Clinical trial NCT00688870: Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
Official title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines
Pneumococcal Conjugate Vaccine
Keywords: Prevention against pneumococcal disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 168
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: no
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 Taiwan.


Eligibility criteria: Inclusion Criteria:

* Healthy 2-month-old infants (42 to 98 days)
* Available for the entire study period (14 months)

Exclusion Criteria:

* Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
* A previous anaphylactic reaction to any vaccine or vaccine-related component.

Primary outcomes:
measure: Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (mcg)/mL, 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 Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose
timeFrame: 1 month after toddler dose (16 months of age)
Other outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series
timeFrame: 1 month after the 3-dose infant series (7 months of age)
measure: GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (16 months of age)
measure: Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).
timeFrame: Within 4 days after Dose 1 of the infant series (2 Months of Age)
measure: Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 Days after Dose 2 of the infant series (4 months of age)
measure: Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after Dose 3 of the infant series (6 months of age)
measure: Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).
timeFrame: Within 4 days after the toddler dose (15 months of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
timeFrame: Within 4 days after Dose 1 of the infant series (2 months of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
timeFrame: Within 4 days after Dose 2 of the infant series (4 months of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
timeFrame: Within 4 days after dose 3 of the infant series (6 months of age)
measure: Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).
timeFrame: Within 4 days after the toddler dose (15 months of age)
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan Hsien
country: Taiwan
facility: Chang Gung Memorial Hospital - Linko
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22.