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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317135
• Other study ID #: 759346/004
• Status: Completed
• Phase: Phase 3
• Start date: December 11, 2003
• Est. completion date: October 23, 2004

Study information

• Verified date: August 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

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™

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 23, 2004
• Est. primary completion date: October 23, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Tetanus
• Whole Cell Pertussis

Intervention

Biological:
• Tritanrix-HepB/Meningitec conjugate vaccine
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
• Tritanrix/Hiberix vaccine
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.

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Muntinlupa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1		Days 0-3 post dose 1
Primary	Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2		Days 0-3 post dose 2
Primary	Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3		Days 0-3 post dose 3
Secondary	Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose		Days 0-3 after each dose
Secondary	Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose		Day 0-30 after each dose
Secondary	Occurrence of serious adverse events during the entire study period		Day 0 up to Month 5