NCT00366548

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

14 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

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 15, 2012

Completed
Last Updated

August 15, 2012

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

August 17, 2006

Results QC Date

March 26, 2010

Last Update Submit

July 6, 2012

Conditions

Vaccines, Pneumococcal

Keywords

VaccineInfant

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series

    Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 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) are presented.

    One month after 3-dose infant series (at 5 months of age)

  • Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series

    GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented.

    One month after 3-dose infant series (at 5 months of age)

Secondary Outcomes (2)

  • Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose

    one month after the toddler dose (at 13 months of age)

  • Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose

    one month after the toddler dose (at 13 months of age)

Other Outcomes (2)

  • Percent of Participants Reporting Pre-Specified Local Reactions

    Within 4-days after each dose

  • Percentage of Participants Reporting Pre-Specified Systemic Events

    Within 4-days after each dose

Study Arms (2)

1

EXPERIMENTAL
Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80

2

ACTIVE COMPARATOR
Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

Interventions

13 valent pneumococcal conjugate vaccine with Polysorbate 80BIOLOGICAL
1
13 valent pneumococcal conjugate vaccine without Polysorbate 80BIOLOGICAL
2

Eligibility Criteria

Age42 Days - 98 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 2 months (42 through 98 days) at the time of enrollment.
  • Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
  • In good health as determined by medical history, physical examination, and judgment of the investigator.
  • Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.

You may not qualify if:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • Known or suspected immune deficiency or suppression.
  • History of culture-proven invasive disease caused by S pneumoniae.
  • Major known congenital malformation or serious chronic disorder.
  • Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
  • Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies \[eg, Synagis\]).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Bydgoszcz, 85-168, Poland

Location

Unknown Facility

Dębica, 39-200, Poland

Location

Unknown Facility

Krakow, 30-663, Poland

Location

Unknown Facility

Krakow, 31-202, Poland

Location

Unknown Facility

Krakow, 31-422, Poland

Location

Unknown Facility

Lodz, 91-347, Poland

Location

Unknown Facility

Lubartów, 21-100, Poland

Location

Unknown Facility

Lublin, 20-044, Poland

Location

Unknown Facility

Oborniki Śląskie, 55-120, Poland

Location

Unknown Facility

Poznan, 60-535, Poland

Location

Unknown Facility

Poznan, 61-709, Poland

Location

Unknown Facility

Siemianowice Śląskie, 41-103, Poland

Location

Unknown Facility

Torun, 87-100, Poland

Location

Unknown Facility

Trzebnica, 55-100, Poland

Location

Related Publications (1)

  • Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.

    PMID: 25126854DERIVED

MeSH Terms

Interventions

Polysorbates

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Poland, WPWZMED@wyeth.com

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 15, 2012

Results First Posted

August 15, 2012

Record last verified: 2012-07

Locations

PL(14)