects between the age of \>=336 and \<=392 days of age at time of enrollment
  • Available for entire study period.

You may not qualify if:

  • Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
  • Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pfizer Investigational Site

Eskilstuna, SE-63188, Sweden

Location

Pfizer Investigational Site

Gothenburg, SE-40014, Sweden

Location

Pfizer Investigational Site

Malmo, SE-20502, Sweden

Location

Pfizer Investigational Site

Örebro, SE-70185, Sweden

Location

Pfizer Investigational Site

Östersund, SE-83183, Sweden

Location

Pfizer Investigational Site

Uddevalla, SE-45180, Sweden

Location

Pfizer Investigational Site

Umeå, SE-90185, Sweden

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
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 10, 2011

Results First Posted

July 18, 2011

Record last verified: 2011-08

Locations

SE(7)