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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01270503
• Date of registration: 04/01/2011
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
• Scientific title: 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
• Date of first enrolment: December 2010
• Target sample size: 538
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01270503
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Philippines

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur Philippines, Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 2 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Meningococcal Disease

Meningitis

Intervention(s)

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Primary Outcome(s)

Safety Overview Within 30 Days in Participants Vaccinated With Menactra® [Time Frame: Day 0 up to Day 30 post-vaccination]

Secondary Outcome(s)

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]

Secondary ID(s)

MTA71

U1111-1116-4853

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/11/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01270503