Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan.
- Conditions
- Prophylaxis against Neisseria meningitidis serogroups A, C, W135 and YTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-004973-17-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines and Diagnostics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 340
Individuals eligible for enrollment in this study were those:
1. who were of any gender, from the age of = 2 to = 18 years of age at the time of visit 1, and to whom the nature of the study had been explained and
a. the parent/legal representative had provided written informed consent.
b. had provided written assent (= 7 to = 18 years of age)
2. who the investigator believed that their parents/legal representatives would comply with the requirements of the protocol (e.g., completion of the diary card, return for the follow-up visit).
3. who were in good health as determined by
a. medical history
b. physical exam
c. clinical judgment of the investigator
4. who had a negative urine pregnancy test for female subjects = 11 years of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 341
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Individuals not eligible to be enrolled in the study were those:
1. who were unwilling or unable to give written informed assent or consent to participate in the study.
2. who were perceived to be unreliable or unavailable for the duration of the study period.
3. who had a previously confirmed or suspected disease caused by N meningitidis.
4. who had household contact with and/or intimate exposure to an individual with culture-proven N meningitidis infection within 60 days prior to enrolment.
5. who had previously been vaccinated with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
6. who had received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrolment or who expected to receive an investigational drug or vaccine prior to the completion of the study.
7. who had received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who were planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine could be administered up to 15 days prior to study vaccination and at least 15 days
after study vaccination).
8. who had experienced within the 7 days prior to enrolment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ?38 °C) within 3 days prior to enrollment.
9. who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who had epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
10. who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
11. who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
a. received immunosuppressive therapy within 30 days prior to enrolment (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrolment, or cancer chemotherapy)
b. received immunostimulants.
c. received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrolment and for the full length of the study
12. who were known to have a bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time.
13. who had Down’s syndrome or other known cytogenic disorders.
14. who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method