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

NCT01026038 | Completed Phase 3 Results

• 2 other identifiers: 6096A1-3021B1851016
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

13-valent Pneumococcal Vaccine; Immunization; Safety; Antibody Response

Keywords

Pneumococcal vaccine 13-valent

Outcome Measures

Primary Outcomes (3)

• Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine

  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.

  One month after vaccination

• Percentage of Participants With Prespecified Local Reactions

  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.

  Seven days after vaccination

• Percentage of Participants With Prespecified Systemic Events

  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.

  Seven days after vaccination

Secondary Outcomes (6)

• Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine

  Up to 7 days before vaccination

• Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine

  Four to seven days after vaccination

• Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine

  Up to 7 days before vaccination

• Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine

  One month after vaccination

• Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine

  One month after vaccination

Study Arms (1)

1

EXPERIMENTAL

1 dose (0.5 mL), IM of 13vPnC vaccine.

Biological: 13-valent pneumococcal conjugate vaccine

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).

1

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Pfizer Investigational Site

Ancenis, 44150, France

Location

Pfizer Investigational Site

Bondues, 59910, France

Location

Pfizer Investigational Site

Brest, 29200, France

Location

Pfizer Investigational Site

Châlons-en-Champagne, 51100, France

Location

Pfizer Investigational Site

Draguignan, 83300, France

Location

Pfizer Investigational Site

Essey-lès-Nancy, 54270, France

Location

Pfizer Investigational Site

Écully, 69130, France

Location

Pfizer Investigational Site

Floirac, 33270, France

Location

Pfizer Investigational Site

Garges Les Gonesses, 95140, France

Location

Pfizer Investigational Site

Joué-lès-Tours, 37300, France

Location

Pfizer Investigational Site

Le Havre, 76600, France

Location

Pfizer Investigational Site

Lingolsheim, 67380, France

Location

Pfizer Investigational Site

Lyon, 69007, France

Location

Pfizer Investigational Site

Maromme, 76150, France

Location

Pfizer Investigational Site

Moûtiers, 73600, France

Location

Pfizer Investigational Site

Nancy, 54000, France

Location

Pfizer Investigational Site

Nice, 06300, France

Location

Pfizer Investigational Site

Olonne-sur-Mer, 85340, France

Location

Pfizer Investigational Site

Strasbourg, 67000, France

Location

Pfizer Investigational Site

Strasbourg, 67100, France

Location

Pfizer Investigational Site

Talence, 33400, France

Location

Pfizer Investigational Site

Thionville, 57100, France

Location

Pfizer Investigational Site

Tours, 37000, France

Location

Pfizer Investigational Site

Villers-lès-Nancy, 54600, France

Location

Pfizer Investigational Site

Vitry-sur-Seine, 94400, France

Location

Related Links

• To obtain contact information for a study center near you, click here.

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 8, 2012
• Results First Posted: February 8, 2012

Record last verified: 2012-01

Locations

FR (25)