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

Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026038
• Other study ID #: 6096A1-3021
• Secondary ID: B1851016
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2009
• Last updated: January 5, 2012
• Start date: April 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Ancenis
France	Pfizer Investigational Site	Bondues
France	Pfizer Investigational Site	Brest
France	Pfizer Investigational Site	Chalons En Champagne
France	Pfizer Investigational Site	Draguignan
France	Pfizer Investigational Site	Ecully
France	Pfizer Investigational Site	Essey Les Nancy
France	Pfizer Investigational Site	Floirac
France	Pfizer Investigational Site	Garges Les Gonesses
France	Pfizer Investigational Site	Joue Les Tours
France	Pfizer Investigational Site	Le Havre
France	Pfizer Investigational Site	Lingolsheim
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Maromme
France	Pfizer Investigational Site	Moutiers
France	Pfizer Investigational Site	Nancy
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Olonne Sur Mer
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Talence
France	Pfizer Investigational Site	Thionville
France	Pfizer Investigational Site	Tours
France	Pfizer Investigational Site	Villers Les Nancy
France	Pfizer Investigational Site	Vitry Sur Seine

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Secondary	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	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.	Up to 7 days before vaccination	No
Secondary	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	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.	Four to seven days after vaccination	No
Secondary	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	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.	Up to 7 days before vaccination	No
Secondary	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	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.	One month after vaccination	No
Secondary	Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine	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.	One month after vaccination	No
Secondary	Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine	Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.	One month after vaccination	No

External Links

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