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Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

Primary Purpose

Diphtheria, Hepatitis B, Whole Cell Pertussis

Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Tritanrix-HepB/Meningitec conjugate vaccine
Tritanrix/Hiberix vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

undefined - 3 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria at study entry: Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Exclusion criteria at study entry: Any confirmed immunodeficient condition, based on medical history & physical examination. A family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute disease at the time of enrolment.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Hib-MenAC Lot 1 Group

Hib-MenAC Lot 2 Group

Hib-MenAC Lot 3 Group

Hiberix Group

Arm Description

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.

Outcomes

Primary Outcome Measures

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3

Secondary Outcome Measures

Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose
Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose
Occurrence of serious adverse events during the entire study period

Full Information

First Posted
February 15, 2006
Last Updated
August 13, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00317135
Brief Title
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
Official Title
Assess Reactogenicity and Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Months Age), After a Hepatitis B Birth Dose
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 11, 2003 (undefined)
Primary Completion Date
October 23, 2004 (Actual)
Study Completion Date
October 23, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
Detailed Description
Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth: - One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Hepatitis B, Whole Cell Pertussis, Haemophilus Influenzae Type b, Tetanus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hib-MenAC Lot 1 Group
Arm Type
Experimental
Arm Description
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Arm Title
Hib-MenAC Lot 2 Group
Arm Type
Experimental
Arm Description
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Arm Title
Hib-MenAC Lot 3 Group
Arm Type
Experimental
Arm Description
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Arm Title
Hiberix Group
Arm Type
Active Comparator
Arm Description
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.
Intervention Type
Biological
Intervention Name(s)
Tritanrix-HepB/Meningitec conjugate vaccine
Other Intervention Name(s)
DTPw-HBV/Hib-MenAc conjugate vaccine
Intervention Description
The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection
Intervention Type
Biological
Intervention Name(s)
Tritanrix/Hiberix vaccine
Other Intervention Name(s)
DTPw-HBV/Hib vaccine
Intervention Description
The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
Primary Outcome Measure Information:
Title
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
Time Frame
Days 0-3 post dose 1
Title
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2
Time Frame
Days 0-3 post dose 2
Title
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3
Time Frame
Days 0-3 post dose 3
Secondary Outcome Measure Information:
Title
Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose
Time Frame
Days 0-3 after each dose
Title
Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose
Time Frame
Day 0-30 after each dose
Title
Occurrence of serious adverse events during the entire study period
Time Frame
Day 0 up to Month 5

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria at study entry: Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Exclusion criteria at study entry: Any confirmed immunodeficient condition, based on medical history & physical examination. A family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute disease at the time of enrolment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

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