Clinical trial NCT00689351: Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Vaccine
Keywords: Prevention
against
pneumococcal
disease
Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 180
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 month after the infant series (7 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
Other outcomes:
measure: Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series (7 months of age)
measure: Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose
timeFrame: 1 month after the Toddler Dose (13 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 4 days after dose 1 (2 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 days after dose 2 (4 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after dose 3 (6 months of age)
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after toddler dose (12 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 4 days after dose 1 (2 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 days after dose 2 (4 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after dose 3 (6 months of age)
measure: Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
timeFrame: Within 4 days after toddler dose (12 months of age)
Locations:
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Bupyeong-gu
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Jongno-gu
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Jung-gu
city: Kyunggi
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Koyang
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seodaemun-gu
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Yeongdeungpo-gu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.