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

• ClinicalTrials.gov Identifier: NCT01026038
• Recruitment Status: Completed
• First Posted: December 4, 2009
• Results First Posted: February 8, 2012
• Last Update Posted: February 8, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
13-valent Pneumococcal Vaccine; Immunization; Safety; Antibody Response	Biological: 13-valent pneumococcal conjugate vaccine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 263 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: April 2010
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

Arm	Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.
2. Percentage of Participants With Prespecified Local Reactions [ Time Frame: Seven days after vaccination ]
   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.
3. Percentage of Participants With Prespecified Systemic Events [ Time Frame: Seven days after vaccination ]
   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 :

1. Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine [ Time Frame: Up to 7 days before vaccination ]
   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.
2. 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 ]
   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.
3. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine [ Time Frame: Up to 7 days before vaccination ]
   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.
4. Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine [ Time Frame: One month after vaccination ]
   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.
5. Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine [ Time Frame: One month after vaccination ]
   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.
6. 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 ]
   Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.

Eligibility Criteria

• Ages Eligible for Study: 3 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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, 67000

Pfizer Investigational Site

Strasbourg, France, 67100

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:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01026038
• Other Study ID Numbers: 6096A1-3021; B1851016
• First Posted: December 4, 2009
• Results First Posted: February 8, 2012
• Last Update Posted: February 8, 2012
• Last Verified: January 2012

Keywords provided by Pfizer:

Pneumococcal vaccine 13-valent

Additional relevant MeSH terms:

Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors; Physiological Effects of Drugs