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:

Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants After a Hepatitis B Birth Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317187
• Other study ID #: 100791
• Status: Completed
• Phase: Phase 3
• Start date: June 8, 2004
• Est. completion date: January 16, 2005

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: January 16, 2005
• Est. primary completion date: January 16, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 56 Days to 83 Days

Eligibility

Inclusion criteria:

• Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.

Exclusion criteria:

• Any confirmed immunodeficient condition, based on medical history and physical examination.

• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) 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) of immunosuppressants or other immune-modifying drugs since birth.

• Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.

• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.

• History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

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
Thailand	GSK Investigational Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Thailand, 

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