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

NCT01432262 | Completed Phase 3 Results

• 2 other identifiers: B18510486115A1-3020
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 4

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.

Conditions

Pneumococcal Infections

Keywords

prevention of pneumococcal diseases

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (2)

• Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination

  One month (28 to 42 days) after vaccination

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination

  Pre-vaccination to 1 month (28 to 42 days) after vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

=\> 65 years of age

Biological: vaccine-13vPnC

Group 2

EXPERIMENTAL

50 to 64 years of age

Biological: vaccine-13vPnC

Interventions

vaccine-13vPnC BIOLOGICAL

Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)

Also known as: 13-valent pneumococcal conjugate vaccine

Group 1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Instituto Mexicano de Investigación Clínica, S.A. de C.V

México, D.f., 06700, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

Star Medica

Morelia, Michoacán, CP 58070, Mexico

Location

Hospital General de Durango

Durango, 34000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 25499011 DERIVED

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: September 12, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 25, 2013
• Results First Posted: January 8, 2013

Record last verified: 2013-01

Locations

ME (4)