A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-28

Study Completion Date

2012-10-05

Brief Summary

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The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.

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Detailed Description

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In this study Influenza vaccine GSK1562902A is the primary study vaccine and Havrix™ will be administered as the active comparator and not co-administered along with the study vaccine.Therefore, there exist no relation between the vaccines administered in this study. As the study will be carried out in Philippines, Havrix™ vaccine will be used as an active comparator instead of saline placebo to offer an advantage to the subjects.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group

Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.

Group Type EXPERIMENTAL

Influenza vaccine GSK1562902A Formulation 1

Intervention Type BIOLOGICAL

Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group

Influenza vaccine GSK1562902A Formulation 2

Intervention Type BIOLOGICAL

Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group

Havrix™

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Havrix™ Junior

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

GSK1562902A Formulation 1 - Havrix / Havrix Jr Group

Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.

Group Type EXPERIMENTAL

Influenza vaccine GSK1562902A Formulation 1

Intervention Type BIOLOGICAL

Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group

Havrix™

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Havrix™ Junior

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

GSK1562902A Formulation 2 - Havrix / Havrix Jr Group

Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.

Group Type ACTIVE_COMPARATOR

Influenza vaccine GSK1562902A Formulation 2

Intervention Type BIOLOGICAL

Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group

Havrix™

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Havrix™ Junior

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Havrix / Havrix Jr Group

Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.

Group Type ACTIVE_COMPARATOR

Havrix™

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Havrix™ Junior

Intervention Type BIOLOGICAL

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Interventions

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Influenza vaccine GSK1562902A Formulation 1

Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group

Intervention Type BIOLOGICAL

Influenza vaccine GSK1562902A Formulation 2

Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group

Intervention Type BIOLOGICAL

Havrix™

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Intervention Type BIOLOGICAL

Havrix™ Junior

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:

* Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol .
* A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.
* Written informed consent obtained from the subject's parent or guardian. Assent obtained from the subject when applicable.
* Good general health as established by medical history and clinical examination before entering into the study.
* Comprehension by the subject's parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
* Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

* Child in care
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
* Active participation in other clinical trials.
* Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
* Acute disease and/or fever at the time of enrolment:
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
* Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine.
* History of seizures or progressive neurological disease.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Diagnosed with cancer or any chronic severe disease.
* Previous administration of any H5N1 vaccine.

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Alabang, Muntinlupa, , Philippines

Site Status

GSK Investigational Site

Quezon City, , Philippines

Site Status

Countries

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Philippines

References

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Izurieta P, Uy-Aragon MJ, Drame M, Vaughn DW. Assessment of Prime-boost Vaccination Using an AS03B-adjuvanted Influenza A (H5N1) Vaccine: A Randomized Trial in Children of Three to Less Than Eighteen Years of Age. Pediatr Infect Dis J. 2016 Feb;35(2):e35-47. doi: 10.1097/INF.0000000000000968.

Reference Type DERIVED

PMID: 26551446 (View on PubMed)

Study Documents

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