You are here

Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Canberra Hospital
Garran, Australian Capital Territory, 2605 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-14 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
of the investigator, can and will comply with the requirements of the protocol.

- A male or female between, and including, 12 and 14 months of age at the time of the
first vaccination.

- Written informed consent obtained from the parent(s)/LAR(s) of the subject.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Vaccination records showing the completion of the full primary vaccination schedule
with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine
according to local recommendations at least 5 months before the study entry.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Child in care.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccines within 30 days preceding the first dose of study vaccine or planned use
during the study period.

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs within six months prior to the first vaccine dose. For
corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and
topical steroids are allowed.

- Planned administration/administration of a vaccine not foreseen by the study protocol
within the period starting 30 days before and ending 30 days after the dose of
vaccines, with the exception of a licensed inactivated influenza vaccine. Measles,
Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can
be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can
be administered after the last blood sampling (at Visit 2 or 4 depending on the
group).

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational vaccine/product (pharmaceutical product or device).

- Previous vaccination against Neisseria meningitidis.

- Previous booster vaccination against Streptococcus pneumoniae.

- Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani
and Bordetella pertussis.

- History of meningococcal disease.

- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
or secondary), including human immunodeficiency virus (HIV) infection, based on
medical history and physical examination (no laboratory testing required)*

- Note: With the exception of HIV rapid testing which will be done for subjects in
South Africa.

- Family history of congenital or hereditary immunodeficiency.

- History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to
be exacerbated by any component of the vaccines.

- Major congenital defects or serious chronic illness.

- History of any neurological disorders or seizures, including Guillain-Barré syndrome
(GBS). History of a simple, single febrile seizure is permitted.

- Acute disease and/or fever at the time of enrollment.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.

NCT01939158
Pfizer
Active, not recruiting
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now