Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
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
2 other identifiers
interventional
180
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 11, 2011
CompletedJune 28, 2011
June 1, 2011
1.5 years
May 29, 2008
December 10, 2010
June 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
1 month after the toddler dose (13 months of age)
Other Outcomes (10)
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series
1 month after the infant series (7 months of age)
Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose
1 month after the Toddler Dose (13 months of age)
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
Within 4 days after dose 1 (2 months of age)
- +7 more other outcomes
Study Arms (2)
1
EXPERIMENTAL13vPnC
2
ACTIVE COMPARATOR7vPnC
Interventions
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
Eligibility Criteria
You may qualify if:
- Healthy 2-month-old-infants (42 to 98 days)
- Available for the entire study period (14 months)
You may not qualify if:
- Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
- A previous severe reaction to any vaccine or vaccine-related component
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Pfizer Investigational Site
Incheon, Bupyeong-gu, 400-711, South Korea
Pfizer Investigational Site
Seoul, Jongno-gu, 110-744, South Korea
Pfizer Investigational Site
Incheon, Jung-gu, 400-711, South Korea
Pfizer Investigational Site
Kyunggi, Koyang, 412-270, South Korea
Pfizer Investigational Site
Seoul, Seodaemun-gu, 120-752, South Korea
Pfizer Investigational Site
Seoul, Yeongdeungpo-gu, 150-950, South Korea
Related Publications (1)
Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.
PMID: 23011012DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer Clinical Trials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 28, 2011
Results First Posted
January 11, 2011
Record last verified: 2011-06