Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

October 31, 2014 updated by: Sanofi Pasteur, a Sanofi Company

Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.

Primary Objective:

To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
538

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Antique
      • General Santos City, Antique, Philippines
    • Bataan
      • Calamba, Bataan, Philippines
    • Batangas
      • Marikina City, Batangas, Philippines
      • Montalban, Batangas, Philippines
      • Navotas City, Batangas, Philippines
      • Noveleta, Batangas, Philippines
      • Olongapo City, Batangas, Philippines
      • Paranaque, Batangas, Philippines
      • Pasay, Batangas, Philippines
      • Pasig, Batangas, Philippines
      • Plaridel, Batangas, Philippines
      • Quezon City, Batangas, Philippines
    • Benguet
      • Angeles City, Benguet, Philippines
      • Bacolod City, Benguet, Philippines
      • Baguio City, Benguet, Philippines
      • Baliwag, Benguet, Philippines
    • Bulacan
      • Cagayan De Oro City, Bulacan, Philippines
      • Cardona, Bulacan, Philippines
      • Cavite City, Bulacan, Philippines
      • Cebu, Bulacan, Philippines
    • Capiz
      • Cebu, Capiz, Philippines
    • Cavite
      • Muntinlupa, Cavite, Philippines
      • Naguila, Cavite, Philippines
      • Olongapo City, Cavite, Philippines
      • Ormoc City, Cavite, Philippines
      • Ortigas, Cavite, Philippines
      • Paranaque, Cavite, Philippines
      • Pasay, Cavite, Philippines
      • Pasig, Cavite, Philippines
      • Pasig City, Cavite, Philippines
      • Pulilan, Cavite, Philippines
      • Quezon City, Cavite, Philippines
    • Cebu
      • Quezon City, Cebu, Philippines
      • Roxas, Cebu, Philippines
      • San Fernando City, Cebu, Philippines
      • San Jose City, Cebu, Philippines
      • Sta. Rosa, Cebu, Philippines
    • Davao Del Norte
      • Tagug, Davao Del Norte, Philippines
    • Davao Del Sur
      • Sta. Rosa, Davao Del Sur, Philippines
      • Tacloban City, Davao Del Sur, Philippines
      • Taguig, Davao Del Sur, Philippines
      • Talisay City, Davao Del Sur, Philippines
      • Tarlac City, Davao Del Sur, Philippines
      • Taytay, Davao Del Sur, Philippines
      • Theresa, Davao Del Sur, Philippines
      • Valenzuela City, Davao Del Sur, Philippines
    • Ilocos Norte
      • Bacolod City, Ilocos Norte, Philippines
      • Baguio City, Ilocos Norte, Philippines
    • Iloilo
      • Dasmarinas, Iloilo, Philippines
      • General Santos City, Iloilo, Philippines
      • Iloilo City, Iloilo, Philippines
    • Isabela
      • Angeles City, Isabela, Philippines
      • Baguio City, Isabela, Philippines
    • LA Union
      • Alaminos City, LA Union, Philippines
    • La Union
      • Bacolod City, La Union, Philippines
    • Laguna
      • Muntinlupa, Laguna, Philippines
      • Ormoc City, Laguna, Philippines
      • Quezon City, Laguna, Philippines
    • Lanao Del Norte
      • Tacloban City, Lanao Del Norte, Philippines
      • Tanauan, Lanao Del Norte, Philippines
    • Leyte
      • Quezon City, Leyte, Philippines
      • San Fernando City, Leyte, Philippines
      • San Miguel, Leyte, Philippines
    • Misamis Oriental
      • Sta. Rosa, Misamis Oriental, Philippines
      • Taguig, Misamis Oriental, Philippines
      • Tarlac City, Misamis Oriental, Philippines
    • NCR
      • Batangas City, NCR, Philippines
      • Bocaue, NCR, Philippines
      • Cabanatuan City, NCR, Philippines
      • Calamba, NCR, Philippines
      • Caloocan City, NCR, Philippines
      • Cebu, NCR, Philippines
      • Concepcion, NCR, Philippines
      • Dagupan City, NCR, Philippines
      • Dasmarinas, NCR, Philippines
      • Davao City, NCR, Philippines
      • Fairview, NCR, Philippines
      • Guagua, NCR, Philippines
      • Iligan City, NCR, Philippines
      • Iloilo City, NCR, Philippines
      • Imus, NCR, Philippines
      • Kidapawan City, NCR, Philippines
      • La Trinidad, NCR, Philippines
      • Laoag City, NCR, Philippines
      • Las Pinas, NCR, Philippines
      • Las Pinas City, NCR, Philippines
      • Lipa, NCR, Philippines
      • Lipa City, NCR, Philippines
      • Los Banos, NCR, Philippines
      • Maasin City, NCR, Philippines
      • Makati, NCR, Philippines
      • Makati City, NCR, Philippines
      • Malabon City, NCR, Philippines
      • Malolos, NCR, Philippines
      • Mandaluyong, NCR, Philippines
    • NRC
      • Manila, NRC, Philippines
      • Marikina, NRC, Philippines
      • Marikina City, NRC, Philippines
    • Negros Occidental
      • Quezon City, Negros Occidental, Philippines
      • Roxas City, Negros Occidental, Philippines
      • San Fernando City, Negros Occidental, Philippines
      • San Jose Del Monte, Negros Occidental, Philippines
    • North Cotobato
      • Urdaneta City, North Cotobato, Philippines
    • Nueva Ecija
      • Baguio City, Nueva Ecija, Philippines
    • Pampanga
      • Batangas City, Pampanga, Philippines
      • Binan, Pampanga, Philippines
      • Cagayan De Oro City, Pampanga, Philippines
      • Caloocan City, Pampanga, Philippines
      • Cebu, Pampanga, Philippines
    • Pangasinan
      • Angeles City, Pangasinan, Philippines
      • Bacoor, Pangasinan, Philippines
      • Baguio City, Pangasinan, Philippines
      • Balanga City, Pangasinan, Philippines
    • Pasig City
      • Imus, Pasig City, Philippines
    • Rizal
      • Concepcion, Rizal, Philippines
      • Davao City, Rizal, Philippines
      • General Santos City, Rizal, Philippines
      • Imus, Rizal, Philippines
    • South Cotabato
      • Tacloban City, South Cotabato, Philippines
      • Tagum City, South Cotabato, Philippines
      • Tanauan, South Cotabato, Philippines
      • Tarlac City, South Cotabato, Philippines
      • Taytay, South Cotabato, Philippines
    • Southern Leyte
      • San Pedro, Southern Leyte, Philippines
    • Tarlac
      • Angeles City, Tarlac, Philippines
      • Bacolod City, Tarlac, Philippines
      • Baguio City, Tarlac, Philippines
    • Zambales
      • Batangas City, Zambales, Philippines
      • Calamba, Zambales, Philippines
      • Cauayan, Zambales, Philippines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 2 to 11 years of age on the day of inclusion (Group 1)
  • Aged 12 to 17 years of age on the day of inclusion (Group 2)
  • Aged 18 to 55 years of age on the day of inclusion (Group 3)
  • Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
  • Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
  • Provision of informed consent form signed by the subject (Group 3)
  • If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form
  • Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
  • For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).

Exclusion Criteria:

  • For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine during the present trial period
  • Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history
  • History of seizures
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection
  • Personal of family history of Guillain-Barré Syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Menactra® Group 1
Participants aged 2 to 11 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
  • Menactra®
EXPERIMENTAL: Menactra® Group 2
Participants aged 12 to 17 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
  • Menactra®
EXPERIMENTAL: Menactra® Group 3
Participants aged 18 to 55 on enrollment
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
  • Menactra®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
Time Frame: Day 0 up to Day 30 post-vaccination
Day 0 up to Day 30 post-vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®
Time Frame: Day 0 up to Day 30 post-vaccination
Day 0 up to Day 30 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi Pasteur, a Sanofi Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Sanofi Pasteur Philippines, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MTA71
  • U1111-1116-4853 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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