Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

Pneumococcal Vaccine Clinical Trial

Official title:

Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689351
• Other study ID #: 6096A1-010
• Secondary ID: B1851001
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2008
• Last updated: June 24, 2011
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

Inclusion Criteria:

• Healthy 2-month-old-infants (42 to 98 days)

• Available for the entire study period (14 months)

Exclusion Criteria:

• Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine

• A previous severe reaction to any vaccine or vaccine-related component

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Vaccine

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
• 7-valent pneumococcal conjugate vaccine
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Incheon	Jung-gu
Korea, Republic of	Pfizer Investigational Site	Incheon	Bupyeong-gu
Korea, Republic of	Pfizer Investigational Site	Kyunggi	Koyang
Korea, Republic of	Pfizer Investigational Site	Seoul	Seodaemun-gu
Korea, Republic of	Pfizer Investigational Site	Seoul	Yeongdeungpo-gu
Korea, Republic of	Pfizer Investigational Site	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (=) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series	Percentage of participants achieving predefined antibody threshold =0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).	1 month after the infant series (7 months of age)	No
Secondary	Percentage of Participants Achieving a Serotype-specific IgG Antibody Level =0.35 Mcg/mL Measured 1 Month After the Toddler Dose	Percentage of participants achieving predefined antibody threshold =0.35Mcg/mL along with the corresponding 95% CI was calculated 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). Exact 2-sided CI was based on the observed percentage of participants.	1 month after the toddler dose (13 months of age)	No

External Links

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