Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01026038
First received: December 2, 2009
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.


Condition Intervention Phase
13-valent Pneumococcal Vaccine
Immunization
Safety
Antibody Response
Biological: 13-valent pneumococcal conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
    Antibody GMC as measured by microgram/millilitre (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) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

  • Percentage of Participants With Prespecified Local Reactions [ Time Frame: Seven days after vaccination ] [ Designated as safety issue: Yes ]
    Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.

  • Percentage of Participants With Prespecified Systemic Events [ Time Frame: Seven days after vaccination ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.


Secondary Outcome Measures:
  • Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine [ Time Frame: Up to 7 days before vaccination ] [ Designated as safety issue: No ]
    IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

  • Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine [ Time Frame: Four to seven days after vaccination ] [ Designated as safety issue: No ]
    IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

  • Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine [ Time Frame: Up to 7 days before vaccination ] [ Designated as safety issue: No ]
    Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

  • Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
    Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

  • Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
    Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.

  • Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine [ Time Frame: One month after vaccination ] [ Designated as safety issue: No ]
    Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.


Enrollment: 263
Study Start Date: April 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1 dose (0.5 mL), IM of 13vPnC vaccine.
Biological: 13-valent pneumococcal conjugate vaccine
All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

Exclusion Criteria:

  • Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
  • History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026038

Locations
France
Pfizer Investigational Site
Ancenis, France, 44150
Pfizer Investigational Site
Bondues, France, 59910
Pfizer Investigational Site
Brest, France, 29200
Pfizer Investigational Site
Chalons En Champagne, France, 51100
Pfizer Investigational Site
Draguignan, France, 83300
Pfizer Investigational Site
Ecully, France, 69130
Pfizer Investigational Site
Essey Les Nancy, France, 54270
Pfizer Investigational Site
Floirac, France, 33270
Pfizer Investigational Site
Garges Les Gonesses, France, 95140
Pfizer Investigational Site
Joue Les Tours, France, 37300
Pfizer Investigational Site
Le Havre, France, 76600
Pfizer Investigational Site
Lingolsheim, France, 67380
Pfizer Investigational Site
Lyon, France, 69007
Pfizer Investigational Site
Maromme, France, 76150
Pfizer Investigational Site
Moutiers, France, 73600
Pfizer Investigational Site
Nancy, France, 54000
Pfizer Investigational Site
Nice, France, 06300
Pfizer Investigational Site
Olonne Sur Mer, France, 85340
Pfizer Investigational Site
Strasbourg, France, 67100
Pfizer Investigational Site
Strasbourg, France, 67000
Pfizer Investigational Site
Talence, France, 33400
Pfizer Investigational Site
Thionville, France, 57100
Pfizer Investigational Site
Tours, France, 37000
Pfizer Investigational Site
Villers Les Nancy, France, 54600
Pfizer Investigational Site
Vitry Sur Seine, France, 94400
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01026038     History of Changes
Other Study ID Numbers: 6096A1-3021, B1851016
Study First Received: December 2, 2009
Results First Received: October 25, 2011
Last Updated: January 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Pfizer:
Pneumococcal vaccine 13-valent

ClinicalTrials.gov processed this record on September 22, 2014