Clinical trial NCT01432262: 13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico
Official title: A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who Are Naive To 23-Valent Pneumococcal Polysaccharide Vaccine in Mexico.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: prevention of pneumococcal diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 324
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.


Eligibility criteria: Inclusion Criteria:

* Male or female older than 50 years of age
* Eligibility must be determined by medical history, physical exam and clinical judgment
* Able to complete an electronic diary
* Available for duration of study
* Negative pregnancy test for subjects in group 2 age 50 to 64 years
* Practice abstinence or use reliable birth control if age is 50 to 64 years

Exclusion Criteria:

* History of allergic reaction to any vaccine
* Previous vaccination with licensed or experimental pneumococcal vaccine
* S. pneumonia infection within past 5 years before investigational product administration
* Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
* Receipt of plasma products or immunoglobulins within 60 days
* Bleeding conditions or diathesis
* Receipt of investigational product within 28 days before study entry
* Other severe acute or chronic medical or psychiatric condition

Primary outcomes:
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination
timeFrame: One month (28 to 42 days) after vaccination
measure: Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination
timeFrame: Within 14 days after vaccination
measure: Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination
timeFrame: Within 14 days after vaccination
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 1 Month (28 to 42 days) after vaccination
Secondary outcomes:
measure: Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination
timeFrame: One month (28 to 42 days) after vaccination
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination
timeFrame: Pre-vaccination to 1 month (28 to 42 days) after vaccination
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Mexicano de Investigación Clínica, S.A. de C.V
state: D.f.
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
city: Morelia
country: Mexico
facility: Star Medica
state: Michoacan
city: Durango
country: Mexico
facility: Hospital General de Durango
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tinoco JC, Juergens C, Ruiz Palacios GM, Vazquez-Narvaez J, Enkerlin-Pauwells HL, Sundaraiyer V, Pathirana S, Kalinina E, Gruber WC, Scott DA, Schmoele-Thoma B. Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults >/= 50 years of age in Mexico. Clin Vaccine Immunol. 2015 Feb;22(2):185-92. doi: 10.1128/CVI.00711-14. Epub 2014 Dec 10.