13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

Pneumococcal Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432262
• Other study ID #: B1851048
• Secondary ID: 6115A1-3020
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2011
• Last updated: January 18, 2013
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Board of Health (BOH)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• vaccine-13vPnC
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)
• vaccine-13vPnC
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)

Locations

Country	Name	City	State
Mexico	Hospital General de Durango	Durango
Mexico	Instituto Mexicano de Investigación Clínica, S.A. de C.V	Mexico	D.f.
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico	DF
Mexico	Star Medica	Morelia	Michoacan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination	Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.	One month (28 to 42 days) after vaccination	No
Primary	Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination	Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).	Within 14 days after vaccination	Yes
Primary	Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination	Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.	Within 14 days after vaccination	Yes
Primary	Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.	Baseline up to 1 Month (28 to 42 days) after vaccination	Yes
Secondary	Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination	Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.	One month (28 to 42 days) after vaccination	No
Secondary	Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination	Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	Pre-vaccination to 1 month (28 to 42 days) after vaccination	No

External Links

•   To obtain contact information for a study center near you, click here.