Clinical trial NCT00840801: Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Official title: SINGLE-BLIND, RANDOMIZED, PHASE III B STUDY IN CHILDREN AGED 1 - 11 YEARS TO INVESTIGATE THE IMMUNOGENICITY, SAFETY AND INTERCHANGEABILITY OF TWO TICK-BORNE ENCEPHALITIS (TBE) VACCINES ADMINISTERED ACCORDING TO A CONVENTIONAL SCHEDULE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis, Tick-Borne
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 302
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).


Eligibility criteria: Inclusion Criteria:

Male and female children will be eligible for participation in this study if:

* they are aged \>= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;
* their parents / legal guardians provide written informed consent;
* children provide written assent to the study according to age and capacity of understanding;
* their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
* they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
* provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).

Exclusion Criteria:

Subjects will be excluded from participation if:

* they have a history of any previous TBE vaccination;
* they have a history of TBE infection;
* they have a history of infection with other flaviviruses;
* they have a history of vaccination against yellow fever and/or Japanese B encephalitis;
* they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;
* they are suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
* they have received any blood product or immunoglobulins within 90 days prior to study entry;
* they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study);
* they have a functional or surgical asplenia;
* they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation;
* they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product;
* they are pregnant or breastfeeding (if a female subject);
* they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
* Subjects who have an acute illness with or without elevated body temperature (\>=37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature \< 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) the center is still open for recruitment.
* If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later date, as long as the center is still open for recruitment.
* Subjects who received any live vaccine within 4 weeks or any inactivated vaccine within 2 weeks prior to the scheduled first study vaccination will not be vaccinated until an interval of 4 or 2 weeks, respectively, has passed, provided the center is still open for recruitment.
* If a subject was bitten by a tick within 4 weeks prior to the scheduled first or second vaccination, the vaccination must be postponed until an interval of 4 weeks has passed.

Primary outcomes:
measure: Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
timeFrame: 28 days after Vaccination 2
Secondary outcomes:
measure: Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
timeFrame: 180 days after the Vaccination 1, 28 days after the Vaccination 3
measure: Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
timeFrame: 28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
measure: Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
timeFrame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
measure: Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
timeFrame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
measure: Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
timeFrame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
measure: Fold Increase of Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
timeFrame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
measure: Frequency and Severity of Systemic Reactions Occurring After First Vaccination
timeFrame: Within 28 days after Vaccination 1
measure: Frequency and Severity of Systemic Reactions Occurring After Second Vaccination
timeFrame: Within 28 days after Vaccination 2
measure: Frequency and Severity of Systemic Reactions Occurring After Third Vaccination
timeFrame: Within 28 days after Vaccination 3
measure: Frequency and Severity of Injection Site Reactions Occurring After the First Vaccination
timeFrame: Within 6 days of Vaccination 1
measure: Frequency and Severity of Injection Site Reactions Occurring After the Second Vaccination
timeFrame: Within 6 days of Vaccination 2
measure: Frequency and Severity of Injection Site Reactions Occurring After the Third Vaccination
timeFrame: Within 6 days of Vaccination 3
measure: Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination
timeFrame: Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before Vaccination 3
measure: Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination
timeFrame: Within 28 days after Vaccination 3
Other outcomes:
Locations:
city: Eferding
country: Austria
facility: Unterer Graben 2
state: Upper Austria
city: Wels
country: Austria
facility: Grieskirchnerstr.17
state: Upper Austria
city: Havlickuv Brod
country: Czechia
facility: Private surgery of General Practitioner for children and juveniles
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
city: Pardubice-Polabiny
country: Czechia
facility: Chemiku 129
city: Pardubice
country: Czechia
facility: Private surgery of General Practitioner for children and juveniles
city: Pardubice
country: Czechia
facility: Private surgery of General Practitioner for children and juveniles
city: Pardubice
country: Czechia
facility: Private surgery of General Practitioner for children and juveniles
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Baxter BioScience
name: Baxter Bioscience Investigator
role: PRINCIPAL_INVESTIGATOR
References: