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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01026038
• Date of registration: 02/12/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
• Scientific 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
• Date of first enrolment: April 2010
• Target sample size: 263
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01026038
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 3 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Safety

13-valent Pneumococcal Vaccine

Antibody Response

Immunization

Intervention(s)

Biological: 13-valent pneumococcal conjugate vaccine

Primary Outcome(s)

Percentage of Participants With Prespecified Systemic Events [Time Frame: Seven days after vaccination]

Percentage of Participants With Prespecified Local Reactions [Time Frame: Seven days after vaccination]

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]

Secondary Outcome(s)

Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine [Time Frame: Up to 7 days before vaccination]

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]

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine [Time Frame: Up to 7 days before vaccination]

Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine [Time Frame: One month after vaccination]

Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine [Time Frame: One month after vaccination]

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]

Secondary ID(s)

6096A1-3021

B1851016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01026038