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

Purpose

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.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: vaccine-13vPnC	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumococcal Infections

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination [ Time Frame: One month (28 to 42 days) after vaccination ] [ Designated as safety issue: No ]
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.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination [ Time Frame: Within 14 days after vaccination ] [ Designated as safety issue: Yes ]
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).
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination [ Time Frame: Within 14 days after vaccination ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 1 Month (28 to 42 days) after vaccination ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination [ Time Frame: One month (28 to 42 days) after vaccination ] [ Designated as safety issue: No ]
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.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination [ Time Frame: Pre-vaccination to 1 month (28 to 42 days) after vaccination ] [ Designated as safety issue: No ]
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.

Enrollment:	324
Study Start Date:	July 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 => 65 years of age	Biological: vaccine-13vPnC Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1) Other Name: 13-valent pneumococcal conjugate vaccine
Experimental: Group 2 50 to 64 years of age	Biological: vaccine-13vPnC Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1) Other Name: 13-valent pneumococcal conjugate vaccine

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432262

Locations

Mexico
Instituto Mexicano de Investigación Clínica, S.A. de C.V
Mexico, D.f., Mexico, 06700
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, DF, Mexico, 14000
Star Medica
Morelia, Michoacan, Mexico, CP 58070
Hospital General de Durango
Durango, Mexico, 34000

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01432262 History of Changes
Other Study ID Numbers:	B1851048, 6115A1-3020
Study First Received:	June 22, 2011
Results First Received:	December 4, 2012
Last Updated:	January 18, 2013
Health Authority:	Mexico: Board of Health (BOH)

Keywords provided by Pfizer:

prevention of pneumococcal diseases

Additional relevant MeSH terms:

Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013