NCT00708682

Brief Summary

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

9 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

June 27, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 25, 2011

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

1.8 years

First QC Date

June 27, 2008

Results QC Date

January 28, 2011

Last Update Submit

October 24, 2011

Conditions

Vaccines, Pneumococcal

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series

    Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of participants.

    1 month after the infant series (7 months of age)

Secondary Outcomes (2)

  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series

    1 month after dose 2 of the infant series (5 months of age)

  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose

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

Other Outcomes (11)

  • Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series

    Dose 2 of infant series (4 months of age)

  • GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series

    Dose 3 of infant series (6 months of age)

  • GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose

    Toddler Dose (12 months of age)

  • +8 more other outcomes

Study Arms (1)

A

EXPERIMENTAL
Biological: 13-valent pneumococcal conjugate vaccine

Interventions

13-valent pneumococcal conjugate vaccineBIOLOGICAL
A

Eligibility Criteria

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

You may qualify if:

  • Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
  • Able to complete three blood draws during study
  • At least 3.5 kg at enrollment

You may not qualify if:

  • Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
  • Immune deficiency, bleeding disorder or significant chronic medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Guadalajara, Jalisco, 44080, Mexico

Location

Unknown Facility

Distrio Federal, Mexico, 14080, Mexico

Location

Unknown Facility

Distrio Federal, Mexico, 4530, Mexico

Location

Unknown Facility

Morelia, Michoacán, 58070, Mexico

Location

Unknown Facility

Cuernavaca, Morelos, 62508, Mexico

Location

Unknown Facility

Monterrey, Nuevo León, 64460, Mexico

Location

Unknown Facility

Oaxaca City, Oaxaca, 71220, Mexico

Location

Unknown Facility

Puebla City, Puebla, 72190, Mexico

Location

Unknown Facility

Mérida, Yucatán, 9700, Mexico

Location

Related Publications (1)

  • Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

    PMID: 23965217DERIVED

Results Point of Contact

Title
Pfizer Clinical Trials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquires@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
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 2, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 25, 2011

Results First Posted

February 25, 2011

Record last verified: 2011-10

Locations

ME(9)